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Sponsored by: |
The University of Texas Health Science Center at San Antonio |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00846300 |
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 |
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Diabetes Mellitus, Type 2 Hyperlipidemia Hypertension |
Behavioral: Physician counseling for health behavior change |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Caregiver), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study. |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
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 | |
Christus Memorial Hospital | |
Corpus Christi, Texas, United States, 78405 | |
Laredo Medical Group | |
Laredo, Texas, United States | |
Valley Baptist Family Medicine Residency Program | |
Harlingen, Texas, United States, 78550 | |
McAllen Family Medicine Residency Program | |
McAllen, Texas, United States, 78503 |
Principal Investigator: | Sandra Burge, Ph.D. | University of Texas Health Science Center - San Antonio |
Responsible Party: | UTHSCSA ( Sandra Burge, Ph.D. ) |
Study ID Numbers: | HP000016-01 |
Study First Received: | February 17, 2009 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00846300 History of Changes |
Health Authority: | United States: Institutional Review Board |
Patient compliance Hispanics Health Behavior Family Physicians Primary Healthcare |
Metabolic Diseases Hyperlipidemias Diabetes Mellitus, Type 2 Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders Hypertension |
Metabolic Diseases Hyperlipidemias Diabetes Mellitus, Type 2 Vascular Diseases Diabetes Mellitus Endocrine System Diseases |
Cardiovascular Diseases Glucose Metabolism Disorders Dyslipidemias Lipid Metabolism Disorders Hypertension |