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

NCT ID: NCT01223170

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

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

Conditions

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Cardiovascular Diseases

Keywords

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Tailoring Cardiac rehabilitation Internet based intervention Exercise Cardiovascular Disease rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Enhanced Internet-based intervention

Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring

Group Type EXPERIMENTAL

Tailored content

Intervention Type BEHAVIORAL

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

Generic Internet-based information

Intervention Type BEHAVIORAL

Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.

Discussion forum

Intervention Type BEHAVIORAL

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

Behavioral monitoring

Intervention Type BEHAVIORAL

Participants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones.

Control

Behavioral: Generic Internet-based information Behavioral: Discussion forum

Group Type PLACEBO_COMPARATOR

Generic Internet-based information

Intervention Type BEHAVIORAL

Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.

Discussion forum

Intervention Type BEHAVIORAL

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

Interventions

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Tailored content

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Discussion forum

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Internet based intervention Internet based intervention Internet based intervention Internet based intervention

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Nord

INDUSTRY

Sponsor Role collaborator

LHL Helse

OTHER

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silje Camilla Wangberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Kompetansesenter for Rus, Nord-Norge

Locations

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Skibotn Rehabilitering

Ivgobahta, Troms, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 22776554 (View on PubMed)

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: 10.2196/jmir.3132.

Reference Type RESULT
PMID: 24618349 (View on PubMed)

Antypas K, Wangberg SC. Combining users' needs with health behavior models in designing an internet- and mobile-based intervention for physical activity in cardiac rehabilitation. JMIR Res Protoc. 2014 Jan 10;3(1):e4. doi: 10.2196/resprot.2725.

Reference Type DERIVED
PMID: 24413185 (View on PubMed)

Related Links

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http://www.telemed.no

Norwegian Centre for Integrated Care and Telemedicine

Other Identifiers

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UNN-NST-eRehab-01

Identifier Type: -

Identifier Source: org_study_id