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CARDIOVASCULAR DISEASESRENATANCT01909349

Web-based Aftercare Intervention for Cardiac Patients

A study testing self-regulation in people with CARDIOVASCULAR DISEASES and HEART DISEASES, run by Jacobs University Bremen gGmbH at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for
CARDIOVASCULAR DISEASES, HEART DISEASES
What is being tested?
self-regulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
3 sitesin 3 countries
Study dates
Sep 2013to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

China1 site

  • China

    Hong Kong, Hong Kong

Other trials in China

Germany1 site

  • Germany

    Bremen, Free Hanseatic City of Bremen, 28759

Other trials in Germany

Netherlands1 site

  • The Netherlands

    Maastricht, LK, 6211

Other trials in Netherlands

About this study

Official title: 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.

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?

Being tested
self-regulation
Keywords
medical rehabilitation, aftercare, multiple health behavior change, diet, physical activity, computer, international study, ETHNOPSYCHOLOGY, HABIT, HEALTH, eHealth, eLearning
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Motor Activity, Habits

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • self-regulationBehavioural

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

Study groups in NCT01909349
Study groupRoleWhat they receive
Control GroupNo interventionControl Group will gain access to the intervention after the intervention group has finished the program (>8 weeks after signing up)
Intervention Group IExperimentalSelf-regulation support Behavior sequence: Physical activity, then fruit \& vegetable intake
Receives: Behavioral: self-regulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline to 8 weeks later

Secondary outcomes (19)

  1. Body weight

    Measured: 8 weeks

  2. BMI

    Measured: 8 weeks

  3. Days of absence from work

    Measured: 8 weeks

  4. Quality of Life

    Measured: 8 weeks

  5. Quality of Life

    Measured: 3 months

  6. Quality of Life

    Measured: 6 months

  7. Quality of Life

    Measured: 12 months

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

    Measured: 3 months

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

    Measured: 6 months

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

    Measured: 12 months

  11. Body weight

    Measured: 3 months

  12. Body weight

    Measured: 6 months

  13. Body weight

    Measured: 12 months

  14. Days of absence from work

    Measured: 3 months

  15. Days of absence from work

    Measured: 6 months

  16. Days of absence from work

    Measured: 12 months

  17. BMI

    Measured: 3 months

  18. BMI

    Measured: 6 months

  19. BMI

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2015
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01909349
Sponsor's protocol ID
EK-A-SL-022013
Acronym
RENATA
Status last verified
Apr 2017
First submitted
17 Jul 2013
Last updated
19 Apr 2017
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A study testing self-regulation in people with CARDIOVASCULAR DISEASES and HEART DISEASES, run by Jacobs University Bremen gGmbH at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dietary and physical activity behavior (self-report) (time frame: Baseline to 8 weeks later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01909349, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.

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