- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00838344
The Medication Adherence Program (MAP)
The Medication Adherence Program:Promoting Diabetes Self-Management Through Community Pharmacies
Study Overview
Status
Intervention / Treatment
Detailed Description
Taking medicines can be a challenge for those with diabetes mellitus (DM) with adherence rates to DM medicines as low as 31%. Adherence to DM medicines improves DM by reducing blood glucose (ie A1c reduction) but will also result in improved outcomes, reduced cardiovascular risks, and reduced costs of diabetes. The most common factors reported to affect medication taking in those with DM include difficulty remembering refills and doses, regimen complexity (e.g more than one DM drug, need to split tablets, mix products), dosing frequency greater than twice daily, depression, and adverse effects or fear of them.
Pharmacists have immense opportunity to interact with people with DM, who now number over 20 million in the United States (US). This reality is due to several factors including convenience of pharmacies (found in most urban, suburban, and rural communities), accessibility of pharmacists for questions and counseling (appointments not usually required), and strong rapport that pharmacists and their staff develop with long-term patients and their families through their presence in the community. Pharmacists in community practices work directly with patients and review refill information about patient medication use thus allowing for personalized, immediate, and ongoing promotion of adherence. Currently, pharmacists do not routinely call patients who are overdue for prescription refills to ascertain if the refill is still needed or proactively work to resolve any barriers to refilling. The standard of care is to provide refill and medication adherence support if it is requested by a patient and if the pharmacy is able to provide the needed level of support.
In this study, we will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call by a pharmacist to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines and provide intervention to resolve any barriers.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 or older with type 2 diabetes on at least one oral diabetes medication who have missed a refill by 6 or more days
Exclusion Criteria:
- Those unable to converse in the same language as their usual care Safeway pharmacist (Spanish or English most common languages spoken at the site stores) or who do not have an interpreter, family member, friend, or caregiver who can act on the subject's behalf as an interpreter during the initial or any follow-up phone calls
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Usual care
Usual prescription refill system and pharmacy care.
|
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EXPERIMENTAL: Intervention
Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days.
Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.
|
Telephone follow-up call to individuals with diabetes (Type 2) who have missed a prescription refill by 6 or more days.
Call includes assessment of refill need, discussion of diabetes care progress and any medication adherence barriers with intervention to resolve barriers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
medication adherence
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
medication adherence challenges
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33084-D
- 07-9030-D-01
- RFA0100-06
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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