Abstract
Background
The evidence and infrastructure needed to access and deliver cardiac rehabilitation (CR) services are absent or lacking in low and middle-income countries (LMICs), resulting in a substantial loss of potential health and socio-economic benefits. Home-based programmes provide an affordable model of delivery that can leverage a scalable increase in CR access in LMICs. ACROSS (Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study) seeks to co-develop (with patients, caregivers, clinicians, and service commissioners) a culturally and contextually applicable and affordable home-based programme for people with the multimorbidity of coronary heart disease and/or heart failure with co-existing depression and/or anxiety and evaluate the acceptability, clinical effectiveness, and cost-effectiveness of its implementation in Bangladesh, India, and Pakistan and to determine its scalability and sustainability.
Methods
Four linked work packages (WPs). WP1 (cultural adaptation/refinement of home-based rehabilitation): examine rehabilitation implementation barriers/enablers from multiple stakeholder perspectives and co-develop a feasible and acceptable culturally & contextually adapted home-based programme, extended to take account of co-existing depression and/or anxiety; WP2 (external pilot): assess feasibility/acceptability of the co-developed rehabilitation intervention and study design and processes necessary for a full-scale trial; WP3: (multicentre/multi-country hybrid effectiveness and implementation randomised trial) determine the clinical and cost-effectiveness of a culturally adapted home-based rehabilitation intervention for people with coronary heart disease and/or heart failure and depression and/or anxiety; WP4 (capacity building): build research and rehabilitation delivery capacity.
Conclusions
The ACROSS programme overarching goal is to develop a clinically and cost-effective CR model in low-resource settings for people in Bangladesh, India, and Pakistan with a multimorbidity of heart disease and depression and/or anxiety with the potential for substantial health and socio-economic benefits.
Keywords: cardiac rehabilitation, mental health, coronary artery disease, heart failure, randomised controlled trial, low and middle income country.
PLAIN LANGUAGE SUMMARY
The combination of heart disease alongside depression and anxiety is a common and profound unmet need for global health systems, especially in low and middle-income country settings. It affects people of working age, causing them ill-health and major financial loss. Cardiac rehabilitation is recommended as a core component of health services and includes exercise, education, and psychological support. It has been shown to reduce death rate and hospital admissions and improve the quality of life. However, cardiac rehabilitation services in low- and middle-income countries are virtually absent.
Working with partners in Bangladesh, Pakistan, and India, the ‘Affordable Cardiac Rehabilitation: An Outreach Interdisciplinary Strategic Study’ (ACROSS) programme seeks to develop and evaluate the implementation of a clinically effective, affordable, and culturally and contextually appropriate model of home-based rehabilitation. ACROSS has four work packages: (1) Engagement events with those with lived-disease experience, their families, healthcare staff, and service providers to co-develop a culturally and contextually adapted home-based rehabilitation ('ACROSS') programme and training materials for providers; (2) A pilot study to understand if the ACROSS programme is acceptable and practical for patients and staff and whether a full-scale trial is doable; (3) A trial in 3000 patients with multiple long-term conditions that include heart disease and depression and anxiety across several sites in each country to tell us whether the programme improves health outcomes at 12-months and what its affordability is; and (4) Develop a sustainable model of workforce training and implementation to enable long-term programme delivery as well as build partner research capacity.
People with lived-disease experience, clinicians, community leaders, and healthcare policymakers have been extensively involved in the planning of ACROSS. Our stakeholder meetings have consistently emphasised the importance of this research and supported the development of our research plans. Patients and stakeholders in each partner country will provide ongoing advice.
Introduction
Background
In January 2024, the National Institute for Health and Care Research (NIHR) on Interventions for Global Health Transformation (RIGHT) programme approved the funding of ‘Affordable Cardiac Rehabilitation: An Outreach Inter-disciplinary Strategic Study (ACROSS)’. ACROSS is a global research programme that seeks to address the question of whether the implementation of an adapted home-based rehabilitation programme for people with multimorbidity that includes coronary heart disease and/or heart failure with a co-existence of depression and/or anxiety in Bangladesh, India and Pakistan, is clinically effective and cost-effective compared to usual care alone. This paper presents the rationale, study design and protocol for the ACROSS programme.
Rationale
Burden of heart disease & a mental health disorder. Cardiovascular disease (CVD) is the most prevalent non-communicable disease, the leading cause of global mortality, and a major contributor to premature disability and ill-health. CVD causes an estimated 17.8 million deaths worldwide, corresponding to 330 million years of life lost and another 35.6 million years lived with disability 1, 2 . By 2030, it is estimated that >80% of CVD-related disability and death will occur in low and middle-income countries (LMICs) due to increasing risk factors (e.g., hypertension, smoking, diabetes, obesity) 2, 3 . South Asia contributes to the highest proportion of CVD burden compared to other regions globally 4 . Socio-economic effects are particularly marked in LMICs, where CVD more frequently affects those of working age and is estimated to result in a decrease in gross domestic product of approximately 7% 5 .
