eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?

Study Overview
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Brief Summary
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Cardiovascular Diseases (CVD) according to the World Health Organization (WHO) are leading causes of death and represent 30% of all global deaths and 48% of the deaths in Europe. Moreover, the current trends predict increase in deaths caused by Cardiovascular Diseases over the next years. Secondary preventive efforts can decrease mortality risk as well as improve health among Cardiovascular Disease patients. This study suggests an innovative approach in supporting the self-management of Cardiovascular Disease patients after rehabilitation. The implied Randomized Controlled Trial has two arms and aims to investigate the effectiveness of tailoring in an Information and Communication Technology (ICT) based intervention. The tailoring will be based on concepts derived from health psychology theories, and will contribute in their further development. More specifically: Aim 1: To assess the needs of CVD rehabilitation patients that can potentially be met through the use of ICT. Aim 2: To assess the effects of a tailored Internet-based intervention on maintenance of self-management behaviors after a rehabilitation stay. Hypothesis: The intervention group (tailored) will have higher adherence a) to the Internet-based intervention, and b) to self-management. Aim 3: To assess the effect of mobile technology with activity sensors on physical activity. Hypothesis: There will be a relationship between the data collected from activity sensors and the self-reported physical activity levels.

Detailed Description
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A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample

Official Title
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eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Tailored content
* Behavioral: Generic Internet-based information
* Behavioral: Discussion forum
* Behavioral: Behavioral monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of cardiovascular disease Admission to the collaborating rehabilitation center Exclusion Criteria: Technological illiteracy Inability to access internet at home

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Internet-based intervention<br>Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring | Behavioral: Tailored content<br>* Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.<br>* Other names: Internet based intervention;Behavioral: Generic Internet-based information<br>* Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.<br>* Other names: Internet based intervention;Behavioral: Discussion forum<br>* Access to a discussion forum for Cardiovascular Disease Rehabilitation.<br>* Other names: Internet based intervention;Behavioral: Behavioral monitoring<br>* Participants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones.<br>* Other names: Internet based intervention;|
| Placebo Comparator: Control<br>Behavioral: Generic Internet-based information Behavioral: Discussion forum | Behavioral: Generic Internet-based information<br>* Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.<br>* Other names: Internet based intervention;Behavioral: Discussion forum<br>* Access to a discussion forum for Cardiovascular Disease Rehabilitation.<br>* Other names: Internet based intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration and Intensity of Physical Activity |  | 1 month, 3 months and 12 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of online intervention |  | 1 month after discharge | 
| Use of online intervention |  | 3 months after discharge | 
| Use of online intervention |  | 12 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tailoring, Cardiac rehabilitation, Internet based intervention, Exercise, Cardiovascular Disease rehabilitation