Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention
Randomized Clinical Trial to Assess the Efficacy and Cost-efficacy of Health Coaching to Promote Physical Activity in Secondary Prevention of Coronary Heart Disease
2 other identifiers
interventional
262
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy of motivational interviewing-based coaching to increase physical activity to achieve guidelines recommendations for cardiovascular disease prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMarch 19, 2010
February 1, 2010
2 years
March 18, 2010
March 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patients achieving recommended physical activity (>600 MET-minute/week)
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)
6 months
Secondary Outcomes (2)
Cost-efficacy of coaching
6 months
Improvement on functional capacity
6 months
Study Arms (2)
Health coaching
EXPERIMENTALControl
NO INTERVENTIONInterventions
Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.
Eligibility Criteria
You may qualify if:
- Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (\<600MET-min/week).
You may not qualify if:
- Bundle branch block or pacemaker rhythm
- Limitation or contraindication to moderate physical activity (fast walking)
- Unstable clinical situation
- Communication difficulties due to language or sensorial deficiencies.
- Lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corporacion Parc Taulilead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (1)
Hospital de Sabadell
Sabadell, Barcelona, 08208, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan R Guma
Corporacion Parc Tauli
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 19, 2010
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
January 1, 2012
Last Updated
March 19, 2010
Record last verified: 2010-02