Pilot randomized controlled trial of a peer coach-led behavioral and educational intervention to enhance quality of life in patients living with hypersensitivity pneumonitis: Protocol for the RISE-HP study

Abstract

Background

Hypersensitivity Pneumonitis (HP) is an interstitial lung disease caused by an inhalational environmental exposure. Patients living with HP experience significant stress, uncertainty, and hypervigilance about the management of their disease and prognosis. These factors lead to reduced health-related quality of life (HRQOL), an important outcome that no interventions currently target.

Objective

The goal of this behavioral and educational intervention, RISE-HP, is to improve HRQOL in people who have HP. The objective of this pilot study is to assess feasibility, acceptability, and preliminary effectiveness of the RISE-HP intervention.

Methods

This pilot randomized controlled trial will be conducted in patients over the age of 18 with a diagnosis of HP. Forty participants will be randomly assigned to receive either the RISE-HP intervention (meetings with a peer coach focused on living well with their HP using cognitive behavioral techniques and motivational interviewing) or an attention control (general health education sessions with a research assistant) for 10 weeks. Participants will complete four additional study visits (enrollment, 5 weeks, 10 weeks, and 14 weeks after intervention start) for patient reported outcome measure completion. Primary implementation outcomes will be feasibility and acceptability. Secondary patient-centered effectiveness clinical outcomes will be improvement in HRQOL as measured by the Kings Brief Interstitial Lung Disease (KBILD) questionnaire. Additional secondary patient-reported clinical outcomes include fatigue, anxiety, depression, and self-efficacy.

Conclusion

Overall, this study addresses an important gap in HP care by targeting HRQOL and offers a novel non-pharmacologic patient-centered approach to therapy in patients with HP.

Article Highlights

• •Peer-led interventions using motivational interviewing and CBT principals may improve HRQOL in people with HP.

Glossary of terms:

Hypersensitivity Pneumonitis	HP
Health Related Quality of Life	HRQOL
Interstitial Lung Disease	ILD
Patient Activated Learning System	PALs
Pilot Randomized Controlled Trial	pilot-RCT
Patient Reported Outcome	PRO
Pulmonary Fibrosis Foundation	PFF
Weill Cornell Medicine	WCM

1. Background

Hypersensitivity pneumonitis (HP) is an interstitial lung disease (ILD) caused by exposure to an inhaled environmental antigen in a susceptible individual [1,2]. For many people, HP is a chronic lung condition with the potential to develop progressive pulmonary fibrosis resulting in significant morbidity, mortality, and reduced health related quality of life (HRQOL) [3]. Aside from avoidance of the exposure, which is challenging and unsuccessful in over 30-50% of patients [4,5], there are limited well studied pharmaceutical treatment options [6]. Many patients living with HP experience uncertainty, intense hypervigilance, feelings of anxiety and depression, and marked disruption of their lifestyle and home environment [7]. All these experiences reduce HRQOL, which was found to be lower in patients with HP than other forms of ILD [3]. Poor HRQOL in HP is also driven, in part, by patients’ profound lack of knowledge about the disease. Unfortunately, there is a dearth of reliable patient-centered information about HP [8]. The information that does exist about ILD and pulmonary fibrosis, for example on the internet, is often be unreliable, inaccurate, and/or outdated [[9], [10], [11]]. HRQOL is a priority patient-centered endpoint in ILD research [12]. Despite this, no intervention studies have targeted HRQOL as a primary endpoint in HP, and there are limited data on whether current therapies have a positive impact on the HRQOL of patients with HP.

Given the complex and multifactorial nature of HP, a biomedical approach may not capture the full spectrum of patient needs. The biopsychosocial model offers a comprehensive framework to tackle various aspects of the HP experience, recognizing that psychological distress, social isolation, and limited access to accurate information are not trivial, peripheral issues but central determinants of health [13]. There is a critical need for holistic interventions that prioritize emotional support, education, and empowerment alongside clinical management in HP. Given the significant role these emotional challenges play in shaping patient well-being, behavioral interventions have strong potential to improve psychological health, coping, and, consequently, enhance HRQOL. Similar interventions have demonstrated effectiveness in improving health status and reducing anxiety and depression symptoms in other chronic lung diseases, such as sarcoidosis [14] and COPD [15], supporting the relevance and adaptability of behavioral interventions for people living with HP.