The burden of CVD is further exacerbated by the co-presence of one or more chronic diseases - so-called ‘multimorbidity’ 6 . A common and burdensome multimorbidity is the combination of heart disease and depression or anxiety. Depression and anxiety act both as a risk factor for the development of heart disease and substantially increase the burden of heart disease 7 . Recent data show depression and anxiety to be highly prevalent in people with heart disease and may even be higher in South Asian populations (e.g., 70.4% depression in heart failure) 8– 10 . The addition of a mental health problem is associated with a 40–50% increased risk of mortality and major cardiac events and a 30–50% reduction in health-related quality of life (HRQoL) in people with heart disease 11, 12 .
Need for cardiac rehabilitation (CR). Cardiac rehabilitation (CR) is a complex secondary prevention intervention that aims to improve HRQoL, optimise functioning and disease self-management, and minimise the risk of recurrent cardiac events in people with heart disease 13 . It comprises of core components that include exercise training, medication management, risk factor management, and psychological support delivered by multidisciplinary teams, including nurses, physiotherapists, dieticians, and physicians.
There is strong evidence supporting the effectiveness and safety of CR programmes, especially for people with CHD and heart failure. The 2021 Cochrane review of 85 randomised trials of CR in CHD (23,430 patients) reported a 12% reduction (relative risk (RR): 0.88; 95% confidence interval (CI): 0.68 to 1.04) in cardiovascular mortality and a 42% reduction (relative risk: 0.58; 95% CI 0.43 to 0.77) in hospital admissions compared to usual care 14 . The 2024 Cochrane review of 60 randomised trials of CR in heart failure (8,728 patients) shows a 31% reduction (RR 0.69; 95% CI: 0.56 to 0.86) in hospital admissions 15 . Both Cochrane reviews show CR participation is associated with substantial improvements in exercise/functional capacity, patient HRQoL, and mental well-being 14, 15 . For those who develop a mental health diagnosis before or following their cardiac event, meta-analyses have shown significant and consistent improvements in their levels of depression and anxiety following CR participation 16 .
Despite its clinical and cost-effectiveness and international guidelines recommending its use, CR remains globally underutilised 17 . This is particularly the case in LMICs, where there are typically few CR programmes due to a lack of public health funding and healthcare professional capacity 18, 19 . An international survey published in 2019, reported that some 50% of countries currently have CR programmes, with the lowest availability in LMICs 19 . Similar findings were also observed in the Southeast Asian region 20 . Furthermore, most evidence supporting CR has come from high-income countries 14, 15 .
The potential of home-based CR delivery. Given constraints in their healthcare infrastructure, LMICs require affordable, scalable, and context-appropriate CR approaches 21 . These include home and community-based programmes supported by accessible digital technologies (e.g., internet and mobile phones) and training for healthcare staff to ensure quality of CR delivery. Home-based programmes can also reduce barriers to CR access and uptake, reducing the need for travel to hospital centres and flexibility to allow rehabilitation to fit around employment commitments 17 .
There is strong evidence that home-based programmes delivering the core components of rehabilitation and supported by healthcare staff can improve patient outcomes to those seen in more traditional centre/hospital-based programmes 22 . For example, the REACH-HF (Rehabilitation EnAblement in Chronic Heart Failure) trial in the UK showed that home-based rehabilitation significantly improved HRQoL and was cost-effective 23, 24 . The adjunct use of mobile technology (e.g., app-based delivery of education material/wearables such as accelerometers to track behaviour changes/web-based consultations) to a home-based programme provides a key opportunity to further enhance rehabilitation access and cost-effectiveness 25 . The COVID-19 pandemic resulted in a sea change in CR delivery 26 . Since then, CR has pivoted to home-based models and mobile technology (phone and web consultations replacing home visits plus provision of online facilitator training for healthcare staff) 26, 27 .
An interdisciplinary programme of implementation research is now needed to test whether a culturally and contextually appropriate affordable home-based delivery model of rehabilitation can be developed (alongside the necessary increases in healthcare staff delivery capacity) to be sufficiently scalable and sustainable to meet the vast current unmet secondary preventive burden of LMICs. A cost-effective CR model in low resource settings for people with multimorbidity that includes the high unmet need of heart disease, and a mental health condition has the potential to accrue substantial health and socio-economic benefits. The wider implementation of such an alternative affordable rehabilitation model also offers an important strategic opportunity to overcome suboptimal rehabilitation access and uptake experienced in high-income settings.
Protocol
Aims and objectives
The overarching aim of the ACROSS programme is the evaluation and implementation of a sustainable and scalable culturally and contextually adapted and affordable model of home-based rehabilitation for people with the multimorbidity that includes heart disease and a mental health disorder.
Specific research objectives:
-
1.
To co-design with key stakeholders a culturally and contextually adapted affordable home-based rehabilitation (‘ACROSS’) programme with low intensity inventions for depression and anxiety (Work Package 1 (WP1)).
-
2.
To co-design ACROSS delivery training for health professionals including a train-the-trainer programme to enable the cascade of training (WP1).
-
3.
To assess the feasibility and acceptability of implementing the ACROSS programme and trial design and examine the parameters and processes of a full-scale trial, including recruitment, randomisation, and retention (WP2).
-
4.
To determine the clinical effectiveness (hierarchical primary outcome of mortality, hospital admission, and health-related quality of life) of the ACROSS programme (WP3).
-
5.
To determine cost-effectiveness of the ACROSS programme in terms of an incremental cost per quality adjusted life year (WP3).
Cross-cutting objectives:
-
6.
