Cardiovascular DiseaseNCT02438943
An Intervention to Improve Management of Dyslipidemia in Primary Care
A study testing Audit and Physician Intervention in people with Cardiovascular Disease and Dyslipidemia, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
To assess the effectiveness of a clinical audit and physician based intervention in improving the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Disease, Dyslipidemia, Diabetes Melletus
- What is being tested?
- Audit and Physician Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteJamaica
- Study dates
- Feb 2014to Dec 2016
- 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
- Attended the clinic for at least 18 months
- Is diagnosed with any of hypertension, diabetes, dyslipidemia, stroke, coronary heart disease (including angina, myocardial infarction), congestive cardiac failure or peripheral arterial disease, were eligible to be included in the audit
Who cannot join
- acutely ill or was diagnosed with established kidney disease
Trial locations and contacts
1 site in 1 country.
Michelle Harris contact
Jamaica1 site, 1 recruiting
- Recruiting
University of the West Indies, mona
Kingston
Michelle Harris, michelle.harris06@uwimona.edu.jm
About this study
Official title: A Cluster Randomized Controlled Trial of an Intervention to Improve the Management of Dyslipidemia in Primary Care
To assess the effectiveness of a clinical audit and physician based intervention in improving the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica
- Conditions
- Cardiovascular Disease, Dyslipidemia, Diabetes Melletus, Obesity
- Being tested
- Audit, Physician Intervention
- Medical subject headings
- Cardiovascular Diseases, Dyslipidemias, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuditOther
An assessment of medical records using a pre-specified audit instrument to assess the level of care given for clinic attendees with cardiovascular disease including dyslipidemia
Physician InterventionOther
Feedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session
| Study group | Role | What they receive |
|---|---|---|
| Audit and Physician intervention | Active comparator | The intervention will comprise the feedback of the results of the baseline audit, training in motivational interviewing for clinic staff, use of a physician reminder stamp in the patients' charts and distribution of patient education cards Receives: Other: Audit; Other: Physician Intervention |
| Audit only | Sham comparator | The intervention will comprise the feedback of the results of the baseline audit only Receives: Other: Audit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of persons attending health centers in the Southeast Health region with normal lipid values
Measured: 1 year
Secondary outcomes (2)
Proportion of persons attending health centers in the Southeast Health region with normal glucose values
Measured: 1 year
Proportion of persons attending health centers in the Southeast Health region with normal blood pressure values
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438943
- Sponsor's protocol ID
- ECP218,11/12
- Status last verified
- May 2015
- First submitted
- 5 May 2015
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial of an Intervention to Improve the Management of Dyslipidemia in Primary Care
- ClinicalTrials.gov ID
- NCT02438943
- Acronym / sponsor ID
- ECP218,11/12
- Conditions
- Cardiovascular Disease, Dyslipidemia, Diabetes Melletus, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 May 2015 (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.
To assess the effectiveness of a clinical audit and physician based intervention in improving the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audit and Physician intervention | Active comparator | Other: Audit, Other: Physician InterventionThe intervention will comprise the feedback of the results of the baseline audit, training in motivational interviewing for clinic staff, use of a physician reminder stamp in the patients' charts and distribution of patient education cards |
| Audit only | Sham comparator | Other: AuditThe intervention will comprise the feedback of the results of the baseline audit only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Attended the clinic for at least 18 months
- Is diagnosed with any of hypertension, diabetes, dyslipidemia, stroke, coronary heart disease (including angina, myocardial infarction), congestive cardiac failure or peripheral arterial disease, were eligible to be included in the audit
Key exclusion criteria (1 listed)
- acutely ill or was diagnosed with established kidney disease
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 |
|---|---|---|
| AuditAn assessment of medical records using a pre-specified audit instrument to assess the level of care given for clinic attendees with cardiovascular disease including dyslipidemia | Other | Audit and Physician intervention, Audit only |
| Physician InterventionFeedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session | Other | Audit and Physician intervention |
Primary outcome
Proportion of persons attending health centers in the Southeast Health region with normal lipid values
Time frame: 1 year
2 secondary outcomes
Proportion of persons attending health centers in the Southeast Health region with normal glucose values
Time frame: 1 year
Proportion of persons attending health centers in the Southeast Health region with normal blood pressure values
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
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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.
Michelle Harris contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Physician Intervention in people with Cardiovascular Disease and Dyslipidemia, run by The University of The West Indies at 1 site in Jamaica.
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 1 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 8 May 2015. 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 Jamaica. 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. Some participants in this study may receive a placebo. 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 Michelle Harris (michelle.harris06@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of persons attending health centers in the Southeast Health region with normal lipid values (time frame: 1 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 8 May 2015.