Peer coaches provide support grounded in shared lived experience, which may enhance trust, relatability, and emotional validation beyond traditional clinician-led approaches. Patients with HP frequently experience isolation, uncertainty, and limited access to reliable disease-specific support, making peer-delivered interventions particularly well suited to improve coping, self-efficacy, and HRQOL. Peer support interventions have also demonstrated HRQOL improvement in other chronic diseases [16,17].

We hypothesize that people living with HP will benefit from targeted supportive care interventions that aim to decrease stress and uncertainty and improve well-being and quality of life. The primary objective of this report is to describe the protocol for a pilot randomized controlled trial (pilot-RCT) that will test a novel behavioral and educational intervention to improve HRQOL in HP.

2. Theoretical frameworks for the RISE-HP intervention

The development of the Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) intervention was guided by the integration of theory from three frameworks: 1. The living with HP HRQOL framework (HP-HRQOL) [7,18]; 2. The Biopsychosocial Model of Health and Disease [13]; and 3. Social Cognitive Theory [19,20]. In contrast to a biomedical model of disease, the biopsychosocial theory posits that health and disease are influenced by a variety of biologic, psychologic, and social factors. The interplay of these three domains determines health-related outcomes. In HP, we recognize that aside from biologic mechanisms, a person's social and psychologic state, and their reaction to this state, can have a profound impact on their experience living with the disease, and in turn impact HRQOL. In our previous work, we uncovered several important psychosocial constructs impacting HRQOL in people living with HP [7]; these are addressed in the weekly sessions of the RISE-HP intervention. By utilizing peer coaches, we have integrated Social Cognitive Theory, which postulates that an individual's actions and reactions, including their social behaviors and cognitive processes, are influenced by actions that the individual has observed among their peers [19]. The combination of a peer-delivered intervention that utilizes motivational interviewing and principles of cognitive behavioral therapy along with accurate disease specific education will address components of knowledge, reframing of expectations, and self-efficacy that we postulate will have a positive impact on overall HRQOL (Fig. 1). Collectively, these frameworks informed both the content and delivery of the intervention: the HP-HRQOL framework identified key psychosocial domains to target, the biopsychosocial model provided the conceptual rationale for addressing non-biologic contributors to HRQOL, and Social Cognitive Theory informed the peer-delivered behavioral intervention approach to improve coping, knowledge, and self-efficacy.

Fig. 1.

Proposed mechanism of the RISE-HP intervention.

Legend: A combination of tailored HP education and peer-delivered motivational interviewing (MI) and cognitive behavioral therapy (CBT) principles will improve health-related quality of life (HRQOL) by improving self-efficacy and knowledge, while reducing isolation and stress. Abbreviations: PALS = Patient Activated Learning System.

3. Methods and study design

3.1. Study objectives

This study aims to improve the HRQOL of people living with HP through a behavioral and educational intervention that aims to decrease stress and uncertainty and increase knowledge and self-efficacy around the disease. The long-term goal is to provide an intervention to patients with HP, with the intent to improve HRQOL and be delivered as a supplement to their existing clinical care. The objectives of this study are to test feasibility and acceptability of the RISE-HP intervention among adults living with HP and to obtain preliminary estimates of effectiveness. We hypothesize that the intervention will be feasible (85% of participants enrolled will complete the study) and acceptable (>85% of participants enrolled will find the intervention acceptable).

3.2. Study setting

All study activities will take place at Weill Cornell Medicine (WCM) in New York City, USA. Enrollment activities will take place either in person or virtually depending on participant preference. All study visits with peer coaches and subsequent visits with research assistants (RAs) will be conducted virtually, either by Zoom (preferred but not mandatory) or telephone. All patient reported outcomes (PRO) and survey data will be collected through the MyCap app, a freestanding mobile app that integrates with the REDCap research database and allows for remote participation for data collection, bi-directional messaging, task reminders, and linking to web-based resources [21].

3.3. Study design

In this single site, open label, parallel arm pilot-RCT, we plan to enroll 40 participants with HP and randomize them in a 1:1 ratio to the RISE-HP intervention or the “Staying Well” attention control arm (section 3.8.1). To examine whether the cognitive behavioral strategies integrated into the RISE-HP intervention are effective beyond merely speaking regularly with a friendly person, we use the educational “Staying Well” attention control condition for the comparison group. Participants will be active in the pilot-RCT for a total of 14 weeks (Fig. 2). Participants will complete 10 weekly sessions of either the intervention (delivered by peer coach) or attention control (delivered by a RA) followed by an assessment 4 weeks after completion of the sessions (week 14). Survey data will be collected from all participants at enrollment and weeks 5, 10, and 14 (Table 1). Participants in the RISE-HP intervention arm will also complete daily journaling, physical activity self-monitoring, and participate in exit interviews at week 11 (Table 1).