To build research and clinical delivery capacity and capability and support south-south partnership and learning to underpin the scalable and sustainable country-wide provision of rehabilitation services (WP4).
-
7.
To embed community and stakeholder engagement to inform the route to impact of the project outputs and findings (WPs1–4).
Through our PhDs (see details in WP4 ‘Training & Capacity Building’ section below), to embed specific methodological research questions into the ACROSS programme. e.g., adapting complex intervention/co-design & co-development of interventions in the LMIC settings. Figure 1 provides a graphical summary of the timing and sequencing of the ACROSS WPs.
Figure 1. Summary of ACROSS WP.
Methods
All research will be performed in accordance with the principles stated in the Declaration of Helsinki. Prior to starting the programme of research (Q2/3 2025), ethical approval will be obtained for all individual protocols from the local institutional review board (IRB) or other appropriate ethics committee to confirm the study meets national and international guidelines for research on humans. Written participant informed consent for all studies will be obtained.
Patient and Public Involvement
From the outset of the ACROSS programme, we have embedded Community Engagement and Involvement (CEI)/Patient and Public Involvement and Engagement (PPIE) groups in each of our three LMIC countries. Our research plans (research questions/design and conduct of the study/outcomes measures/recuitment strategy) have been developed alongside patients and the public in our partner countries. Our communications manager will coordinate a project dissemination plan with our partner PPIE/CEI stakeholder and patient groups. All materials will be available in local languages and given potential challenges of patient/family literacy, we will seek to ensure materials are appropriately visual and to improve accessibility.
WP1 - Cultural and contextual adaptation of rehabilitation intervention
Adapting and implementing existing evidence-based interventions to new contexts can introduce new services into new environments that are cost-effectively and timely, with reasonable prospects of successful outcomes 28 . A goal of adaptation is to maintain the effectiveness of the intervention by preserving core features that account for success while delivering an intervention that is responsive to the new cultural and contextual setting.
WP1 aims to co-design and co-adapt a feasible, culturally acceptable and contextually adapted, affordable home-based rehabilitation (‘ACROSS’) programme (based on Heart Manual 29, 30 and REACH-HF 23, 24 ) developed and proven in the UK and tested in principle in a single centre trial in Bangladesh 31 . It will now be adapted for people with CHD or heart failure in Bangladesh, India, and Pakistan and extended to take account of multimorbidity, including depression and anxiety. We will incorporate and co-adapt low-intensity cognitive behaviour therapy interventions for depression and anxiety (including behavioural activation/cognitive restructuring/problem solving) into the Heart Manual and REACH-HF interventions. In addition, we will develop a facilitator training programme for healthcare practitioners and an associated train-the-trainer programme, to enable the upscaling of delivery capacity.
Objectives:
Examine the population, patient, and provider contexts in which the home-based rehabilitation would be delivered in our three partner countries.
Co-design and co-adapt a feasible, culturally acceptable and contextually adapted home-based rehabilitation (‘ACROSS’) programme developed for people with multimorbidity that includes coronary heart disease and heart failure and depression or anxiety.
Co-design an interactive facilitator training package that can be delivered remotely to ensure scalability and sustainability of the ACROSS programme delivery.
Co-produce a train-the-trainer facilitator and supervision package for ACROSS.
To achieve our objectives, we will conduct two interrelated studies:
-
1.
Study 1A - Patient and Provider Contexts: This qualitative study will explore implementation barriers and enablers through semi-structured interviews with national health informants and focus groups with health professionals and patients. The aim is to understand the local healthcare contexts and prepare for a broader trial. The Consolidated Framework for Implementation Research (CFIR) 32 will guide data collection, focusing on factors like the perceived advantages of the intervention, leadership engagement, and existing care pathways.
-
2.
Study 1B - Intervention Co-Design: This study will use Normalisation Process Theory 33 to co-design the ACROSS rehabilitation programme. Collaborating with patients, healthcare workers, and professionals, the team will adapt existing interventions and create new training resources. Consensus processes will ensure the programme aligns with the cultural and contextual needs of the target population.
WP2 - External pilot trial
WP2 aims to determine the feasibility/acceptability of the ACROSS intervention (co-designed in WP1) and study design and to gather information to examine the parameters and processes of a full-scale trial (WP3), including recruitment, randomisation, and retention.
Objectives:
Assess participant recruitment and retention.
Assess the ACROSS programme feasibility and acceptability, exploring barriers and facilitators to uptake and engagement from both participant and healthcare provider perspectives.
Assess the fidelity and reach of the ACROSS programme and, if necessary, further refine the intervention.
Assess the feasibility and acceptability of data collection tools and obtain estimates of key cost drivers.
Assess whether progression criteria are met, and a full randomised trial (WP3) is warranted.
Study Design: A randomised external pilot study with embedded process and economic evaluations. The overarching aim of the external pilot is to implement the co-adapted ACROSS programme developed in WP1 across two sites in each of Bangladesh, India, and Pakistan and to assess the feasibility of a full randomised trial (WP3).
Target population & Setting: see WP3.
Sample Size and Randomisation: To address the objectives of this pilot trial, 100 patients 34 from two centres in each of the three partner countries will be recruited over 5 months and randomised as outlined in WP3.
Intervention: ACROSS programme (see WP1), alongside usual care.
Control: No rehabilitation; usual care alone.
Outcomes & Progression Criteria: Key outcomes will focus on whether progression criteria are met to proceed to a definitive trial. Patient data will be collected at baseline (pre-randomisation) and 4 months post-randomisation, and economic evaluations will measure key cost drivers like healthcare utilisation and social care.
Process Evaluation: This will assess the feasibility and acceptability of the intervention and study design, following MRC guidelines 35 . Data will include fidelity checks of intervention delivery, interviews with patients and staff, and analysis of barriers to engagement 36 .
Data Analyses: The study will be reported according to the CONSORT extension for pilot and feasibility studies 33 . Quantitative data will be analysed descriptively, while qualitative data will undergo thematic analysis. Themes related to intervention delivery will be interpreted through Normalisation Process Theory (NPT) 37 .
WP3 - Hybrid effectiveness-implementation trials of ACROSS rehabilitation
This multicentre, multi-country study evaluates the clinical and cost-effectiveness of the ACROSS rehabilitation programme for individuals with multimorbidity, including heart disease and mental health disorders, across three South Asian countries. It also investigates factors influencing wider implementation in low- and middle-income countries (LMICs).
Objectives:
-
1.
Assess the clinical effectiveness of ACROSS alongside usual care compared to standard treatment alone.
-
2.
Evaluate cost-effectiveness in the three participating countries.
-
3.
Conduct an implementation analysis to understand scalability.
Study Design: Type 1 hybrid effectiveness-implementation randomised controlled trial (RCT) with an embedded economic evaluation 37, 38 . Participants will be individually randomised (1:1) to receive ACROSS plus usual care or usual care alone. The study will take place in publicly and privately funded healthcare settings.
Participants & inclusion criteria: Adults (≥18 years) hospitalised for acute myocardial infarction, unstable angina, coronary intervention, or heart failure (ejection fraction <45%) with co-existing mild-to-severe depression (Patient Health Questionnaire-9 [PHQ-9] score ≥5) and/or anxiety (General Anxiety Disorder-7 [GAD-7] ≥5) are eligible 39, 40 . Exclusions include contraindications to exercise, advanced dementia, or conditions preventing safe home-based rehabilitation.
Intervention & Control: It is anticipated that intervention CHD patients will receive an adapted ACROSS version of the Heart Manual intervention 29– 31 , and heart failure patients will receive an adapted ACROSS version of the REACH-HF intervention 23, 24 . The final details of the ACROSS program intervention will be confirmed following an extensive co-design process (in WP1) and feasibility testing (in WP2). All participants, including controls, will receive usual medical management by national guidelines.
Primary outcome: A composite of mortality, hospital days, and HRQoL (HeartQoL questionnaire) at 12 months, and analysed using the Win Ratio method 41, 42 . To calculate the Win Ratio, each intervention group participant is compared with each control group participant. If the intervention group participant has a “better” outcome, it is called a “win”, whereas if the control group participant does better, it is a “loss.” Otherwise, it is a “tie”.
Secondary & implementation outcomes: Includes individual elements of the primary outcome, depression, anxiety, exercise capacity, physical activity, risk factors, and safety events. Implementation outcomes assess reach, adherence, and acceptability.
Sample size: the study employs a simulation-based approach for sample size calculations in Win Ratio analyses, assuming a 12-month mortality rate of 13% and hospitalisation rate of 0.2 per person per year. The intervention is expected to reduce all-cause mortality (hazard ratio 0.85) and hospitalisations (incidence rate ratio 0.75) 14, 15 . Simulations indicate that a two-level Win Ratio analysis provides comparable power to a non-parametric analysis of days alive out of hospital (DAOH). However, achieving sufficient power requires incorporating health-related quality of life improvements as third level (see Figure 2). A sample size of 1000 patients per country ensures >89% power, accounting for a 20% loss to follow-up.
Figure 2. Sample size estimation for WP3.
Recruitment: will span 12 months, with a 4-month internal pilot to check recruitment feasibility, aiming for 336 participants per country. Data collection will take place at baseline, and 4- and 12 months post-randomisation.
Data analysis: The Statistical Working Group will develop a common Statistical Analysis Plan, which will be approved before unblinded analysis. Primary analyses will estimate the Win Ratio considering mortality, hospital days, and HRQoL. Additional regression models and subgroup analyses will be conducted. Missing data will be handled through multiple imputations in sensitivity analyses.
Economic evaluation: will assess cost-effectiveness in low-resource settings, incorporating direct and indirect costs using EQ-5D-5L data. Sensitivity analyses will explore cost variations. Within-trial results will be reported and presented as an incremental cost-utility ratio with the joint distribution of cost/utility pairs being represented on the cost-effectiveness plane and with a cost-effectiveness acceptability curve 43 employing cost-effectiveness thresholds based on country per capita gross domestic product (GDP) values and benchmark values (e.g., World Health Organisation [WHO]). Analyses will explore cost effectiveness in subgroups as defined earlier. Recent guidance on conducting economic evaluations in LMIC settings reported by the National Institute of Care Excellence (NICE) International 44 will be adhered to as well as reporting standards such as the Consolidated Health Economic Evaluation Reporting Standards statement 45 .
Qualitative analyses: will assess intervention fidelity and contextual factors through interviews and thematic coding.
