Skip to main content
OpenTrials
Completed

NCT Number: NCT01223170

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skibotn Rehabilitering

Ivgobahta, Troms, 9143, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Technological illiteracy
  • Inability to access internet at home

Treatment and study plan

Tailored content

Behavioral

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

Other names: Internet based intervention

Generic Internet-based information

Behavioral

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

Other names: Internet based intervention

Discussion forum

Behavioral

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

Other names: Internet based intervention

Behavioral monitoring

Behavioral

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

Other names: Internet based intervention

Primary outcomes

  1. Duration and Intensity of Physical Activity

    Time frame: 1 month, 3 months and 12 months after discharge

Secondary outcomes

  1. Use of online intervention

    Time frame: 1 month after discharge

  2. Use of online intervention

    Time frame: 3 months after discharge

  3. Use of online intervention

    Time frame: 12 months after discharge

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Helse Nord
  • LHL Helse

Registry information

Acronym: eRehab

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 18, 2010
Registry last updated
Dec 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.