NCT01525992

A Community Pharmacy-based Program to Improve Management of Diabetes

A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In this study the investigators aim to evaluate the impact of a community pharmacy-based program to educate type 2 diabetic patients about medications, life style and self-care.

Detailed description

Diabetes mellitus type 2 is a progressive metabolic disorder that leads to several morbidities and increased mortality and costs. Studies showed that strict control of blood glucose in diabetic patients reduces patients' risk of microvascular complications. Community pharmacies are a well-placed healthcare facility located at the heart of the community with convenient access to pharmacists as health care professionals. Some studies have shown effective interventions led by community and clinical pharmacist in developed countries. In developing countries, little evidence exists about feasibility of implementing community pharmacy-based services to promote medications adherence, self glucose monitoring and self-care in diabetic patients. This study is a 2 arm randomized controlled trial. Eligible patients are referred to the community pharmacy from an endocrinologist's office. Of 135 type-2 diabetic patients who will be recruited in the study,68 will be randomly allocated to the intervention arm using telephone balanced blocked randomization method. A community pharmacy-based program will provide training about medications, life style and self-care to the intervention arm. The control arm (67 patients) will receive usual care during the study period. The primary outcome of this study is measured as change in hemoglobin A1C pre and post intervention. As the secondary outcome, medications adherence, diabetes self-care activity, body mass index and blood pressure are measured.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
BEHAVIORAL	Community pharmacist-led diabetes education program	A trained pharmacist will counsel each patient based on his/her individual needs about medications, life style and self-care. The pharmacist will use a checklist to document the type of education delivered to each patient. A glucometer is provided for each patient in this arm to monitor blood glucose daily. Three to six visits to the community pharmacy are set during the 6-months study period. At each visit, medication related problems and self-care issues are discussed with the patient and the glucometer test strips are provided for the following month. A telephone call will be made to each patient between visits to ensure adherence to drug therapy and resolve any problems .
OTHER	Usual care	The baseline and 6-month follow-up visits to the community pharmacy will be required. If the physician prefers more visits to his office during the study period, it will be granted. The glucometer and a training session about diabetes self-care will be provide at the end of study for control group patients.

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-02-03
• Last updated: 2014-04-17

Locations

1 site across 1 country: Iran