A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
Primary Purpose
Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician counseling for health behavior change
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Patient compliance, Hispanics, Health Behavior, Family Physicians, Primary Healthcare
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
Sites / Locations
- Christus Memorial Hospital
- Valley Baptist Family Medicine Residency Program
- Laredo Medical Group
- McAllen Family Medicine Residency Program
- Family Medicine Residency Program, Christus Santa Rosa Hospital
- Dept Family & Community Medicine, UTHSCSA
Outcomes
Primary Outcome Measures
Change in self-reported medication knowledge
Change in self-reported medication compliance
Change in HbA1c for patients with Diabetes
Change in Lipids
Change in blood pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT00846300
First Posted
February 17, 2009
Last Updated
October 7, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00846300
Brief Title
A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
Official Title
An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
Keywords
Patient compliance, Hispanics, Health Behavior, Family Physicians, Primary Healthcare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Physician counseling for health behavior change
Intervention Description
Physician counseling for health behavior change, compared to a no-counseling comparison group
Primary Outcome Measure Information:
Title
Change in self-reported medication knowledge
Time Frame
6 and 12 weeks post-intervention
Title
Change in self-reported medication compliance
Time Frame
6 and 12 weeks post intervention
Title
Change in HbA1c for patients with Diabetes
Time Frame
1 year post intervention
Title
Change in Lipids
Time Frame
1 year post intervention
Title
Change in blood pressure
Time Frame
1 year post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Burge, Ph.D.
Organizational Affiliation
University of Texas Health Science Center - San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christus Memorial Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78405
Country
United States
Facility Name
Valley Baptist Family Medicine Residency Program
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Laredo Medical Group
City
Laredo
State/Province
Texas
Country
United States
Facility Name
McAllen Family Medicine Residency Program
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Family Medicine Residency Program, Christus Santa Rosa Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Dept Family & Community Medicine, UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
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