An interventional study of Tailored content and Generic Internet-based information in Cardiovascular Diseases, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Supportive care
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:
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
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 69 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University Hospital of North Norway is the lead sponsor of 150 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring
Behavioral: Tailored content · Behavioral: Generic Internet-based information · Behavioral: Discussion forum · Behavioral: Behavioral monitoring
Behavioral: Generic Internet-based information Behavioral: Discussion forum
Behavioral: Generic Internet-based information · Behavioral: Discussion forum
Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.
Also known as: Internet based intervention
Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.
Also known as: Internet based intervention
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Also known as: Internet based intervention
Participants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones.
Also known as: Internet based intervention
Duration and Intensity of Physical Activity
Time frame: 1 month, 3 months and 12 months after discharge
Use of online intervention
Time frame: 1 month after discharge
Use of online intervention
Time frame: 3 months after discharge
Use of online intervention
Time frame: 12 months after discharge
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital of North Norway