Cost effectiveness and functional outcomes of smartphone cardiac rehabilitation assisted self-management versus centre based cardiac rehabilitation among patients with coronary heart disease in Southern India: a multicentre randomized clinical trial protocol

Abstract

Background: To attain the world specific indicators of quality on programs which brings rehabilitation for cardiac diseases and surgeries in India are to be brought to meet the international standards. Dearth of published research on cost effectiveness of smart phone application oriented CR assisted self-management (SCRAM) over centre based (CBCR) in Indian Population drives this study to be done. This study aims to analyze cost effectiveness of SCRAM versus CBCR in coronary artery disease (CAD) patients. Methods: In this multicentre randomized clinical trial, 100 subjects with uncomplicated CAD will be recruited through purposive sampling and divided into group A and B through block randomization. Group A will be treated with CBCR whereas group B with SCRAM. Outcome measures of 6 minutes’ walk test distance, talk test values and SF 36 scores, high density lipoprotein level and 3 months’ average blood glucose level were documented pre and post interventions and 3, 6, 12 months follow up for data analysis. This study will follow human study ethical consideration based on Declaration of Helsinki. Conclusions: Cost effectiveness of experimental group where SCRAM given as intervention may be better post intervention than control group where CBCR given. By this way this RCT protocol may bring the execution cost down with coronary heart disease patients which play a major role in participation of these patients in CR programs. Trial registration: The trial was registered with CTRI – Clinical Trial Registry of India (ICMR) - CTRI/2022/11/047143 (registered on: 09 November 2022) - trial registered prospectively.