NCT03636724

Evaluation of an E-intervention on MHBC for Chinese Cardiac Patients in Home-based Rehabilitation

Evaluation of an E-intervention on Multiple Health Behaviour Change for Chinese Cardiac Patients in Home-based Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Hong Kong Baptist University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

By using the Health Action Process Approach (HAPA) model as a theoretical backdrop, the proposed study aims to provide a 10-week e-health learning strategies for Chinese cardiac patients, with which they can follow at home after rehabilitation discharge. The current study will examine whether the cardiac rehabilitation patients in intervention group would increase their physical activity (PA) level and fruit-vegetable intake (FVI), improve the social-cognitive variables of PA and FVI, and enhance mental health outcomes in comparison with control condition; and whether the social-cognitive variables would mediate the association between intervention and adopting a healthy lifestyle. The study findings may contribute to the current multiple health behaviour intervention research and support Chinese cardiac patients to maintain rehabilitation outcomes and cultivate a healthy lifestyle.

Detailed description

For the main study, the sample size will be estimated by using G\*Power 3.1 software with MANOVA of repeated measures approach. For achieving a medium effect size of 0.25 (Duan et al., 2017), with a power (1-β) of 0.8 and an alpha of 0.05, the total sample size will be 116. Assuming a dropout rate of approximately 30%, a total of 166 participants will be required for the study evaluation. All data will be analyzed by using SPSS 23.0 software. Independent samples t-tests and Chi2-tests will be adopted to examine the characteristics of drop out and compare the differences of baseline data at T1. Statistical significance will be set at 5% level (two-tailed). The intervention effects on behavioural, social-cognitive and mental health status-related indicators will be tested by conducting the multivariate analysis of variance (MANOVA) with repeated measures, with time (T1, T2 and T3) as the with-in subjects factor and group (IG and CG) as the between-subjects factor. Missing data will be imputed within each measurement point in time using the Expectation-Maximization (EM) method. Furthermore, the intervention effect on healthy lifestyle indicator will be examined by performing a multinomial logistic regression model. The multiple-mediator model will be conducted to test the mediation effects with the use of SPSS macro (Preacher \& Hayes, 2008).

Conditions

• Cardiac Rehabilitation
• Physical Activity
• Fruit and Vegetable Intake

Interventions

Type	Name	Description
BEHAVIORAL	E-intervention	The 10-week e-health intervention will target HAPA-based social-cognitive variables of PA and FVI. Particularly, Week 1: risk perception and outcome expectancies; Week 2: goal setting; Week 3: development of action plans; Week 4: revision and adjustment of previous action plans; Week 5: development of coping plans; Week 6: revision and adjustment of previous coping plans; Week 7: development of perceived social support; Week 8: revision and adjustment of previous social support. Week 9-10: self-monitoring. Self-efficacy will be a fixed intervention variable involved from week 2 to week 10. Additionally, some behaviour change techniques will be employed in the intervention in order to facilitate the implementation and maintenance of behaviour.

Timeline

• Start date: 2021-07-31
• Primary completion: 2023-10-31
• Completion: 2023-11-30
• First posted: 2018-08-17
• Last updated: 2024-02-29

Locations

1 site across 1 country: China