Fig. 2.

Diagram of RISE- study workflow.

Legend: The Reimagining Interventions for Support and Education in Hypersensitivity Pneumonitis (RISE-HP) study workflow outlines key stages of the intervention, including recruitment, randomization, intervention timeline, and data analysis.Abbreviations: PRO = Patient Reported Outcomes; RA = Research Assistant.

Table 1.

Schedule of RISE-HP trial events.

	Week
	0	1	2	3	4	5	6	7	8	9	10	11	14
RISE-HP or Control Administration		x	x	x	x	x	x	x	x	x	x
Informed consenta	x
Demographics	x
Medical history	x
Patient Reported Outcomes	x					x					x		x
Daily Journalingb		x	x	x	x	x	x	x	x	x	x
Daily Physical Activityb		x	x	x	x	x	x	x	x	x	x
Exit Surveys											x
Exit Interviewsb												x
Adverse event evaluation		X ------------------------------------------------------------------------------------------

^aInformed consent is the first procedure done during this period followed by screening. Once a person qualifies the additional activities in this time window will occur.

^bIntervention arm only. PROs: Patient Reported Outcomes.

Because the intervention discusses stress, uncertainty, and emotional well-being, PHQ-8 scores will be monitored by the research team. The research team will receive a notification from REDCap when a participant in the study, in either the control or intervention arm, scores ≥20 in the PHQ-8 each time PRO is collected at week 0, 5, 10, and 14. For participants who score ≥20, they will be referred to their clinician to discuss mental health counseling, and they will also be given mental health resources developed by Weill Cornell. Furthermore, peer coaches will receive additional training in recognizing, addressing, and reporting suicidality to the study team, should these concerns arise during intervention sessions. Protocols will be in place for the study team to assess for this and refer for appropriate care when necessary.

3.4. Stakeholder engagement

All aspects of the study and protocol (including design, procedures, study materials etc.) were developed with stakeholder input, which included patients living with HP, their caregivers, and clinicians who care for people living with HP. The development of the intervention and educational materials was informed by one-on-one interviews, structured group discussions, and surveys with stakeholders [5,7,8,18,22]. The research team met on average bimonthly over a two-year period with a patient advisory committee to conceptualize the study, discuss incorporation of broader stakeholder perspectives, and devise the protocol. Although clinicians contributed to the development of the intervention through stakeholder engagement activities, clinicians are not involved in the delivery or implementation of the intervention.

3.5. Study sponsorship and approval

The study is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health (K23HL163394). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. This trial is registered (NCT06811389) and approved by the Institutional Review Board of Weill Cornell Medicine (24-12028305).

3.6. Participant eligibility and recruitment

To be eligible for participation, patients will need to: be 18 years or older, have a documented diagnosis of HP determined by multidisciplinary discussion, speak English, have access to the internet, and reside within the United States. Participants will need to endorse verbal approval from their treating physician to participate in movement/physical activity. Patients will be excluded if they have severe cognitive impairment as determined by their treating physician, severe depression (Patient Health Questionnaire-8 [PHQ-8] score ≥20), or documentation in their medical chart of an eating disorder, active substance use disorder, suicidality, homicidality, acute posttraumatic stress disorder, or episodes of mania or psychosis, or if they are determined to be severely ill or moribund by the treating clinician.

Patients will be recruited using several strategies. We will recruit from the outpatient clinics at WCM. Charts will be pre-screened for the diagnosis of HP in the EMR prior to patient office visits and additional patients will be identified using an I2B2 query searching for diagnostic codes for HP and Pulmonary Fibrosis in EPIC. Patients may also provide a self-referral after learning about the study from their physician at WCM or an outside collaborating institution, by word of mouth, or after viewing posted study flyer advertisements. The study will also be advertised by community partners such as the Pulmonary Fibrosis Foundation (PFF) and through online social media postings. The study will capture data on recruitment source(s) identified by the participants.