WP4 - Capacity building
The primary goal of WP4 is to enhance research capacity in our LMICs and foster knowledge exchange between the UK and LMICs. The ACROSS project partners with three organisations: the International Council of Cardiovascular Prevention and Rehabilitation (ICCPR), the Heart Manual Office UK, and the Global Health Network (TGHN). These organisations provide expertise in online rehabilitation training and global health research support.
Objectives:
Supporting PhD studentships.
Building research and rehabilitation delivery capacity in partner countries.
Enhancing understanding of complex intervention trials in LMICs.
Developing a virtual training hub hosted on the ACROSS website.
Key challenges identified by LMIC partners involve the need for training in large-scale research, particularly RCTs, and scaling up rehabilitation services. The project aims to develop equitable partnerships, enabling knowledge transfer between the UK and LMICs and facilitating south-to-south learning. The project will follow the WHO’s ESSENCE principles to strengthen research capacity 46 .
WP4's training plan includes both face-to-face and virtual activities. In-person training activities will involve researchers from LMIC countries visiting the UK for methodological training and UK trainers visiting LMIC countries to run rehabilitation training and ‘train the trainer’ courses. To maximise accessibility and minimise the carbon footprint of ACROSS, these activities may be adapted to virtual formats. A core element of WP4 is to establish a virtual training hub, providing access to online materials and courses in global health research.
The capacity building efforts already underway include several virtual events including workshops on research theory, mental health forums, and seminars on adapting interventions. ACROSS will promote accreditation for training to enhance the professional development of participants and facilitate future research collaborations.
Research and methodological training will focus on building capacity for RCTs and intervention development, which is essential for the project’s other work packages. This will include training approximately 45 researchers from partner countries in areas including patient-public involvement (PPI), qualitative research, trial methods, health economics, and data analysis. The Glasgow Clinical Trial Unit will coordinate the training and will be supported by materials from global health research networks, including the MRC Research Trials Methodology Partnership.
Rehabilitation service capacity will be built through partnerships with ICCPR and the Heart Manual Office, which will deliver training on home-based rehabilitation programmes. This will include an online ‘train the trainer’ programme, enabling sustainable rehabilitation practices.
A key part of WP4 is the PhD training programme, supporting 8 studentships across the three LMIC countries. These students will work on projects related to the ACROSS programme, global trial methodology, mental health, and rehabilitation. The PhD students will be supported by local LMIC and UK supervisor teams, with access to training materials from the ACROSS hub and opportunities to attend webinars and workshops. To support postdoctoral research, WP4 plans to include activities such as grant writing workshops to help early career researchers submit high-quality grant applications.
Community engagement & public involvement
Community engagement involvement/patient public involvement engagement (CEI/PPIE) has been embedded into the ACROSS research programme development. Going forward we will seek the following key areas of CEI/PPIE direction: (i) participation in co-development/co-adaptation of our home-based rehabilitation intervention/training materials (WP1); (ii) ongoing advice on all aspects of our research including development of all participant facing documentation (e.g. participant information leaflets), participant recruitment strategies, patient interview guide, and interpretation of qualitative data, writing lay summaries etc; (iii) direction on dissemination/targeting of impact, and (iv) increasing community awareness about comorbidity and decreasing stigma attached to mental health conditions.
Our partner countries have each established local CEI/PPIE that includes: (i) ‘stakeholder group’: regional/national healthcare policymakers, key clinical opinion leaders, representatives of key healthcare professional groups (nursing/physiotherapy/ cardiology/psychology/psychiatry), community/regional leaders (including religious scholars), and senior healthcare providers/managers and (ii) ‘patient involvement group’: people with lived experience of heart disease and depression/anxiety and their families, facilitated by one of our local project team with fluency in local language(s). We expect our CEI/PPIE groups will meet on 3-4 occasions/year, with meetings facilitated by an experienced CEI/PPIE researcher from each country team.
To identify any gaps in skills/training CEI/PPIE contributors may require, we will develop/deliver an induction programme (as part of WP4) to clarify roles/expectations and build trust and rapport with the group members.
Together with our CEI/PPIE group we have developed the ACROSS programme theory of change (see Figure 3).
Figure 3. ACROSS Theory of Change model.
Conclusions
The overarching aim of the ACROSS programme to develop a clinically and cost-effective CR model in low resource settings for people with a multimorbidity of heart disease and depression and/or anxiety, offers huge potential health and socio-economic benefits in Bangladesh, India, and Pakistan. The wider implementation of such an affordable intervention model also offers an important strategic opportunity to overcome the problem of suboptimal rehabilitation access experienced in other low- and middle-income countries. We will seek to disseminate our findings widely, using a variety of approaches, supported by our stakeholder and patient advisory groups.
