NCT02438943

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.8 years

First QC Date

May 5, 2015

Last Update Submit

May 5, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (2)

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

    1 year

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

    1 year

Study Arms (2)

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

Other: AuditOther: Physician Intervention

Audit only

SHAM COMPARATOR

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

Other: Audit

Interventions

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

Audit and Physician interventionAudit only

Feedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session

Audit and Physician intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • acutely ill or was diagnosed with established kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the West Indies, mona

Kingston, Jamaica

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesDyslipidemiasObesity

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations