A Community Pharmacy-based Program to Improve Management of Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Community pharmacist-led diabetes education program; Other: Usual care

• Registration Number: NCT01525992
• Lead Sponsor: Tehran University of Medical Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-03
• Study Start: 2012-03
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-16
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Type 2 diabetic patients using oral anti diabetic medications.
• Hemoglobin A1c > 7 within the previous month before recruitment
• Adequate literacy and ability to use the glucometer.
• Signing the informed consent

Exclusion Criteria

• Patients requiring adjunct insulin therapy.
• Patients with concurrent heart failure (stage 4).
• Patients who fast in Ramadan.
• Patients receiving diabetes education in other programs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Pharmacy-based Program	Community pharmacist-led diabetes education program	-
Usual care	Usual care	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.	Hemoglobin A1c is measured in all patients prior to participating in the study. All patients will be required to take the test again at the end of the study (6 months) .

Secondary Outcome Measures

Name	Time	Method
Medication adherence	Change from baseline (at the point of recruiting) medication adherence at 6 months.	Medication adherence will be measured using "Morisky Medication Adherence Questionnaire" which will be translated into Farsi.The validity and reliability of the translated questionnaire will be investigated primarily.
Self-care activity	Change from baseline (at the point of recruiting) Self-care activity at 6 months.	Self-care activity will be measured using "Diabetes Self-care Activity Measure" questionnaire which will be translated into Farsi. We will investigate the validity and reliability of the translated questionnaire.
Body Mass Index	Change from baseline (at the point of recruiting) Body Mass Index at 6 months.	Weight (measured in kilograms) divided by square of height (measured in Meters).
Blood pressure	Change from baseline (at the point of recruiting) Blood pressure at 6 months.

Trial Locations

Locations (1)

Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of