Prabhakaran 2019.
Study characteristics | |
Methods |
Study design: cluster‐RCT Duration of study: the study was conducted from 2016 to 2017. Country: Haryana (North India) and Karnataka (South India) Income classification: low‐middle‐income country from 2007 Geographical scope: rural Healthcare setting: 20 community health centres |
Participants | 1. Age: 55.1 ± 11.0 years 2. Gender: both 3. Socioeconomic background: 27.1% were employed. 4. Educational background: 42.9% had higher than primary school education. Inclusion criteria Participants: a. were ≥ 30 years of age; b. intended to reside in the catchment area of CHCs for ≥ 1 year; c. had been diagnosed with hypertension with systolic blood pressure (SBP) ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg or type 2 diabetes mellitus with fasting blood glucose ≥ 140 mg/dL or postprandial blood glucose ≥ 200 mg/dL. Exclusion criteria: a. pregnant women, patients with type 1 diabetes mellitus, patients requiring immediate referral to tertiary care because of accelerated hypertension or diabetic complications; b. patients with learning difficulties or vision or hearing impairments; c. patients with malignancy or other life‐threatening conditions. Note: considerations on baseline scores not applicable for this study Stated purpose: to assess the impact of the mWellcare system on mental health status in patients with hypertension and diabetes |
Interventions |
Name: mWellcare system Title/name of PW and number: physicians, nurses 1. Selection: not specified 2. Educational background: not specified 3. Training: it provided centralized training on the current clinical management guidelines to all physicians. For NCD nurses, it provided training in the management of hypertension, diabetes mellitus, depression, and tobacco and alcohol use. In addition, 3 days of training were provided to nurses on using the mWellcare system. 4. Supervision: the training was supplemented by another 2 days of onsite supervision and support. They conducted a rigorous process evaluation in the trial. Trained research staff using a structured observation checklist conducted periodic monitoring visits of trial sites to assess the fidelity of the intervention (by staff). 5. Incentives/remuneration: not specified Prevention type: selective—participants were included based upon the presence of a risk factor (chronic condition: hypertension or diabetes). Intervention details: the mWellcare system was an Android application built on the CommCare platform. The mWellcare system was designed to generate EDS recommendations for the management of hypertension and diabetes mellitus, comorbid depression, and alcohol and tobacco use, tailored to the participant’s profile and risk level. It stored the health records electronically, enabling long‐term monitoring and follow‐up. It was also equipped to send short message service reminders (to take medication and attend follow‐up visits) to patients. In the mWellcare arm, the NCD nurse used a tablet computer installed with the mWellcare system to collect data on patient history, blood pressure, blood glucose, depression, tobacco and alcohol use, and current medications. From this patient‐specific clinical information, the mWellcare system generated a decision support recommendation (DSR) for the physician. The DSR printout summarized information on patient profile, diagnosed condition, comorbid conditions, and previous and current medications and recommended a treatment plan for the 5 chronic conditions based on standard guidelines. The DSR also provided a lifestyle modification advisory and date for the next follow‐up visit. Control: usual care – in the control group, they provided training to physicians on the clinical management guidelines for hypertension and diabetes mellitus. In addition, as with the mWellcare arm, charts on the management of these conditions were displayed prominently at the outpatient clinics. They also conducted the NCD nurses’ training in the management of hypertension and diabetes mellitus. To balance both study arms, they provided the EUC NCD nurses with a tablet computer (without the mWellcare system) for collecting data at the baseline visit. |
Outcomes |
Participants’outcomes of interest for this review
Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points: baseline, post‐intervention (< 1 month) Note: data were not included in the meta‐analysis because they were not provided in the right format or were not available even after attempted author contact. |
Notes |
Source of funding: this research study was supported by the Wellcome Trust (grant 096735/A/11/Z). The funding source had no role in the design of this study; during the execution,
analyses, and interpretation of data; or in the decision to submit results. Notes on validation of instruments (screening and outcomes): the PHQ‐9 is a widely established and validated tool. Additional information: none Handling the data: the online‐only Data Supplement is available with this article at www.ahajournals.org/doi/suppl/10.1161/circulationaha.118.038192. Prospective trial registration number: NCT02480062 |