Acknowledgements
ACROSS Programme collaboration
Rezaul Karim, Ibrahim Cardiac Hospital & Research Institute, 122 Kazi Nazrul Islam Ave, Dhaka 1000, Bangladesh. Email: reza15353@yahoo.com ORCID: 0000-0002-8439-2499
Zia Ul Haq, Khayber Medical University, Peshawar, Pakistan. Email: drzia@kmu.edu.pk ORCID: 0000-0001-5124-2171
Nabila Soomro, Sindh Institute of Physical Medicine and Rehabilitation, Karachi. Email: nabila61@gmail.com ORICD: 0000-0001-5022-8829
Zainab F. Zadeh, Pakistan Institute of Learning and Living, Karachi, PK, Email: zainab.zadeh@pill.org.pk ORCID: 0000-0002-3043-6011 Sehrish Tofique
Ameer B. Khoso, Pakistan Institute of Learning and Living, Karachi, PK, Email: ameer.bukhsh@pill.org.pk ORCID: 0000-0003-2026-7952 Jamal Uddin
Sehrish Tofique, Pakistan Institute of Learning and Living, Karachi, PK, Email: sehrish.tofique@pill.org.pk ORCID: 0000-0002-8027-054X
Farhat Jafri, Karachi Medical and Dental College, Karachi. Email: drfajafri2003@yahoo.com ORCID: 0000-0003-2466-7283
Riffat Sultana, Karachi Institute of Heart Disease, Karachi. Email: dr_riffat2@hotmail.com
Huma Naeem, Sheikh Mohamed Bin Zayed Al Nahyan Institute of Cardiology- Baluchistan, Quetta. Email: royal.humanaeem@yahoo.com ORCID: 0000-0003-1998-2772
Palash Chandra Banik, Bangladesh University of Health Sciences (BUHS), 125/1, Darus Salam, Mirpur-1, Dhaka-1216, Bangladesh, Email: palashcbanik@buhs.ac.bd ORCID: 0000-0003-2395-9049
Sohel Choudhury, Department of Epidemiology & Research, National Heart Foundation Hospital & Research Institute, Plot-7/2, Section-2, Mirpur Dhaka, Dhaka, 1216 Bangladesh, Email: choudhurys@nhf.org.bd ORCID: 0000-0002-7498-4634
Louise Taylor, The Heart Manual Department, NHS Lothian, Astley Ainslie Hospital, 133 Grange Loan, Edinburgh, UK. Email: louise.taylor@nhs.scot ORCID: 0009-0003-4207-8105
Jamal Uddin, MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, School of Health and Wellbeing, University of Glasgow, Clarice Pears Building, 90 Byres Road, Glasgow G12 8TB, UK, Email: uddinj83@gmail.com ORCID: 0000-0001-5964-6381
Claire Copping, MRC/CSO Social and Public Health Sciences Unit School of Health and Wellbeing, University of Glasgow, Clarice Pears Building, 90 Byres Road, Glasgow G12 8TB, UK, Email: claire.copping@glasgow.ac.uk ORCID: N/a
David Innes, MRC/CSO Social and Public Health Sciences Unit, School of Health and Wellbeing, University of Glasgow, Clarice Pears Building, 90 Byres Road, Glasgow G12 8TB, UK, Email: david.innes@glasgow.ac.uk ORCID: 0009-0002-0954-3792
Sunil Roy TN, Consultant Cardiologist, Aster Medcity, Cochin, Kerala, India, Email: drsunil.roy@asterhospital.in ORCID: 0000-0003-4123-3313
Stigi Joseph, Consultant Cardiologist, Little Flower Hospital, Angamali, Kerala, India, Email: drstigi@yahoo.com
Vijayan Ganesan, Consultant Cardiologist, Aster MIMS Hospital, Kannur, Kerala, India, Email: writetovijayan@gmail.com
Mukund A Prabhu, Associate Professor, Department of Cardiology, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India, Email: mukundaprabhu@gmail.com
Jyothi Vijay MS, Assistant Professor, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, Thiruvananthapuram - 695 011, Kerala, India, Email: drvijaycardio@sctimst.ac.in
Ramya Das NK, Assistant Professor, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, Thiruvananthapuram - 695 011, Kerala, India, Email: dr.ramya87@sctimst.ac.in
We thank our Community Engagement and Involvement (CEI)/Patient and Public Involvement and Engagement (PPIE) groups for their contributions to date.
Funding Statement
This project is funded by the National Institute for Health Research (NIHR) under its Research and Innovation for Global Health Transformation (RIGHT) Programme (Grant reference - NIHR205540). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
[version 1; peer review: 1 approved, 2 approved with reservations]
Contributor Information
ACROSS Collaborative Group:
Rezaul Karim, Zia Ul Haq, Nabila Soomro, Zainab B Zadeh, Ameer Khoso, Sehrish Tofique, Farhat Jafri, Riffat Sultana, Huma Naeem, Palash Chandra Banik, Sohel Choudhury, Louise Taylor, Jamal Uddin, Claire Copping, David Innes, Sunil Roy TN, Stigi Joseph, Vijayan Ganesan, Mukund A Prabhu, Jyothi Vijay MS, and Ramya Das NK
Data availability
No data associated with this article.
