- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01223170
eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease? (eRehab)
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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Troms
-
Skibotn, Troms, Norway, 9143
- Skibotn Rehabilitering
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of cardiovascular disease
- Admission to the collaborating rehabilitation center
Exclusion Criteria:
- Technological illiteracy
- Inability to access internet at home
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Internet-based intervention
Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring
|
Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.
Other Names:
Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.
Other Names:
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Other Names:
Participants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones.
Other Names:
|
Placebo Comparator: Control
Behavioral: Generic Internet-based information Behavioral: Discussion forum
|
Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.
Other Names:
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration and Intensity of Physical Activity
Time Frame: 1 month, 3 months and 12 months after discharge
|
1 month, 3 months and 12 months after discharge
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of online intervention
Time Frame: 1 month after discharge
|
1 month after discharge
|
Use of online intervention
Time Frame: 3 months after discharge
|
3 months after discharge
|
Use of online intervention
Time Frame: 12 months after discharge
|
12 months after discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Silje Camilla Wangberg, PhD, Kompetansesenter for Rus, Nord-Norge
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNN-NST-eRehab-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
-
Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
-
Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
-
Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Tailored content
-
Hackensack Meridian HealthRecruiting
-
University of MichiganCompletedSubstance UseUnited States
-
Uppsala University HospitalHaukeland University Hospital; University Hospital, Linkoeping; Smerud Medical...UnknownIGA NephropathyNorway, Sweden
-
University of WashingtonNational Institute of Mental Health (NIMH); Mental Health America; TalkspaceRecruiting
-
Evidation HealthBiomedical Advanced Research and Development AuthorityEnrolling by invitationCOVID-19 | Influenza | Influenza A | Respiratory Syncytial Virus (RSV) | Influenza BUnited States
-
Stanford UniversityWithdrawn
-
Baylor College of MedicineAgency for Healthcare Research and Quality (AHRQ)CompletedPrimary Care Patients With Chronic Conditions
-
Abramson Cancer Center at Penn MedicineUniversity of FloridaRecruitingCommunication Research | Adolescent Behavior | VapingUnited States
-
National University, SingaporeJaedye LabsCompletedStress | BurnoutSingapore
-
University of Alabama at BirminghamNot yet recruitingFatigue | Physical Activity | Self Efficacy | Disability Physical | eHealth | Health Literacy | Behavior, Health | Usability | Mobility Limitations | Predictive Model | Telehealth | Health CoachingUnited States