CTRI/2020/11/028808.
| Study name | A factorial randomized trial of structured physical activity training and brief cognitive behavioural therapy for prevention of repeat hospital admission and death among acute decompensated heart failure patients |
| Methods |
Study design: RCT Country: India |
| Participants | Acute decompensated heart failure patients Inclusion criteria: a. age more than or equal to 18 years; b. citizen of India, who is a permanent resident of Kerala; c. heart failure patients as defined in ESC 2016. Exclusion criteria: a. refused to provide consent; b. enrolled in other cardiac rehabilitation programmes; c. bedridden. Stated purpose: to see if rehabilitation strategies of structured physical activity and brief cognitive behavioural therapy for depression and self‐management reduces the risk of repeat hospitalization and death in heart failure patients |
| Interventions |
Intervention: PACT‐HF. A 2‐by‐2 factorial trial for structured physical activity and brief cognitive behaviour therapy for heart failure patients A structured exercise‐training programme and a brief cognitive behaviour therapy will be delivered by a non‐physician health worker. The health worker will be trained to deliver exercise and face‐to‐face CBT sessions for people reporting in outpatient settings of the hospital. The intervention will be given three times during the first three months and thereafter once in every three months. Control: No intervention |
| Outcomes |
Participants' outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (24 months) |
| Starting date | 1 December 2020 (first enrolment) |
| Contact information | Dr Harikrishnan S, drharikrishnan@outlook.com |
| Notes |
Source of funding: Indian Council of Medical Research, Ansari Nagar, New Delhi, India ‐ 110029 Prospective trial registration number: CTRI/2020/11/028808 |