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

This study is currently recruiting participants.

Verified February 2012 by University Hospital of North Norway

Sponsor:

Collaborators:

Helse Nord

Skibotnsenteret

Information provided by (Responsible Party):

University Hospital of North Norway

ClinicalTrials.gov Identifier:

NCT01223170

First received: September 6, 2010

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Purpose

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.

Condition	Intervention
Cardiovascular Diseases	Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:

Duration and Intensity of Physical Activity [ Time Frame: 1 month after discharge ] [ Designated as safety issue: No ]
Duration and Intensity of Physical Activity [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
Duration and Intensity of Physical Activity [ Time Frame: 12 months after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Use of online intervention [ Time Frame: 1 month after discharge ] [ Designated as safety issue: No ]
Use of online intervention [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
Use of online intervention [ Time Frame: 12 months after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment:	255
Study Start Date:	September 2011
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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

Arms

Assigned Interventions

Experimental: Enhanced Internet-based intervention

Behavioral: Tailored content

Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.