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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00754741 |
The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.
Condition | Intervention | Phase |
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Diabetes |
Behavioral: Adherence information Behavioral: Adherence information plus motivational interviewing |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Phase III Clinical Trial of the Effectiveness of Adherence Data and Motivational Interviewing to Improve Medication Adherence and Both Glycated Hemoglobin and Cholesterol Control |
Estimated Enrollment: | 1584 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Usual care: No Intervention
All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
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Adherence: Active Comparator |
Behavioral: Adherence information
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
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Adherence Plus: Active Comparator |
Behavioral: Adherence information plus motivational interviewing
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
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Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes.
Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 3-arm randomized clinical trial to test the effectiveness of providing primary care physicians with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications.
Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system plus physicians and patients will receive support from an adherence clinic.
Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients' adherence and goal levels. The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Manel Pladevall, MD, MS | 313-874-4993 | mpladev1@hfhs.org |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 |
Study Director: | Janis Campbell, RN | Henry Ford Health System |
Responsible Party: | Henry Ford Hospital ( Manel Pladevall-Vila, MD, MS - Principal investigator ) |
Study ID Numbers: | DK64695, 5R01DK064695-06 |
Study First Received: | September 16, 2008 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00754741 |
Health Authority: | United States: Federal Government |
medication adherence, motivational interviewing |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |