- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846300
A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Corpus Christi, Texas, United States, 78405
- Christus Memorial Hospital
-
Harlingen, Texas, United States, 78550
- Valley Baptist Family Medicine Residency Program
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Laredo, Texas, United States
- Laredo Medical Group
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McAllen, Texas, United States, 78503
- McAllen Family Medicine Residency Program
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San Antonio, Texas, United States, 78207
- Family Medicine Residency Program, Christus Santa Rosa Hospital
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San Antonio, Texas, United States, 78229
- Dept Family & Community Medicine, UTHSCSA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in self-reported medication knowledge
Time Frame: 6 and 12 weeks post-intervention
|
6 and 12 weeks post-intervention
|
Change in self-reported medication compliance
Time Frame: 6 and 12 weeks post intervention
|
6 and 12 weeks post intervention
|
Change in HbA1c for patients with Diabetes
Time Frame: 1 year post intervention
|
1 year post intervention
|
Change in Lipids
Time Frame: 1 year post intervention
|
1 year post intervention
|
Change in blood pressure
Time Frame: 1 year post intervention
|
1 year post intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sandra Burge, Ph.D., University of Texas Health Science Center - San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP000016-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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