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

Cardiovascular Diseases Clinical Trial

— eRehab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223170
• Other study ID #: UNN-NST-eRehab-01
• Status: Completed
• Phase: N/A
• First received: September 6, 2010
• Last updated: December 11, 2014
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of cardiovascular disease

• Admission to the collaborating rehabilitation center

Exclusion Criteria:

• Technological illiteracy

• Inability to access internet at home

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
Norway	Skibotn Rehabilitering	Skibotn	Troms

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital of North Norway	Helse Nord, LHL Helse

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Antypas K, Wangberg SC. An Internet- and mobile-based tailored intervention to enhance maintenance of physical activity after cardiac rehabilitation: short-term results of a randomized controlled trial. J Med Internet Res. 2014 Mar 11;16(3):e77. doi: 10.2 — View Citation

Antypas K, Wangberg SC. E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial. BMC Cardiovasc Disord. 2012 Jul 9;12:50. doi: 10.1186/1471-2261-12-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration and Intensity of Physical Activity		1 month, 3 months and 12 months after discharge	No
Secondary	Use of online intervention		1 month after discharge	No
Secondary	Use of online intervention		3 months after discharge	No
Secondary	Use of online intervention		12 months after discharge	No

External Links

•   Intervention website
•   Norwegian Centre for Integrated Care and Telemedicine
•   Skibotn Rehabilitation Centre