Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Corporacion Parc Tauli.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by:
Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01089842
First received: March 18, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Coronary Disease
Atherosclerosis
Behavioral: Health coaching
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial to Assess the Efficacy and Cost-efficacy of Health Coaching to Promote Physical Activity in Secondary Prevention of Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by Corporacion Parc Tauli:

Primary Outcome Measures:
  • Patients achieving recommended physical activity (>600 MET-minute/week) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)


Secondary Outcome Measures:
  • Cost-efficacy of coaching [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cost-efficacy will be measured using SF-12v2 quality of life questionnaire

  • Improvement on functional capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention


Estimated Enrollment: 262
Study Start Date: June 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health coaching Behavioral: Health coaching
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.
No Intervention: Control Other: Usual care
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.

Detailed Description:

Cardiovascular diseases are the main cause of death in developed countries. Epidemiological studies have shown that a sedentary lifestyle is associated with an increased risk of cardiovascular diseases, mainly related to classical risk factors (obesity, diabetes, hypertension). International guidelines recommend, because of that, a minimum of 30 minutes per day at least 5 days per week of moderate physical activity for primary and secondary cardiovascular disease prevention.

Physical inactivity is an increasing public health problem in developed countries. It is known that clinical advice has a poor efficacy to increase levels of physical activity on individuals and new strategies need to be developed.

Coaching is a strategy of personal help that is being widely and successfully used in business world. It consists of an structured and individualized process of assistance to people to promote cognitive changes needed to achieve behavioural changes. It can be a complementary method to information and sanitary education emphasizing on consciousness and responsibility of the patient and is now starting to be used in medical practice. The purpose of the study is to define usefulness of an strategy based on coaching techniques to promote physical activity practice and healthy lifestyle on individuals with known coronary heart disease or cardiovascular risk factors.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).

Exclusion Criteria:

  • 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
  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: NCT01089842

Contacts
Contact: Joan R Guma 0034937231010 jgumag@gmail.com

Locations
Spain
Hospital de Sabadell Recruiting
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Instituto de Salud Carlos III
Investigators
Principal Investigator: Joan R Guma Corporacion Parc Tauli
  More Information

Additional Information:
No publications provided

Responsible Party: Joan R Guma, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01089842     History of Changes
Other Study ID Numbers: PI08/90182, CIR08/034
Study First Received: March 18, 2010
Last Updated: March 18, 2010
Health Authority: Spain: Ministry of Health and Consumption

Keywords provided by Corporacion Parc Tauli:
Secondary Prevention
Health Promotion
Behavioral Medicine
Exercise Therapy

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014