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

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00846300
First received: February 17, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Hyperlipidemia
Hypertension
Behavioral: Physician counseling for health behavior change

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Change in self-reported medication knowledge [ Time Frame: 6 and 12 weeks post-intervention ] [ Designated as safety issue: No ]
  • Change in self-reported medication compliance [ Time Frame: 6 and 12 weeks post intervention ] [ Designated as safety issue: No ]
  • Change in HbA1c for patients with Diabetes [ Time Frame: 1 year post intervention ] [ Designated as safety issue: No ]
  • Change in Lipids [ Time Frame: 1 year post intervention ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: 1 year post intervention ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: August 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Physician counseling for health behavior change
    Physician counseling for health behavior change, compared to a no-counseling comparison group
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846300

Locations
United States, Texas
Christus Memorial Hospital
Corpus Christi, Texas, United States, 78405
Valley Baptist Family Medicine Residency Program
Harlingen, Texas, United States, 78550
Laredo Medical Group
Laredo, Texas, United States
McAllen Family Medicine Residency Program
McAllen, Texas, United States, 78503
Dept Family & Community Medicine, UTHSCSA
San Antonio, Texas, United States, 78229
Family Medicine Residency Program, Christus Santa Rosa Hospital
San Antonio, Texas, United States, 78207
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Sandra Burge, Ph.D. University of Texas Health Science Center - San Antonio
  More Information

No publications provided

Responsible Party: Sandra Burge, Ph.D., UTHSCSA
ClinicalTrials.gov Identifier: NCT00846300     History of Changes
Other Study ID Numbers: HP000016-01
Study First Received: February 17, 2009
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Patient compliance
Hispanics
Health Behavior
Family Physicians
Primary Healthcare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperlipidemias
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014