References
- 1. Vaduganathan M, Mensah GA, Turco JV, et al. : The global burden of cardiovascular diseases and risk: a compass for future health. J Am Coll Cardiol. 2022;80(25):2361–2371. 10.1016/j.jacc.2022.11.005 [DOI] [PubMed] [Google Scholar]
- 2. Roth GA, Mensah GA, Johnson CO, et al. : Global burden of cardiovascular diseases writing group. Global burden of cardiovascular diseases and risk factors, 1990–2019: update from the GBD 2019 study. J Am Coll Cardiol. 2020;76(25):2982–3021. 10.1016/j.jacc.2020.11.010 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. World health association global status report on noncommunicable diseases 2010. Geneva, Switzerland,2011. Reference Source
- 4. Ramaraj R, Chellappa P: Cardiovascular risk in South Asians. Postgrad Med J. 2008;84(996):518–23. 10.1136/pgmj.2007.066381 [DOI] [PubMed] [Google Scholar]
- 5. Abegunde DO, Mathers CD, Adam T, et al. : The burden and costs of chronic diseases in low-income and middle-income countries. Lancet. 2007;370(9603):1929–38. 10.1016/S0140-6736(07)61696-1 [DOI] [PubMed] [Google Scholar]
- 6. The Academy of Medical Sciences: Multimorbidity: a priority for global health research.2018. Reference Source
- 7. Hare DL: Successful psychological treatment of depression and subsequent reduction in CVD events. Eur Heart J. 2023;44(18):1663–1665. 10.1093/eurheartj/ehad173 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8. Moradi M, Doostkami M, Behnamfar N, et al. : Global prevalence of depression among Heart Failure patients: a systematic review and meta-analysis. Curr Probl Cardiol. 2022;47(6): 100848. 10.1016/j.cpcardiol.2021.100848 [DOI] [PubMed] [Google Scholar]
- 9. Aw PY, Pang XZ, Wee CF, et al. : Co-prevalence and incidence of myocardial infarction and/or stroke in patients with depression and/or anxiety: a systematic review and meta-analysis. J Psychosom Res. 2023;165: 111141. 10.1016/j.jpsychores.2022.111141 [DOI] [PubMed] [Google Scholar]
- 10. Easton K, Coventry P, Lovell K, et al. : Prevalence and measurement of anxiety in samples of patients with Heart Failure: meta-analysis. J Cardiovasc Nurs. 2016;31(4):367–79. 10.1097/JCN.0000000000000265 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11. Dragioti E, Radua J, Solmi M, et al. : Impact of mental disorders on clinical outcomes of physical diseases: an umbrella review assessing population attributable fraction and generalized impact fraction. World Psychiatry. 2023;22(1):86–104. 10.1002/wps.21068 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12. Mulugeta H, Sinclair PM, Wilson A: Prevalence of depression and its association with health-related Quality of Life in people with heart failure in low- and middle-income countries: a systematic review and meta-analysis. PLoS One. 2023;18(3): e0283146. 10.1371/journal.pone.0283146 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13. Dalal HM, Doherty P, Taylor RS: Cardiac rehabilitation. BMJ. 2015;351: h5000. 10.1136/bmj.h5000 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 14. Dibben G, Faulkner J, Oldridge N, et al. : Exercise-based Cardiac Rehabilitation for Coronary Heart Disease. Cochrane Database Syst Rev. 2021;11(11): CD001800. 10.1002/14651858.CD001800.pub4 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15. Molloy C, Long L, Mordi IR, et al. : Exercise-based Cardiac Rehabilitation for adults with Heart Failure. Cochrane Database Syst Rev. 2024;3(3): CD003331. 10.1002/14651858.CD003331.pub6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. Zheng X, Zheng Y, Ma J, et al. : Effect of exercise-based Cardiac Rehabilitation on anxiety and depression in patients with myocardial infarction: a systematic review and meta-analysis. Heart Lung. 2019;48(1):1–7. 10.1016/j.hrtlng.2018.09.011 [DOI] [PubMed] [Google Scholar]
- 17. Taylor RS, Fredericks S, Jones I, et al. : Global perspectives on heart disease rehabilitation and secondary prevention: a scientific statement from the association of cardiovascular nursing and allied professions, European association of preventive cardiology, and international council of cardiovascular prevention and rehabilitation. Eur Heart J. 2023;44(28):2515–2525. 10.1093/eurheartj/ehad225 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18. Turk-Adawi K, Supervia M, Lopez-Jimenez F, et al. : Cardiac Rehabilitation availability and density around the globe. EClinicalMedicine. 2019;13:31–45. 10.1016/j.eclinm.2019.06.007 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19. de Melo Ghisi GL, Taylor RS, Seron P, et al. : Factors hindering Cardiac Rehabilitation in low- and middle-income countries, by level and setting. J Cardiopulm Rehabil Prev. 2023;43(2):143–144. 10.1097/HCR.0000000000000774 [DOI] [PubMed] [Google Scholar]
- 20. Chowdhury M, Heald FA, Turk-Adawi K, et al. : Availability and delivery of Cardiac Rehabilitation in South-East Asia: how does it compare globally? WHO South East Asia J Public Health. 2021;10(2):57–65. 10.4103/WHO-SEAJPH.WHO-SEAJPH_62_21 [DOI] [PubMed] [Google Scholar]
