A Community Pharmacy-based Program to Improve Management of Diabetes
|ClinicalTrials.gov Identifier: NCT01525992|
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Community pharmacist-led diabetes education program Other: Usual care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2013|
|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 .
|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.
- Hemoglobin A1c [ Time Frame: 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) .
- Medication adherence [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from baseline (at the point of recruiting) Blood pressure at 6 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525992
|Iran, Islamic Republic of|
|Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences|
|Tehran, Iran, Islamic Republic of|
|Study Chair:||Kheirollah Gholami, M.Sc, PharmD||Tehran University of Medical Sciences|
|Study Director:||Zahra Jahangard-Rafsanjani, 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|