CClinicalTrials.gg
CompletedNCT01909349RENATAUpdated Apr 19, 2017

Web-based Aftercare Intervention for Cardiac Patients

An interventional study of self-regulation in CARDIOVASCULAR DISEASES and HEART DISEASES, sponsored by Jacobs University Bremen gGmbH. Completed at 3 sites in 3 countries. Open to participants aged 20 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-19.

Sponsored by Jacobs University Bremen gGmbH · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

Read the 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?

02

Conditions studied

  • CARDIOVASCULAR DISEASES
  • HEART DISEASES

Keywords

  • medical rehabilitation
  • aftercare
  • multiple health behavior change
  • diet
  • physical activity
  • computer
  • international study
  • ETHNOPSYCHOLOGY
  • HABIT
  • HEALTH
  • eHealth
  • eLearning
03

In context

Cardiovascular Diseases

4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 1,000 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Jacobs University Bremen gGmbH is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,000 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralself-regulation

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

06

What researchers measure

Primary outcomes

  1. Change in dietary and physical activity behavior (self-report)

    change scores (mean, residual change) and percentage meeting the recommendations

    Time frame: Baseline to 8 weeks later

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

07

Study locations

3 sites
  • China
    Hong Kong, Hong Kong, China
  • Germany
    Bremen, 28759, Germany
  • The Netherlands
    Maastricht, LK 6211, Netherlands
08

References and documents

Publications

  • Duan YP, Liang W, Guo L, Wienert J, Si GY, Lippke S. Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial. J Med Internet Res. 2018 Nov 19;20(11):e12052. doi: 10.2196/12052. PubMed 30455167 ↗
  • Storm V, Reinwand DA, Wienert J, Tan SL, Lippke S. The Mediating Role of Perceived Social Support Between Physical Activity Habit Strength and Depressive Symptoms in People Seeking to Decrease Their Cardiovascular Risk: Cross-Sectional Study. JMIR Ment Health. 2018 Nov 14;5(4):e11124. doi: 10.2196/11124. PubMed 30429112 ↗
  • Tan SL, Storm V, Reinwand DA, Wienert J, de Vries H, Lippke S. Understanding the Positive Associations of Sleep, Physical Activity, Fruit and Vegetable Intake as Predictors of Quality of Life and Subjective Health Across Age Groups: A Theory Based, Cross-Sectional Web-Based Study. Front Psychol. 2018 Jun 18;9:977. doi: 10.3389/fpsyg.2018.00977. eCollection 2018. PubMed 29967588 ↗
  • Duan YP, Wienert J, Hu C, Si GY, Lippke S. Web-Based Intervention for Physical Activity and Fruit and Vegetable Intake Among Chinese University Students: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e106. doi: 10.2196/jmir.7152. PubMed 28396306 ↗
  • Kuhlmann T, Reips UD, Wienert J, Lippke S. Using Visual Analogue Scales in eHealth: Non-Response Effects in a Lifestyle Intervention. J Med Internet Res. 2016 Jun 22;18(6):e126. doi: 10.2196/jmir.5271. PubMed 27334562 ↗
  • Storm V, Dorenkamper J, Reinwand DA, Wienert J, De Vries H, Lippke S. Effectiveness of a Web-Based Computer-Tailored Multiple-Lifestyle Intervention for People Interested in Reducing their Cardiovascular Risk: A Randomized Controlled Trial. J Med Internet Res. 2016 Apr 11;18(4):e78. doi: 10.2196/jmir.5147. PubMed 27068880 ↗
  • Reinwand DA, Crutzen R, Storm V, Wienert J, Kuhlmann T, de Vries H, Lippke S. Generating and predicting high quality action plans to facilitate physical activity and fruit and vegetable consumption: results from an experimental arm of a randomised controlled trial. BMC Public Health. 2016 Apr 12;16:317. doi: 10.1186/s12889-016-2975-3. PubMed 27066779 ↗
  • Reinwand D, Kuhlmann T, Wienert J, de Vries H, Lippke S. Designing a theory- and evidence-based tailored eHealth rehabilitation aftercare program in Germany and the Netherlands: study protocol. BMC Public Health. 2013 Nov 19;13:1081. doi: 10.1186/1471-2458-13-1081. PubMed 24245493 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01909349
Lead sponsor
Jacobs University Bremen gGmbH
Collaborators
Maastricht University, Institute of Physical Education and Sports Sciences, Guangdong Provincial People's Hospital, Hong Kong Baptist University
Responsible party
Prof. Dr. Sonia Lippke (Professor of Health Psychology, Jacobs University Bremen gGmbH) — Principal investigator
First posted
Jul 26, 2013
Start date
Sep 2013
Primary completion
Sep 2015
Completion
Aug 2016
Last update
Apr 19, 2017

Study contacts

Sonia Lippke, Prof. Dr.
principal investigator · Jacobs University Bremen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion