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An Intervention to Improve Management of Dyslipidemia in Primary Care

Primary Purpose

Cardiovascular Disease, Dyslipidemia, Diabetes Melletus

Status
Unknown status
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Audit
Physician Intervention
Sponsored by
The University of The West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • acutely ill or was diagnosed with established kidney disease

Sites / Locations

  • University of the West Indies, monaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Audit and Physician intervention

Audit only

Arm Description

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

The intervention will comprise the feedback of the results of the baseline audit only

Outcomes

Primary Outcome Measures

Proportion of persons attending health centers in the Southeast Health region with normal lipid values

Secondary Outcome Measures

Proportion of persons attending health centers in the Southeast Health region with normal glucose values
Proportion of persons attending health centers in the Southeast Health region with normal blood pressure values

Full Information

First Posted
May 5, 2015
Last Updated
May 5, 2015
Sponsor
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT02438943
Brief Title
An Intervention to Improve Management of Dyslipidemia in Primary Care
Official Title
A Cluster Randomized Controlled Trial of an Intervention to Improve the Management of Dyslipidemia in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of The West Indies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Dyslipidemia, Diabetes Melletus, Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Audit and Physician intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Audit only
Arm Type
Sham Comparator
Arm Description
The intervention will comprise the feedback of the results of the baseline audit only
Intervention Type
Other
Intervention Name(s)
Audit
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physician Intervention
Intervention Description
Feedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session
Primary Outcome Measure Information:
Title
Proportion of persons attending health centers in the Southeast Health region with normal lipid values
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of persons attending health centers in the Southeast Health region with normal glucose values
Time Frame
1 year
Title
Proportion of persons attending health centers in the Southeast Health region with normal blood pressure values
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: acutely ill or was diagnosed with established kidney disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Harris
Email
michelle.harris06@uwimona.edu.jm
First Name & Middle Initial & Last Name or Official Title & Degree
Marvin E Reid
Phone
8763812939
Email
marvin.reid@uwimona.edu.jm
Facility Information:
Facility Name
University of the West Indies, mona
City
Kingston
Country
Jamaica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Harris
Email
michelle.harris06@uwimona.edu.jm

12. IPD Sharing Statement

Learn more about this trial

An Intervention to Improve Management of Dyslipidemia in Primary Care

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