Coronary DiseaseNCT01089842
Health Coaching to Promote Physical Activity for Coronary Heart Disease Prevention
A study testing Health coaching in people with Coronary Disease and Atherosclerosis, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease, Atherosclerosis
- What is being tested?
- Health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2009to Jan 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Sabadell
Sabadell, Barcelona, 08208
About this study
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
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.
Read the 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.
- Conditions
- Coronary Disease, Atherosclerosis
- Being tested
- Health coaching, Usual care
- Keywords
- Secondary Prevention, Health Promotion, Behavioral Medicine, Exercise Therapy
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health coachingBehavioural
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.
Usual careOther
Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Health coaching | Experimental | Not described Receives: Behavioral: Health coaching |
| Control | No intervention | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients achieving recommended physical activity (>600 MET-minute/week)
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)
Measured: 6 months
Secondary outcomes (2)
Cost-efficacy of coaching
Cost-efficacy will be measured using SF-12v2 quality of life questionnaire
Measured: 6 months
Improvement on functional capacity
Exercise treadmill Bruce test will be used to assess cardiovascular fitness and compare functional capacity before and after intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Investigators
- Joan R Guma, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089842
- Sponsor's protocol ID
- PI08/90182
- Other IDs
- CIR08/034
- Status last verified
- Feb 2010
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01089842
- Acronym / sponsor ID
- PI08/90182
- Conditions
- Coronary Disease, Atherosclerosis
- Keywords
- Secondary Prevention, Health Promotion, Behavioral Medicine, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 19 Mar 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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health coaching | Experimental | Behavioral: Health coaching |
| Control | No intervention | Other: Usual care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients wiht coronary risk factors or known ischaemic heart disease defined as sedentary (<600MET-min/week).
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Health coachingCoaching 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. | Behavioural | Health coaching |
| Usual carePatients on control group will receive usual assistance, including physical activity counselling by their treating physician. | Other | Control |
Primary outcome
Patients achieving recommended physical activity (>600 MET-minute/week)
Time frame: 6 months
Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ)
2 secondary outcomes
Cost-efficacy of coaching
Time frame: 6 months
Improvement on functional capacity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2010.
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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.
Joan R Guma principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health coaching in people with Coronary Disease and Atherosclerosis, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2010. 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 Spain. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan R Guma (0034937231010, jgumag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients achieving recommended physical activity (>600 MET-minute/week) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2010.