HypercholesterolemiaPLEGATSNCT01308866
Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
A study testing Share decision tool in people with Hypercholesterolemia and Cardiovascular Risk, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites in Spain.
Trial summary
BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction… Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Hypercholesterolemia, Cardiovascular Risk
- What is being tested?
- Share decision tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 2 sitesSpain
- Study dates
- Jul 2007to Mar 2011
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers.
- Patients who allow to participate in this study
Who cannot join
- Patients with mental disorders.
- Secundary cardiovascular risk patients
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Capse-Gesclínic
Barcelona, Barcelona, 08036
Cap El Castell
Castelldefels, 08860
About this study
BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.
METHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007.
Read more
RESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care.
CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
- Conditions
- Hypercholesterolemia, Cardiovascular Risk
- Being tested
- Share decision tool
- Keywords
- cardiovascular diseases, patient education, primary health care, consumer participation, decision aids
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Share decision toolBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Intervention | Experimental | Intervention arm using a share-decision tool for cardiovascular patients Receives: Behavioral: Share decision tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk reduction
Cardiovascular risk reduction measured throught REGICOR Spanish scale
Measured: one year
Secondary outcomes (3)
Life self-perceived quality
Throught questionnaire SF-12
Measured: one year
Anxiety and depression
Throught HADS scale
Measured: one year
Decision empowerment
Otawa's decision scale
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJul 2007
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Investigators
- Joan Gene-Badia, MD, PhD, Principal investigator, University of Barcelona, CAPSE, Health Policy MonitorPatricia Fernandez-Vandellos, RN, MpH, Study chair, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308866
- Sponsor's protocol ID
- PLEGATS
- Acronym
- PLEGATS
- Status last verified
- Mar 2011
- First submitted
- 2 Mar 2011
- Last updated
- 4 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Shared Decision Aid Tool for Cardiovascular Risk Prevention in Hypercholesterolemic Patients
- ClinicalTrials.gov ID
- NCT01308866
- Acronym / sponsor ID
- PLEGATS / PLEGATS
- Conditions
- Hypercholesterolemia, Cardiovascular Risk
- Keywords
- cardiovascular diseases, patient education, primary health care, consumer participation, decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Jul 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Mar 2011 (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.
BACKGROUND: Mediterraneans have traditionally a low cardiovascular risk, although emerging lifestyles might change the trend. The aim of this study is to assess if hypercholesterolemic patient involvement in the preventive decision with the help of a decision aid has an impact on cardiovascular (CV) risk reduction superior to usual care.
METHOD: The design is a cluster randomised clinical trial. Participants are hypercholesterolemic patients (>200 mg/dl or c-LDL>130) from four primary care teams of Barcelona. Patients with previous CV events, age over 75 years or cognitive impairment are excluded. It is expected to create two cohorts of 139 patients each one. The randomisation is by doctor. Intervention group will receive information about their CV risk and the risk and benefits of different preventive measures. They will have access to a decission aid that will help them in the choice of the preventive measures.The material (printed and software) is adapted to the Catalan Population using local CV risk tables and will meet the CREDIBLE and DISCERN criteria. STUDY VARIABLES: Sociodemographic variables, CV risk factors, subjective health (SF 12), decisional conflict, anxiety/depression, analytic controls, treatment, treatment adherence, compliance and resources use. Basal evaluation and 3, 6, 12 month assessment. The study, financed by FIS, will begin the 01-07-2007.
RESULTS: The expected results are a higher reduction on the CV risk factors in the intervention group versus regular care.
CONCLUSIONS Study will provide a tool to be used in Spanish and Catalan population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Intervention | Experimental | Behavioral: Share decision toolIntervention arm using a share-decision tool for cardiovascular patients |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 14 and 75 years old having the inclusion criteria and consulting for cardiovascular risk diseases (CVD) in these centers.
- Patients who allow to participate in this study
Key exclusion criteria (2 listed)
- Patients with mental disorders.
- Secundary cardiovascular risk patients
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 |
|---|---|---|
| Share decision tool | Behavioural | Intervention |
Primary outcome
Cardiovascular risk reduction
Time frame: one year
Cardiovascular risk reduction measured throught REGICOR Spanish scale
3 secondary outcomes
Life self-perceived quality
Time frame: one year
Anxiety and depression
Time frame: one year
Decision empowerment
Time frame: one year
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 4 Mar 2011.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
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 Gene-Badia, MD, PhD principal investigator
University of Barcelona, CAPSE, Health Policy Monitor
Patricia Fernandez-Vandellos, RN, MpH study chair
University of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Share decision tool in people with Hypercholesterolemia and Cardiovascular Risk, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 2 sites 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 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 4 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Cardiovascular risk reduction (time frame: one year). 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 4 Mar 2011.