Improving physical and psychological outcomes of cardiac patients using the Naluri app: A study protocol for a randomized controlled trial

Abstract

Background: Coronary artery disease (CAD) continues to be a significant burden to public health. Poor treatment and management can lead to more severe cardiac events that could result in death or disability. Early interventions like cardiac rehabilitation programs can provide patients the required knowledge, skills and support to recover from and prevent more cardiac events. Electronic health (eHealth) interventions have potential to complement hospital-based rehabilitation programs. This study aims to investigate the effectiveness of the Naluri app in improving health behaviours, clinical and psychological outcomes in a sample of cardiac patients in Malaysia. Methods: This study is a two-arm, parallel, superiority randomized control trial to be conducted at the Malaysian National Heart Institute. A total of 200 patients will be randomly assigned to either a 16-week theory-based Naluri app in addition to usual care (treatment) or to usual care only (control). Outcomes will be measured at baseline and at 16 weeks. Health behaviour outcomes include physical activity and diet. Clinical outcomes include BMI, hemoglobin A1c (HbA1c), and lipid levels. Psychological outcomes include anxiety, depression, and health related quality of life (HRQOL). The Naluri app theoretical framework is based on the Health Action Process Approach (HAPA) theory. Risk perception, self-efficacy, planning, intentions, outcome expectancies, illness perceptions and psychological outcomes will be measured using self-reported measures. Discussion: This trial will determine the effectiveness of the Naluri app intervention in improving various outcomes of cardiac patients after four months. It will provide data on the applicability of the HAPA theory in Mobile health (mHealth) intervention and the acceptance and efficacy of mHealth as a cardiac rehabilitation program for patients in Malaysia. The results may inform the potential implementation of the app for use with patients with other chronic illnesses like diabetes, stroke, and depression. Registration: Australia New Zealand Clinical Trials Registry (14/01/2019, ACTRN12619000104156).