Diabetes Mellitus, Type 2NCT00846300
A Brief Intervention to Improve Medication Knowledge and Adherence Among Family Medicine Patients in South Texas
A study testing Physician counseling for health behavior change in people with Diabetes Mellitus, Type 2 and Hyperlipidemia, run by The University of Texas Health Science Center at San Antonio at 6 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
- What is being tested?
- Physician counseling for health behavior change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2001to May 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects under age 18
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Christus Memorial Hospital
Corpus Christi, Texas, 78405
Valley Baptist Family Medicine Residency Program
Harlingen, Texas, 78550
Laredo Medical Group
Laredo, Texas
McAllen Family Medicine Residency Program
McAllen, Texas, 78503
Family Medicine Residency Program, Christus Santa Rosa Hospital
San Antonio, Texas, 78207
Dept Family & Community Medicine, UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
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.
- Conditions
- Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
- Being tested
- Physician counseling for health behavior change
- Keywords
- Patient compliance, Hispanics, Health Behavior, Family Physicians, Primary Healthcare
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperlipidemias, Hypertension, Patient Compliance, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician counseling for health behavior changeBehavioural
Physician counseling for health behavior change, compared to a no-counseling comparison group
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported medication knowledge
Measured: 6 and 12 weeks post-intervention
Change in self-reported medication compliance
Measured: 6 and 12 weeks post intervention
Change in HbA1c for patients with Diabetes
Measured: 1 year post intervention
Change in Lipids
Measured: 1 year post intervention
Change in blood pressure
Measured: 1 year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Investigators
- Sandra Burge, Ph.D., Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846300
- Sponsor's protocol ID
- HP000016-01
- Status last verified
- Oct 2015
- First submitted
- 17 Feb 2009
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Improve Medication Knowledge & Compliance Among Family Practice Patients in South Texas: An RRNEST Study.
- ClinicalTrials.gov ID
- NCT00846300
- Acronym / sponsor ID
- HP000016-01
- Conditions
- Diabetes Mellitus, Type 2, Hyperlipidemia, Hypertension
- Keywords
- Patient compliance, Hispanics, Health Behavior, Family Physicians, Primary Healthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician counseling for health behavior changePhysician counseling for health behavior change, compared to a no-counseling comparison group | Behavioural | – |
Primary outcome
Change in self-reported medication knowledge
Time frame: 6 and 12 weeks post-intervention
Change in self-reported medication compliance
Time frame: 6 and 12 weeks post intervention
Change in HbA1c for patients with Diabetes
Time frame: 1 year post intervention
Change in Lipids
Time frame: 1 year post intervention
Change in blood pressure
Time frame: 1 year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Burge, Ph.D. principal investigator
The University of Texas Health Science Center at San Antonio
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician counseling for health behavior change in people with Diabetes Mellitus, Type 2 and Hyperlipidemia, run by The University of Texas Health Science Center at San Antonio at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported medication knowledge (time frame: 6 and 12 weeks post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015; AzTrials last refreshed its copy on 30 Oct 2026.