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Completed

NCT Number: NCT01909349

Web-based Aftercare Intervention for Cardiac Patients

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China, Hong Kong

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About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

self-regulation

Behavioral

Web-based support for behavior change regarding physical activity and fruit & vegetable consumption

Primary outcomes

  1. 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

Secondary outcomes

  1. Body weight

    Time frame: 8 weeks

  2. BMI

    Time frame: 8 weeks

  3. Days of absence from work

    Time frame: 8 weeks

  4. Quality of Life

    Time frame: 8 weeks

  5. Quality of Life

    Time frame: 3 months

  6. Quality of Life

    Time frame: 6 months

  7. Quality of Life

    Time frame: 12 months

  8. Dietary and physical activity behavior (self-report)

    Time frame: 3 months

  9. Dietary and physical activity behavior (self-report)

    Time frame: 6 months

  10. Dietary and physical activity behavior (self-report)

    Time frame: 12 months

  11. Body weight

    Time frame: 3 months

  12. Body weight

    Time frame: 6 months

  13. Body weight

    Time frame: 12 months

  14. Days of absence from work

    Time frame: 3 months

  15. Days of absence from work

    Time frame: 6 months

  16. Days of absence from work

    Time frame: 12 months

  17. BMI

    Time frame: 3 months

  18. BMI

    Time frame: 6 months

  19. BMI

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Jacobs University Bremen gGmbH

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RENATA

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 26, 2013
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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