NCT01223170

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

September 6, 2010

Last Update Submit

December 11, 2014

Conditions

Keywords

TailoringCardiac rehabilitationInternet based interventionExerciseCardiovascular Disease rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Duration and Intensity of Physical Activity

    1 month, 3 months and 12 months after discharge

Secondary Outcomes (3)

  • Use of online intervention

    1 month after discharge

  • Use of online intervention

    3 months after discharge

  • Use of online intervention

    12 months after discharge

Study Arms (2)

Enhanced Internet-based intervention

EXPERIMENTAL

Behavioral: Tailored content Behavioral: Generic Internet-based information Behavioral: Discussion forum Behavioral: Behavioral monitoring

Behavioral: Tailored contentBehavioral: Generic Internet-based informationBehavioral: Discussion forumBehavioral: Behavioral monitoring

Control

PLACEBO COMPARATOR

Behavioral: Generic Internet-based information Behavioral: Discussion forum

Behavioral: Generic Internet-based informationBehavioral: Discussion forum

Interventions

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

Also known as: Internet based intervention
Enhanced 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
ControlEnhanced Internet-based intervention

Access to a discussion forum for Cardiovascular Disease Rehabilitation.

Also known as: Internet based intervention
ControlEnhanced 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
Enhanced Internet-based intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Technological illiteracy
  • Inability to access internet at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skibotn Rehabilitering

Ivgobahta, Troms, 9143, Norway

Location

Related Publications (3)

  • 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.

    PMID: 22776554BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Silje Camilla Wangberg, PhD

    Kompetansesenter for Rus, Nord-Norge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2010

First Posted

October 18, 2010

Study Start

January 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations