The Medication Adherence Program

Diabetes Clinical Trial

— MAP  

Official title:

The Medication Adherence Program:Promoting Diabetes Self-Management Through Community Pharmacies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00838344
• Other study ID #: 33084-D
• Secondary ID: 07-9030-D-01RFA0
• Status: Active, not recruiting
• Phase: N/A
• First received: February 5, 2009
• Last updated: September 28, 2009
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2009
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators will evaluate the impact of a Medication Adherence Program (MAP), a systematic telephone call to patients who are overdue for refills, to assess individual reasons or barriers to refilling prescribed DM medicines, discuss diabetes care progress, and provide intervention to resolve any barriers to taking prescribed medicines. The hypothesis for the study is that personalized telephone follow-up by a pharmacist will assist people who have missed refilling their prescriptions in taking diabetes medicines by resolving medication adherence challenges. Following randomization, the intervention will be offered to patients of four Seattle-area Safeway Pharmacies, Inc, who are overdue for prescribed DM medicine refills by at least 6 days. Control subjects will receive usual pharmacy care at the participating Safeway pharmacies as a comparison. The study will provide medication adherence support to intervention subjects for 12 months following enrollment with the goal of improving medication refilling and persistence.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Treatment

Intervention

Other:
• Medication Adherence Program (MAP)
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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	American Association of Diabetes Educators

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	medication adherence		12 months	No
Secondary	medication adherence challenges		12 months	Yes