Participants identified with HP who are interested in participating will undergo an enrollment and screening visit with the RA. During this visit, they will provide written (paper or electronic) informed consent and complete screening. If they are eligible to proceed, they will provide informed consent and be allocated to a study arm using block randomization (generated using permuted blocks of varying sizes by the study statistician). After randomization they will be asked to complete the baseline survey. Subjects assigned to the intervention arm will subsequently receive their peer coach assignment and instructions to schedule their first peer coach session. Those assigned to the control group will schedule their first attention control session with the RA. All participants will be provided appropriate study materials and be instructed on how to download and utilize the MyCap app.

3.7. Peer coach recruitment and training

Peer coaches are lay individuals with lived experience with the chronic condition under study (in this case HP) who are trained to provide practical, motivational, and emotional support, and to deliver a variety of behavioral interventions [23,24]. Peer coaches will act as community member consultants on the study, not research participants. Individuals will be eligible to become trained peer coaches if the following criteria are met: 1) have physician-diagnosed ILD, 2) express an interest in helping others with ILD, and 3) are willing to discuss aspects about living with ILD and HP and ways to reduce stress and improve quality of life. In addition, peer coaches will be required to speak English, have access to the internet and a telephone, and reside within the United States. Peer coaches will complete training led by a study investigator with support from the research team. They will be trained by the study team in motivational interviewing, basics of communication, goal setting, and the Patient Activated Learning System (PALs) education materials (section 3.8.2). The study team will walk each peer coach through the individual sessions and provide opportunities to practice delivery of the material for each session. Peer coaches will participate in several role play sessions. At the end of the training, peer coaches will receive certification of successful completion. To maintain relevance to HP, peer coaches with HP will be prioritized and training materials will be more specific to HP. For example, role playing scenarios will discuss fears relevant to HP and the peer coach handbook describes examples specific to HP, developed with feedback from patients living with HP. A description of intervention fidelity monitoring is described in section 3.11. A minimum of two peer coaches will be recruited to deliver the intervention.

3.8. Study conditions

3.8.1. Attention control “Staying Well” arm

The “Staying Well” attention control was developed by Dr. Iris Navarro Milan's research team at WCM [25]. It consists of 12 topics about general health and health screening, not specifically related to HP. Participants will choose 10 of the 12 topics and will meet weekly either via Zoom (preferred but not mandatory) or over the telephone with a RA for an estimated 30-45 min per session to cover one topic at a time. Selected topics will not be formally tracked because the topics are broadly similar in content and are intended to provide general health education. Therefore, variation in topic selection is not expected to meaningfully influence engagement or acceptability outcomes. There will be homework assignments for participants to complete prior to each session related to the upcoming educational material to be covered.

3.8.2. RISE-HP intervention arm

The RISE-HP intervention is modeled off the previously reported “Living Healthy” intervention [26]. “Living Healthy” is a peer coach delivered cognitive behavioral training intervention that was previously found to improve functioning, pain, quality of life, and self-reported physical activity in people living with type 2 diabetes [27]. The RISE-HP intervention utilizes the same principles as “Living Healthy” in a format developed specifically for people living with HP informed by stakeholder input. Participants will meet weekly with their peer coach for an estimated 30-45 min per session. Reminders of the session date and time will be sent on the MyCap app and emailed to the participant. Sessions will take place either via Zoom (encouraged but not mandatory) or telephone depending on patient preference. During the first session, participants and peer coaches will become acquainted, and participants will receive an overview of the structure of the program and be introduced to the idea of cognitive restructuring. They will work to build on the cognitive restructuring techniques weekly, incorporate them into the topic covered in each session, and learn specific techniques for stress reduction to practice daily. The participants will be asked to journal daily and answer daily questions related to their level of physical activity. As these activities are considered components of the RISE-HP intervention, comparable daily activities are not included in the attention control arm. Prior to each session participants will receive readings and/or videos to review related to the upcoming session's topic. The educational material will be from several sources, including the Patient Activated Learning System (PALs) and publicly available websites, such as the PFF and academic medical centers. The PALs is a digital health resource that provides answers to questions that come directly from patients in an easily understood format based on Adult Learning Theory and Bandura's Social Cognitive Theory [28,29]. Supplementary Material A outlines the weekly topics to be covered in the intervention.

