Web-based Aftercare Intervention for Cardiac Patients (RENATA)

April 17, 2017 updated by: Prof. Dr. Sonia Lippke, Jacobs University Bremen gGmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • China
  • Germany
      • Bremen, Germany, 28759
        • Germany
  • Netherlands
    • LK
      • Maastricht, LK, Netherlands, 6211
        • The Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Control Group will gain access to the intervention after the intervention group has finished the program (>8 weeks after signing up)
Experimental: Intervention Group I
Self-regulation support Behavior sequence: Physical activity, then fruit & vegetable intake
Behavioral: self-regulation
Web-based support for behavior change regarding physical activity and fruit & vegetable consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in dietary and physical activity behavior (self-report)
Time Frame: Baseline to 8 weeks later
change scores (mean, residual change) and percentage meeting the recommendations
Baseline to 8 weeks later

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jacobs University Bremen gGmbH

Collaborators

Guangdong Provincial People's Hospital
Maastricht University
Hong Kong Baptist University
Institute of Physical Education and Sports Sciences

Investigators

  • Principal Investigator: Sonia Lippke, Prof. Dr., Jacobs University Bremen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-A-SL-022013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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