NCT00846300

Brief Summary

This study examines a brief physician counseling intervention to improved medication knowledge and compliance in family medicine patients who have diabetes, hypertension or high cholesterol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

6 active sites

Status
completed

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

August 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

February 17, 2009

Last Update Submit

October 7, 2015

Conditions

Diabetes Mellitus, Type 2HyperlipidemiaHypertension

Keywords

Patient complianceHispanicsHealth BehaviorFamily PhysiciansPrimary Healthcare

Outcome Measures

Primary Outcomes (5)

  • Change in self-reported medication knowledge

    6 and 12 weeks post-intervention

  • Change in self-reported medication compliance

    6 and 12 weeks post intervention

  • Change in HbA1c for patients with Diabetes

    1 year post intervention

  • Change in Lipids

    1 year post intervention

  • Change in blood pressure

    1 year post intervention

Interventions

Physician counseling for health behavior changeBEHAVIORAL

Physician counseling for health behavior change, compared to a no-counseling comparison group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sometimes has trouble taking medicines as they're prescribed
  • Has diabetes type 2, or hypertension, or high cholesterol for which they take prescription medicines
  • Is a patient of 18 doctors conducting the intervention

You may not qualify if:

  • Subjects under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Christus Memorial Hospital

Corpus Christi, Texas, 78405, United States

Location

Valley Baptist Family Medicine Residency Program

Harlingen, Texas, 78550, United States

Location

Laredo Medical Group

Laredo, Texas, United States

Location

McAllen Family Medicine Residency Program

McAllen, Texas, 78503, United States

Location

Family Medicine Residency Program, Christus Santa Rosa Hospital

San Antonio, Texas, 78207, United States

Location

Dept Family & Community Medicine, UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HyperlipidemiasHypertensionPatient ComplianceHealth Behavior

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism DisordersVascular DiseasesCardiovascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Study Officials

  • Sandra Burge, Ph.D.

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

August 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

US(6)