3.9. Study outcomes

The primary implementation endpoints will be feasibility and acceptability. Feasibility will be measured by calculating enrollment and attrition rates. Feasibility will be defined as successful study completion by at least 85% of enrolled participants, with completion defined as attendance at week 10. Enrollment rate (number enrolled divided by number eligible and approached) will be recorded descriptively. Acceptability will be documented by session attendance and retention rates as well as through collection of an implementation survey at the end of the study and exit interviews. Session attendance will be assessed by the fraction of participants who attend 80% of sessions in control compared to intervention. The end of study implementation survey will also assess feasibility and acceptability on a 5-point Likert scale. The exit interviews will be conducted in the intervention arm only and these results will be analyzed and reported using qualitative methodology.

The secondary endpoints will include patient reported outcomes (PROs). Preliminary clinical effectiveness will be assessed using the Kings Brief Interstitial Lung Disease Questionnaire (KBILD) [30]. This questionnaire was developed to measure HRQOL specifically in people living with ILD and contains three domains: 1.) psychological 2) breathlessness and activity, 3.) chest symptoms. We will also collect measures of anxiety, depression, and fatigue, using the Generalized Anxiety Disorder (GAD-7) questionnaire [31], Patient Health Questionnaire-8 (PHQ-8) [32], and Fatigue Severity Scale (FSS) [33]. Self-efficacy will be measured using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) scales for self-efficacy for managing chronic conditions: 1.) “managing emotions,” and 2.) “managing daily activities” [34].

The primary exploratory assessment of preliminary effectiveness will focus on change in patient-reported outcomes from baseline to week 10. Week 14 assessments, conducted four weeks after intervention completion, are intended to evaluate short-term maintenance. Patient-reported outcomes collected at weeks 5, 10, and 14 will additionally allow exploratory evaluation of trends over time and trajectory of response across the study period.

3.10. Implementation and intervention evaluation

Implementation and intervention evaluation will occur at all phases of the study and through both survey and qualitative data collection (Table 2). In the intervention arm, we will collect patients’ daily reports of their level of physical activity and ask participants to journal daily. An exit survey developed using the Consolidated Framework for Implementation Research (CFIR) and the Reach-Effectiveness-Adoption-Implementation-Maintenance (RE-AIM) framework [[36], [37], [38], [39], [40], [41], [42]] will be administered to all participants at the conclusion of the study. CFIR will be used to guide assessment of implementation-related domains including feasibility, acceptability, fidelity, and appropriateness to future implementation of the intervention. RE-AIM will additionally inform evaluation of reach, engagement, and adoption outcomes. Study data will be utilized to evaluate reach of the intervention and maintenance will be evaluated by collection of PROs at week 14 (4 weeks post intervention completion). Participants in the intervention group will also undergo exit interviews modeled after the same frameworks with a member of the study team.

Table 2.

RISE-HP implementation evaluation.

Outcome		Measure	Mode of Data Collection
Implementation	Feasibility	•Recruitment and attrition of patients	•Implementation exit survey •Recruitment, enrollment and attendance data
	Acceptability	•Satisfaction with content, delivery, and comfort of the intervention. •Fraction of participants who attend 80% of sessions in control vs intervention. •Number of participants who complete all sessions, review PALs, complete homework	•Attendance and retention •Implementation exit survey •Exit interview
	Fidelity	•Program delivered as intended. •Quality of program delivery.	•Checklist modeled after Borrelli's treatment fidelity assessment [35]. •Qualitative exit interviews, review of peer coach session recordings.
	Appropriateness	•Perceived relevance and practicability.	•Implementation exit survey •Exit interview
Reach		•Number of participants who agree to participate compared to the number of eligible people approached. •Characteristics of participants vs nonparticipants. •Success of different avenues of recruitment.	•Recruitment data •Qualitative data
Effectiveness		•KBILD •FSS •PHQ-8 •GAD-7 •PROMIS Self Efficacy scales	•PRO data
Adoption		•Number of providers who refer patients by different centers. •Number of patients self-referred from different modes of advertisement.	•Recruitment data

Key: KBILD – King's Brief ILD; FSS – Fatigue Severity Scale; GAD-7–Generalized Anxiety Disorder-7; PROMIS – Patient Reported Outcome Measurement Information System; PALS – Patient Activated Learning System.

3.11. Intervention fidelity measures

We will record a minimum of three of the weekly Zoom conference sessions per participant, chosen at random, for both groups, and study staff will review the sessions using a checklist to assess intervention fidelity that will be modeled off of Borrelli's checklist for intervention fidelity in clinical trials [35]. Peer coaches will also have a checklist embedded in their guide that they will be asked to complete as they move through the session with the client. These checklists will be reviewed and compared to self-assessments of the coaches. The study team will also hold weekly teleconferences with peer coaches and have ongoing outreach to each peer coach individually throughout the intervention period. The number of sessions each participant completes will be documented.

