A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas

NCT ID: NCT00846300

Last Updated: 2015-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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This study examined a brief intervention to improve medication knowledge and compliance in family medicine patients. The study was conducted in a network of six family medicine residency programs in South Texas, funded by a grant from the Health Research Services Administration. Family medicine patients were invited to participate in the study if they took medicines for type 2 diabetes, hypertension, or hyperlipidemia and responded "yes" to the screening question: "Do you sometimes have trouble taking all your medications as prescribed?"

At enrollment, clinic staff administered a Medication Survey to patients to assess the variables: readiness to change, reported medication knowledge; reported compliance, and predictors of knowledge and compliance. Self-reports of compliance were validated with a social desirability scale, and with physician impressions. Six and twelve weeks post-enrollment, interviewers administered followup surveys by telephone to assess change over time in medication knowledge and compliance. One year post-enrollment, investigators conducted a chart review to examine changes in health outcomes: blood pressure or HbA1c or cholesterol levels, and number of hospitalizations.

Three physicians per clinic site (18 total) conducted medication interventions for the purpose of this study. This intervention was brief behavior change counseling done in the context of a routine office visit, guided by simple strategies outlined in Rollnick et al (1999). First, physicians reviewed subjects= medication regimen and addressed their concerns. We selected a simple strategy from Rollnick et al. - a brainstorming session - that built patients' confidence to change health behaviors. Afterward, physicians offered pillboxes to patients who desired them, and reviewed potential adverse reactions to medicines. One week after the intervention, physicians telephoned patients to reinforce behavior change and to answer questions about the medications. Prior to training physicians to conduct this intervention, we enrolled five subjects per physician into a control group. We attempted to blind physicians to these patients= enrollment status; usual care was provided to control subjects. After training, enrollees' charts were flagged so that physicians knew to conduct the intervention. We sought five patients per physician to receive the intervention.

Conditions

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Diabetes Mellitus, Type 2 Hyperlipidemia Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Interventions

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Physician counseling for health behavior change

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Subjects under age 18
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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UTHSCSA

Principal Investigators

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Sandra Burge, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Locations

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Christus Memorial Hospital

Corpus Christi, Texas, United States

Site Status

Valley Baptist Family Medicine Residency Program

Harlingen, Texas, United States

Site Status

Laredo Medical Group

Laredo, Texas, United States

Site Status

McAllen Family Medicine Residency Program

McAllen, Texas, United States

Site Status

Family Medicine Residency Program, Christus Santa Rosa Hospital

San Antonio, Texas, United States

Site Status

Dept Family & Community Medicine, UTHSCSA

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HP000016-01

Identifier Type: -

Identifier Source: org_study_id

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