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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01223170
Acronym
eRehab
Enrollment
69
Registered
2010-10-18
Start date
2012-01-31
Completion date
2014-12-31
Last updated
2014-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Tailoring, Cardiac rehabilitation, Internet based intervention, Exercise, Cardiovascular Disease rehabilitation

Brief 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.

Detailed 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

Interventions

BEHAVIORALTailored content

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

BEHAVIORALGeneric Internet-based information

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

BEHAVIORALDiscussion forum

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

BEHAVIORALBehavioral monitoring

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

Sponsors

Helse Nord
CollaboratorINDUSTRY
LHL Helse
CollaboratorOTHER
University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* History of cardiovascular disease * Admission to the collaborating rehabilitation center

Exclusion criteria

* Technological illiteracy * Inability to access internet at home

Design outcomes

Primary

MeasureTime frame
Duration and Intensity of Physical Activity1 month, 3 months and 12 months after discharge

Secondary

MeasureTime frame
Use of online intervention1 month after discharge

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026