Web-based Aftercare Intervention for Cardiac Patients

Not Applicable

Completed

• Conditions: CARDIOVASCULAR DISEASES; HEART DISEASES
• Interventions: Behavioral: self-regulation

• Registration Number: NCT01909349
• Lead Sponsor: Jacobs University Bremen gGmbH

Brief Summary

Persons undergoing cardiac rehabilitation often have difficulties transferring the learned health behaviors into their daily routine which decreases their health status. Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption. The aim of this study is, to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation in Germany, the Netherlands and China. The primary goal of the study is to analyze the effectiveness of a rehabilitation aftercare program with regard to the level of physical activity and nutrition.

Detailed Description

For cardiac patients, medical rehabilitation after severe medical incidents (e.g., bypass surgery, heart attack, heart failure) is a central part in the recovery process. Health behavior change is an important subject within rehabilitation, and patients have to learn how to improve their eating habits and increase their physical activity. Back home, the adoption, maintenance and transfer into daily life of the behavior change is difficult. Until now it is unclear how such a complex behavior change actually takes place and how it can be supported effectively. On basis of theoretical assumptions (health action process approach, HAPA, Schwarzer, 1992, and compen¬satory carry-over action model, CCAM, Lippke, 2010) multiple behavior change will be observed and supported in an online intervention. To its effects, an intervention will be provided firstly targeting physical activity, secondly nutrition and compared with a waiting-list control group. Furthermore, very little is known about intercultural differences and therefore will be tested with rehabilitation patients with various cultural backgrounds. This all will be archived in the study RENATA.

RENATA is an online based intervention for post-rehabilitative medical care, with the aim to integrate skills and behavior patterns, which were gained during the rehabilitation, into daily life of the participants. The goal is to maintain learning results for a long period of time, improve rehabilitation effects at a sustained basis and support the return to the labor market i.e. to work. The objective of this research project is to increase the self-regulatory abilities of participants to the extent that they are able to be regularly and autonomously physically active and eat healthy, so that they will increase their quality of life and become resilient.

Due to the fact that there is only a limited number of evaluated programs, the present research project has the aim (1) to offer such a program and to test the effectiveness. Moreover, compared on an international level it will be considered (2) if such an aftercare program helps participants equally in different countries with rehabilitation systems varying in intensity. This question will be investigated by comparing Germany, the Netherlands and China. Due to the demographic changes, there are rising numbers of older employees in the labor market who will and should be kept in. Within this context, the last research aim is (3) to examine age effects in detail: Is it possible to determine age-specific differences in the effectiveness of the different interventions?

Study Timeline

• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Study Start: 2013-09
• Primary Completion: 2015-09
• Study Completion: 2016-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-17
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• People have Internet access
• People have sufficient knowledge of the Dutch/German language, writing and reading skills
• People have completed cardiac rehabilitation treatment or have suffered from at least one cardiac disease/event in the last 6 months
• People received behavior lifestyle recommendations with regard to physical activity and fruit and vegetable consumption

Exclusion Criteria

• People who do not want to sign the informed consent
• People with contraindications with regard to physical activity and fruit and vegetable intake
• People without Internet access
• People with insufficient abilities to use computer and Internet
• People with poor cognitive performance/dementia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group I	self-regulation	Self-regulation support Behavior sequence: Physical activity, then fruit \& vegetable intake

Primary Outcome Measures

Name	Time	Method
Change in dietary and physical activity behavior (self-report)	Baseline to 8 weeks later	change scores (mean, residual change) and percentage meeting the recommendations

Secondary Outcome Measures

Name	Time	Method
Body weight	12 months
Dietary and physical activity behavior (self-report)	12 months
Days of absence from work	12 months
Quality of Life	12 months
BMI	12 months

Trial Locations

Locations (3)

Germany; 🇩🇪 Bremen, Germany

China; 🇨🇳 Hong Kong, Hong Kong, China

The Netherlands; 🇳🇱 Maastricht, LK, Netherlands