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CompletedNCT00846300Updated Oct 8, 2015

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

An interventional study of Physician counseling for health behavior change in Diabetes Mellitus, Type 2, Hyperlipidemia and Hypertension, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 6 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-10-08.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • Hyperlipidemia
  • Hypertension

Keywords

  • Patient compliance
  • Hispanics
  • Health Behavior
  • Family Physicians
  • Primary Healthcare
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 150 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects under age 18
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
Single (Care provider)
Enrollment
150 participants (actual)

Interventions

  • BehavioralPhysician counseling for health behavior change

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

06

What researchers measure

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

07

Study locations

6 sites
  • Christus Memorial Hospital
    Corpus Christi, Texas 78405, United States
  • Valley Baptist Family Medicine Residency Program
    Harlingen, Texas 78550, United States
  • Laredo Medical Group
    Laredo, Texas, United States
  • McAllen Family Medicine Residency Program
    McAllen, Texas 78503, United States
  • Family Medicine Residency Program, Christus Santa Rosa Hospital
    San Antonio, Texas 78207, United States
  • Dept Family & Community Medicine, UTHSCSA
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00846300
Lead sponsor
The University of Texas Health Science Center at San Antonio
First posted
Feb 18, 2009
Start date
Aug 2001
Primary completion
May 2003
Completion
May 2003
Last update
Oct 8, 2015

Study contacts

Sandra Burge, Ph.D.
principal investigator · University of Texas Health Science Center San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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