Cardiovascular DiseaseseRehabNCT01223170
eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
A study testing Tailored content, Generic Internet-based information and Discussion forum in people with Cardiovascular Diseases, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Tailored content, Generic Internet-based information and Discussion forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of cardiovascular disease
- Admission to the collaborating rehabilitation center
Who cannot join
- Technological illiteracy
- Inability to access internet at home
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Cardiovascular Diseases
- Being tested
- Tailored content, Generic Internet-based information, Discussion forum, Behavioral monitoring
- Keywords
- Tailoring, Cardiac rehabilitation, Internet based intervention, Exercise, Cardiovascular Disease rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored contentBehavioural
Also called Internet based intervention
Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.
Generic Internet-based informationBehavioural
Also called Internet based intervention
Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.
Discussion forumBehavioural
Also called Internet based intervention
Access to a discussion forum for Cardiovascular Disease Rehabilitation.
Behavioral monitoringBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Internet-based intervention | Experimental | Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring Receives: Behavioral: Tailored content; Behavioral: Generic Internet-based information; Behavioral: Discussion forum; Behavioral: Behavioral monitoring |
| Control | Placebo comparator | Behavioral: Generic Internet-based information Behavioral: Discussion forum Receives: Behavioral: Generic Internet-based information; Behavioral: Discussion forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration and Intensity of Physical Activity
Measured: 1 month, 3 months and 12 months after discharge
Secondary outcomes (3)
Use of online intervention
Measured: 1 month after discharge
Use of online intervention
Measured: 3 months after discharge
Use of online intervention
Measured: 12 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startJan 2012
- Primary completionOct 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord, LHL Helse
- Responsible party
- Sponsor
- Investigators
- Silje Camilla Wangberg, PhD, Principal investigator, Kompetansesenter for Rus, Nord-Norge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223170
- Sponsor's protocol ID
- UNN-NST-eRehab-01
- Acronym
- eRehab
- Status last verified
- Dec 2014
- First submitted
- 6 Sep 2010
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22776554Antypas 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.
PubMed 24618349Antypas 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.
PubMed 24413185
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eRehab: Can Information and Communication Technology (ICT) Enhance Self-management of Cardiovascular Disease?
- ClinicalTrials.gov ID
- NCT01223170
- Acronym / sponsor ID
- eRehab / UNN-NST-eRehab-01
- Conditions
- Cardiovascular Diseases
- Keywords
- Tailoring, Cardiac rehabilitation, Internet based intervention, Exercise, Cardiovascular Disease rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Helse Nord, LHL Helse
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Internet-based intervention | Experimental | Behavioral: Tailored content, Behavioral: Generic Internet-based information, Behavioral: Discussion forum, Behavioral: Behavioral monitoringBehavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring |
| Control | Placebo comparator | Behavioral: Generic Internet-based information, Behavioral: Discussion forumBehavioral: Generic Internet-based information Behavioral: Discussion forum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of cardiovascular disease
- Admission to the collaborating rehabilitation center
Key exclusion criteria (2 listed)
- Technological illiteracy
- Inability to access internet at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored contentAlso: Internet based interventionParticipants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy. | Behavioural | Enhanced Internet-based intervention |
| Generic Internet-based informationAlso: Internet based interventionAccess to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications. | Behavioural | Control, Enhanced Internet-based intervention |
| Discussion forumAlso: Internet based interventionAccess to a discussion forum for Cardiovascular Disease Rehabilitation. | Behavioural | Control, Enhanced Internet-based intervention |
| Behavioral monitoringAlso: Internet based interventionParticipants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones. | Behavioural | Enhanced Internet-based intervention |
Primary outcome
Duration and Intensity of Physical Activity
Time frame: 1 month, 3 months and 12 months after discharge
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
- Background: PubMed 22776554Antypas 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.
- Results publication: PubMed 24618349Antypas 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.
- Derived from this study: PubMed 24413185Antypas 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.
- Norwegian Centre for Integrated Care and TelemedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silje Camilla Wangberg, PhD principal investigator
Kompetansesenter for Rus, Nord-Norge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored content, Generic Internet-based information and Discussion forum in people with Cardiovascular Diseases, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration and Intensity of Physical Activity (time frame: 1 month, 3 months and 12 months after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223170, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.