- 21. Grace SL, Turk-Adawi KI, Contractor A, et al. : Cardiac Rehabilitation delivery model for low-resource settings. Heart. 2016;102(18):1449–1455. 10.1136/heartjnl-2015-309209 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22. McDonagh ST, Dalal H, Moore S, et al. : Home-based versus centre-based Cardiac Rehabilitation. Cochrane Database Syst Rev. 2023;10(10): CD007130. 10.1002/14651858.CD007130.pub5 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23. Dalal HM, Taylor RS, Jolly K, et al. : The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: the REACH-HF multicentre randomized controlled trial. Eur J Prev Cardiol. 2019;26(3):262–272. 10.1177/2047487318806358 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24. Taylor RS, Sadler S, Dalal HM, et al. : The cost effectiveness of REACH-HF and home-based Cardiac Rehabilitation compared with the usual medical care for heart failure with reduced ejection fraction: a decision model-based analysis. Eur J Prev Cardiol. 2019;26(12):1252–1261. 10.1177/2047487319833507 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25. Rawstorn JC, Gant N, Direito A, et al. : Telehealth exercise-based Cardiac Rehabilitation: a systematic review and meta-analysis. Heart. 2016;102(15):1183–92. 10.1136/heartjnl-2015-308966 [DOI] [PubMed] [Google Scholar]
- 26. Babu AS, Arena R, Ozemek C, et al. : COVID-19: a time for alternate models in Cardiac Rehabilitation to take centre stage. Can J Cardiol. 2020;36(6):792–794. 10.1016/j.cjca.2020.04.023 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27. Purcell C, Purvis A, Cleland JGF, et al. : Home-based Cardiac Rehabilitation for people with heart failure and their caregivers: a mixed-methods analysis of the roll out an evidence-based programme in Scotland (SCOT:REACH-HF study). Eur J Cardiovasc Nurs. 2023;22(8):804–813. 10.1093/eurjcn/zvad004 [DOI] [PubMed] [Google Scholar]
- 28. Moore G, Campbell M, Copeland L, et al. : Adapting interventions to new contexts-the ADAPT guidance. BMJ. 2021;374: n1679. 10.1136/bmj.n1679 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29. Dalal HM, Evans PH, Campbell JL, et al. : Home-based versus hospital-based rehabilitation after myocardial infarction: a randomized trial with preference arms––Cornwall Heart Attack Rehabilitation Management Study (CHARMS). Int J Cardiol. 2007;119(2):202–11. 10.1016/j.ijcard.2006.11.018 [DOI] [PubMed] [Google Scholar]
- 30. Lewin B, Robertson IH, Cay EL, et al. : Effects of self help post-myocardial-infarction rehabilitation on psychological adjustment and use of health services. Lancet. 1992;339(8800):1036–40. 10.1016/0140-6736(92)90547-g [DOI] [PubMed] [Google Scholar]
- 31. Uddin J, Joshi VL, Moniruzzaman M, et al. : Effect of home-based Cardiac Rehabilitation in a lower-middle income country: results from a controlled trial. J Cardiopulm Rehabil Prev. 2020;40(1):29–34. 10.1097/HCR.0000000000000471 [DOI] [PubMed] [Google Scholar]
- 32. Damschroder LJ, Aron DC, Keith RE, et al. : Fostering implementation of health services research findings into practice: a Consolidated Framework for Advancing Implementation Science. Implement Sci. 2009;4: 50. 10.1186/1748-5908-4-50 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33. Braun V, Clark V: Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. 10.1191/1478088706qp063oa [DOI] [Google Scholar]
- 34. Eldridge SM, Chan CL, Campbell MJ, et al. : CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016;2: 64. 10.1186/s40814-016-0105-8 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 35. Moore GF, Audrey S, Barker M, et al. : Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350: h1258. 10.1136/bmj.h1258 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 36. Mellor K, Albury C, Dutton SJ, et al. : Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023;9(1): 59. 10.1186/s40814-023-01291-5 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 37. Murray E, Treweek S, Pope C, et al. : Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. 2010;8: 63. 10.1186/1741-7015-8-63 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 38. Wolfenden L, Foy R, Presseau J, et al. : Designing and undertaking randomised implementation trials: guide for researchers. BMJ. 2021;372: m3721. 10.1136/bmj.m3721 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 39. Kroenke K, Spitzer RL, Williams JB: The Patient Health Questionnaire-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. 10.1046/j.1525-1497.2001.016009606.x [DOI] [PMC free article] [PubMed] [Google Scholar]
- 40. Toussaint A, Hüsing P, Gumz A, et al. : Sensitivity to change and minimal clinically important difference of the 7–item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord. 2020;265:395–401. 10.1016/j.jad.2020.01.032 [DOI] [PubMed] [Google Scholar]
- 41. Pocock SJ, Ariti CA, Collier TJ, et al. : The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012;33(9):176–82. 10.1093/eurheartj/ehr352 [DOI] [PubMed] [Google Scholar]
- 42. Redfors B, Gregson J, Crowley A, et al. : The win ratio approach for composite endpoints: practical guidance based on previous experience. Eur Heart J. 2020;41(46):4391–4399. 10.1093/eurheartj/ehaa665 [DOI] [PubMed] [Google Scholar]
- 43. Fenwick E, Claxton K, Sculpher M: Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ. 2001;10(8):779–87. 10.1002/hec.635 [DOI] [PubMed] [Google Scholar]
- 44. NICE International: Bill and Melinda Gates Foundation. Methods for Economic Evaluation Project (MEEP),2014. Reference Source
- 45. Husereau D, Drummond M, Petrou S, et al. : Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Cost Eff Resour Alloc. 2013;11(1): 6. 10.1186/1478-7547-11-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 46. World Health Organisation: ESSENCE on health research. Revised2020. Reference Source