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

H

Hong Kong Baptist University

Status

Completed

Conditions

Physical Activity
Cardiac Rehabilitation
Fruit and Vegetable Intake

Treatments

Behavioral: E-intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03636724
FRG2/17-18/099

Details and patient eligibility

About

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.

Full 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).

Enrollment

166 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • no restriction of physical mobility under the cardiac function at entry
  • no restriction of relevant diseases such as diabetes or fruit allergies
  • As the study involves an online website and mobile phone SMS, only participants with access to the Internet via mobile phone will be enrolled

Exclusion criteria

  • have restrictions of physical mobility under the cardiac function at entry
  • have restrictions of relevant diseases such as diabetes or fruit allergies
  • cannot use the Internet and mobile phone

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

166 participants in 2 patient groups

Intervention group
Experimental group
Description:
Patients will receive the interventions on both PA and FVI simultaneously.
Treatment:
Behavioral: E-intervention
Waiting control group
No Intervention group
Description:
Patients will not receive any supportive interventions on PA or FVI during the intervention period but will be provided with the same intervention at follow-up six-month after the intervention.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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