Web-based Aftercare Intervention for Cardiac Patients

CARDIOVASCULAR DISEASES Clinical Trial

— RENATA  

Official title:

Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909349
• Other study ID #: EK-A-SL-022013
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: April 17, 2017
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Jacobs University Bremen gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: August 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• CARDIOVASCULAR DISEASES
• Heart Diseases

Intervention

Behavioral:
• self-regulation
Web-based support for behavior change regarding physical activity and fruit & vegetable consumption

Locations

Country	Name	City	State
China	China	Hong Kong	Hong Kong
Germany	Germany	Bremen
Netherlands	The Netherlands	Maastricht	LK

Sponsors (5)

Lead Sponsor	Collaborator
Jacobs University Bremen gGmbH	Guangdong General Hospital, Hong Kong Baptist University, Institute of Physical Education and Sports Sciences, Maastricht University

Countries where clinical trial is conducted

China,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in dietary and physical activity behavior (self-report)	change scores (mean, residual change) and percentage meeting the recommendations	Baseline to 8 weeks later
Secondary	Body weight		8 weeks
Secondary	BMI		8 weeks
Secondary	Days of absence from work		8 weeks
Secondary	Quality of Life		8 weeks
Secondary	Quality of Life		3 months
Secondary	Quality of Life		6 months
Secondary	Quality of Life		12 months
Secondary	Dietary and physical activity behavior (self-report)		3 months
Secondary	Dietary and physical activity behavior (self-report)		6 months
Secondary	Dietary and physical activity behavior (self-report)		12 months
Secondary	Body weight		3 months
Secondary	Body weight		6 months
Secondary	Body weight		12 months
Secondary	Days of absence from work		3 months
Secondary	Days of absence from work		6 months
Secondary	Days of absence from work		12 months
Secondary	BMI		3 months
Secondary	BMI		6 months
Secondary	BMI		12 months