Clinical trial NCT01909349: Web-based Aftercare Intervention for Cardiac Patients
Official title: Rehabiliation-Aftercare for an Optimal Transfer Into Autonomous Daily Life (RENATA) - an eHealth Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CARDIOVASCULAR DISEASES
HEART DISEASES
Keywords: medical rehabilitation
aftercare
multiple health behavior change
diet
physical activity
computer
international study
ETHNOPSYCHOLOGY
HABIT
HEALTH
eHealth
eLearning
Lead sponsor: Jacobs University Bremen gGmbH
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Institute of Physical Education and Sports Sciences
name: Guangdong Provincial People's Hospital
name: Hong Kong Baptist University
First posted: 2013-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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?

Eligibility criteria: 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.

Primary outcomes:
measure: Change in dietary and physical activity behavior (self-report)
timeFrame: Baseline to 8 weeks later
Secondary outcomes:
measure: Body weight
timeFrame: 8 weeks
measure: BMI
timeFrame: 8 weeks
measure: Days of absence from work
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 8 weeks
measure: Quality of Life
timeFrame: 3 months
measure: Quality of Life
timeFrame: 6 months
measure: Quality of Life
timeFrame: 12 months
measure: Dietary and physical activity behavior (self-report)
timeFrame: 3 months
measure: Dietary and physical activity behavior (self-report)
timeFrame: 6 months
measure: Dietary and physical activity behavior (self-report)
timeFrame: 12 months
measure: Body weight
timeFrame: 3 months
measure: Body weight
timeFrame: 6 months
measure: Body weight
timeFrame: 12 months
measure: Days of absence from work
timeFrame: 3 months
measure: Days of absence from work
timeFrame: 6 months
measure: Days of absence from work
timeFrame: 12 months
measure: BMI
timeFrame: 3 months
measure: BMI
timeFrame: 6 months
measure: BMI
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: China
state: Hong Kong
city: Bremen
country: Germany
facility: Germany
city: Maastricht
country: Netherlands
facility: The Netherlands
state: LK
Study officials:
affiliation: Jacobs University Bremen
name: Sonia Lippke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.