Overview

This trial is active, not recruiting.

Conditions cardiovascular diseases, heart diseases
Treatment self-regulation
Sponsor Jacobs University Bremen gGmbH
Collaborator Maastricht University
Start date September 2013
End date September 2016
Trial size 1500 participants
Trial identifier NCT01909349, EK-A-SL-022013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(No Intervention)
Control Group will gain access to the intervention after the intervention group has finished the program (>8 weeks after signing up)
(Experimental)
Self-regulation support Behavior sequence: Physical activity, then fruit & vegetable intake
self-regulation
Web-based support for behavior change regarding physical activity and fruit & vegetable consumption

Primary Outcomes

Measure
Change in dietary and physical activity behavior (self-report)
time frame: Baseline to 8 weeks later

Secondary Outcomes

Measure
Body weight
time frame: 8 weeks
BMI
time frame: 8 weeks
Days of absence from work
time frame: 8 weeks
Quality of Life
time frame: 8 weeks
Quality of Life
time frame: 3 months
Quality of Life
time frame: 6 months
Quality of Life
time frame: 12 months
Dietary and physical activity behavior (self-report)
time frame: 3 months
Dietary and physical activity behavior (self-report)
time frame: 6 months
Dietary and physical activity behavior (self-report)
time frame: 12 months
Body weight
time frame: 3 months
Body weight
time frame: 6 months
Body weight
time frame: 12 months
Days of absence from work
time frame: 3 months
Days of absence from work
time frame: 6 months
Days of absence from work
time frame: 12 months
BMI
time frame: 3 months
BMI
time frame: 6 months
BMI
time frame: 12 months

Eligibility Criteria

Male or female participants from 20 years up to 85 years old.

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.

Additional Information

Official title Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study
Principal investigator Sonia Lippke, Prof. Dr.
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?
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Jacobs University Bremen gGmbH.