Trial record 5 of 7723 for:    Open Studies | "Cardiovascular Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital of North Norway
Sponsor:
Collaborators:
Helse Nord
LHL Helse
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01223170
First received: September 6, 2010
Last updated: November 4, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Cardiovascular Diseases
Behavioral: Tailored content
Behavioral: Generic Internet-based information
Behavioral: Discussion forum
Behavioral: Behavioral monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Duration and Intensity of Physical Activity [ Time Frame: 1 month, 3 months and 12 months after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of online intervention [ Time Frame: 1 month after discharge ] [ Designated as safety issue: No ]
  • Use of online intervention [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
  • Use of online intervention [ Time Frame: 12 months after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 255
Study Start Date: September 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Internet-based intervention
Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring
Behavioral: Tailored content
Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.
Other Name: Internet based intervention
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.
Other Name: Internet based intervention
Behavioral: Discussion forum
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Other Name: Internet based intervention
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.
Other Name: Internet based intervention
Placebo Comparator: Control
Behavioral: Generic Internet-based information Behavioral: Discussion forum
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.
Other Name: Internet based intervention
Behavioral: Discussion forum
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Other Name: Internet based intervention

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Technological illiteracy
  • Inability to access internet at home
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223170

Contacts
Contact: Konstantinos Antypas, MSc +4797613265 Konstantinos.Antypas@telemed.no

Locations
Norway
Skibotn Rehabilitering Recruiting
Skibotn, Troms, Norway, 9143
Contact: Hanne Hoaas    +4777715900    Hanne.Hoaas@skibotnsenteret.no   
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
LHL Helse
Investigators
Principal Investigator: Silje Camilla Wangberg, PhD Kompetansesenter for Rus, Nord-Norge
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01223170     History of Changes
Other Study ID Numbers: UNN-NST-eRehab-01
Study First Received: September 6, 2010
Last Updated: November 4, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by University Hospital of North Norway:
Tailoring
Cardiac rehabilitation
Internet based intervention
Exercise
Cardiovascular Disease rehabilitation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014