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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Community pharmacist-led diabetes education program; Other: Usual 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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	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.
Experimental: Community Pharmacy-based Program	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	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) .	Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	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.	Change from baseline (at the point of recruiting) medication adherence at 6 months.
Self-care activity	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.	Change from baseline (at the point of recruiting) Self-care activity at 6 months.
Body Mass Index	Weight (measured in kilograms) divided by square of height (measured in Meters).	Change from baseline (at the point of recruiting) Body Mass Index at 6 months.
Blood pressure		Change from baseline (at the point of recruiting) Blood pressure at 6 months.

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Collaborators: Research Center for Rational Use of Drugs
• Investigators: Study Director: Zahra Jahangard-Rafsanjani, PharmD, Tehran University Of Medical Sciences; Study Chair: Kheirollah Gholami, M.Sc, PharmD, Tehran University Of Medical Sciences; Principal Investigator: Arash Rashidian, MD, Ph.D, Tehran University Of Medical Sciences; Principal Investigator: Navid Saadat, MD, Shahid Beheshti University of Medical Sciences; Principal Investigator: Amir Sarayani, PharmD, MPH, Tehran University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 2, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Randomized Controlled Trial; Diabetes Mellitus, Type 2; Self Care; Pharmacists; Community Pharmacy Services
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 90-04-156-16161