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Clinical Trials/NCT00846300
NCT00846300
Completed
N/A

An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.

The University of Texas Health Science Center at San Antonio6 sites in 1 country150 target enrollmentAugust 2001

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
150
Locations
6
Primary Endpoint
Change in HbA1c for patients with Diabetes
Status
Completed
Last Updated
10 years ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
August 2001
End Date
May 2003
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in HbA1c for patients with Diabetes

Time Frame: 1 year post intervention

Change in self-reported medication compliance

Time Frame: 6 and 12 weeks post intervention

Change in blood pressure

Time Frame: 1 year post intervention

Change in Lipids

Time Frame: 1 year post intervention

Change in self-reported medication knowledge

Time Frame: 6 and 12 weeks post-intervention

Study Sites (6)

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