3.12. Statistical methodology

3.12.1. Analytic plan for quantitative data

The primary goal of this pilot study is to assess the feasibility and acceptability and obtain preliminary estimates of treatment efficacy. Feasibility will be measured using recruitment and enrollment data to calculate recruitment and attrition halfway (5 weeks) through and at the end of the study. Acceptability will be documented by utilizing the exit survey and recording attendance at every session. We plan to enroll 40 participants with HP and randomly assign 20 to the RISE-HP arm and 20 to the attention control arm. With 40 participants (accounting for 15% attrition) randomized (1:1) to the treatment and attention control arms, we will have 80% power at α = 0.05 (two-tailed) to detect a large improvement (Cohen's d = 0.99) in HRQOL on the KBILD by 12 or more points. With this sample size, we will be able to obtain a preliminary estimate of the difference in HRQOL between the two arms with a half-width of 8.5 HRQOL points for the 95% CI. Taken together, the proposed sample size is consistent with the goal of establishing feasibility, obtaining a preliminary estimate of efficacy with reasonable precision and with power to achieve statistical significance of detecting a large sized effect.

We will use descriptive statistics (means and standard deviation, if normally distributed, or medians and inter-quartile range for continuous variables; frequency and percentage for categorical variables) to characterize baseline demographics, administrative data, and PRO responses, stratified by treatment groups and overall. Comparisons of PRO scores between intervention and control groups will be assessed using chi-square/Fisher's exact tests for categorical variables and two-sample t-tests or Wilcoxon Rank-Sum tests for continuous or ordinal variables, respectively. Missing responses for individual items on the PROs will be handled as suggested by the PRO developer. We will summarize the extent and patterns of missing PRO data at each timepoint. We will consider levels of missing outcome data that approach or exceed 20% to be potentially substantial and will evaluate the impact on study conclusions accordingly. In the event of substantial missing data, we will use a linear or generalized linear mixed model to estimate the effect of the intervention on HRQOL as it provides valid inference when data are missing at random. Because this is a pilot study, analyses will primarily be descriptive. Exploratory repeated-measures mixed-effects models will be used to evaluate longitudinal changes in outcomes and to account for within-participant correlation across study visits. All analyses will be conducted in R.

3.12.2. Analytic plan for qualitative data

Exit interviews that include questions regarding satisfaction with content, delivery, and comfort with the intervention will be conducted with intervention arm participants. Interviews will be conducted by study staff using zoom or via telephone. All recordings will transcribed using a HIPAA compliant transcription service and will be analyzed using qualitative content analysis [43].

4. Discussion

4.1. Overview of the study

Hypersensitivity Pneumonitis (HP) is an often incurable and potentially progressive fibrotic interstitial lung disease (ILD) with limited treatment options [44] that can lead to poor health-related quality of life (HRQOL). In this pilot-RCT, we will evaluate the implementation of a theory driven behavioral and educational peer-coach-led intervention to improve HRQOL in patients living with HP.

4.2. Potential limitations and proposed solutions

We anticipate that not all patients will want to participate in a behavioral intervention, or to work with a peer coach. If the RISE-HP intervention works for a proportion of individuals with HP, it will offer an opportunity to improve HRQOL for a portion of the HP patient population; this would be a substantial improvement over the current state of disease management. The mode of online administration of the intervention and data collection potentially limits the reach of the RISE-HP intervention. Internet usage is increasing in all age groups; thus, this intervention anticipates a future when lack of access to the internet is rarer than it is today. We have previously demonstrated the ability to successfully conduct research entirely remotely [18,22]. Due to the nature of the intervention, it is impossible to blind participants to their study arm assignment. Due to limited personnel in this small pilot trial, it is not feasible to blind study personnel to intervention assignment. To minimize bias, the investigators will be blinded to the block randomization generation prior to randomization, and the statistician will be blinded to assignments throughout the study and during analysis. For future larger trials, we plan to separate enrollment and data collection roles among study team members to maintain blinding to the intervention.

4.3. Innovation and impact

The study objectives align with the future vision of patient-centered outcomes research in ILD [45] by developing and piloting an intervention that will target HRQOL as a primary effectiveness outcome. We will investigate a treatment option for patients who are interested in maximizing quality of life, patients whose concerns about side effects of traditional pharmacologic therapies limits their willingness to take them, and patients open to a holistic approach to their disease management [[46], [47], [48], [49]]. Although peer support exists on the group level in ILD through support and advocacy groups, RISE-HP is the first intervention of which we are aware that will study the use of one-on-one patient peer coaches, trained to deliver a HP-specific, behavioral intervention developed with input from patients in the target population. RISE-HP meets the increasing demand by patients across the U.S. to identify helpful, trustworthy, online, disease-specific management and support resources.

CRediT authorship contribution statement

C.M. Zhang: Data curation, Investigation, Project administration, Visualization, Writing – original draft. K. Chau: Data curation, Formal analysis, Methodology, Writing – original draft, Writing – review & editing. S. Banerjee: Methodology, Writing – review & editing. J.J. Swigris: Conceptualization, Writing – review & editing. J.K. Krishnan: Conceptualization, Writing – review & editing. R.J. Kaner: Conceptualization, Writing – review & editing. F.J. Martinez: Conceptualization, Writing – review & editing. J.N. Tobin: Conceptualization, Writing – review & editing. M.M. Safford: Conceptualization, Resources, Supervision, Writing – review & editing. K.I. Aronson: Conceptualization, Funding acquisition, Investigation, Methodology, Supervision, Visualization, Writing – original draft, Writing – review & editing.

Data statement

No data were used for the research described in the article.

Funding sources

This work was supported by the NHLBI- K23HL163394; American Lung Association

Declaration of competing interests

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JKK: Reports grant funding from American Thoracic Society, COMMUNITY Center IDC, Weill Cornell DOM and center for Health Equity, American Lung Association, NHLBI, consulting and honoraria from Verona Pharma, and NACE Podcast, and medical writing for different manuscript from Novartis; RJK reports grant funding from NIH, Boehringer Ingelheim (BI), Chiesi, CSL Behring, Genentech Toray, Bellerophon, US DOD, royalty or license fees from UpToDate, consulting fees from Amgen, Genentech, Vindico, France Foundation, support for attending meetings from United Therapeutics, and BI, participation in DSMB for Puretech, Pliant, BI, Genentech, United Therapeutics, Verona Pharma, GSK, Leadership roles in the Pulmonary Wellness Foundation and Stony Wold Foundation, Stock or stock options in Doximity and Air Cycle Systems, receipt of equipment or medical writing from BI, Genentech, Galapagos, and AstraZeneca; FJM reports grants/steering committee participation with BI, Biogen, Bristol-Mysers Squibb, DevPro, GSK, Nitto, NHLBI,Roche, Vicore,Chiesi, consulting fees and honoraria from AstraZeneca (AZ),BI, Bristol-Myers Swibb, Chiesi, Endeavor, Excalibur, GSK, Lung Therapeutics/Aileron, Novartis, RS Biotherapeutics, Rejuversentx, Two XR, Hoffman Laroche, support for attending meetings from AZ, BI, Chiesi, GSK, Roche, participation in DSMB with BI, Endeavor biomedicine, and Pliant. JNT: reports grants or contracts with PCORI, NIH, Stavros Niarchos Foundation, Campbell Foundation, consulting Fees from AZ, American Diabetes Association/CVS Health, Johnson and Johnson/Janssen Pharmaceuticals, Support for attending meetings from the NIH office of the director-COMPASS program, DSMB participation through NHLBI, and leadership roles through Clinical Directors Network (CDN), AHA Professional and Public Education Committee. MMS is a member of the MESA OSMB, is the Chief Scientific Officer of MedExplain and owns stock in MedExplain. KIA reports funding from the NHLBI, Scleroderma Foundation, Stony-Wold Herbert Fund, COMMUNITY IDC fund and American Lung Association; medical writing from Genentech and Boehringer Ingelheim; honorarium for advisory board for Avalyn Pharma, Trevi Therapeutics, PureTech Health; honorarium for lectures for CME outfitters and Peer Direct; sits on the scientific review committee for the Pulmonary Fibrosis Foundation Registry and is Vice Chair of the Medical Advisory Committee for the Pulmonary Fibrosis Warriors.

Appendix A. Supplementary data

The following is the Supplementary data to this article.

Data availability

No data was used for the research described in the article.