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Completed

NCT Number: NCT00846300

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christus Memorial Hospital, Corpus Christi, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician counseling for health behavior change

Behavioral

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

Primary outcomes

  1. Change in self-reported medication knowledge

    Time frame: 6 and 12 weeks post-intervention

  2. Change in self-reported medication compliance

    Time frame: 6 and 12 weeks post intervention

  3. Change in HbA1c for patients with Diabetes

    Time frame: 1 year post intervention

  4. Change in Lipids

    Time frame: 1 year post intervention

  5. Change in blood pressure

    Time frame: 1 year post intervention

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Feb 18, 2009
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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