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A Community Pharmacy-based Program to Improve Management of Diabetes

This study is currently recruiting participants.
Verified April 2012 by Tehran University of Medical Sciences
Sponsor:
Collaborator:
Research Center for Rational Use of Drugs
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01525992
First received: January 31, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
 Behavioral: Community pharmacist-led diabetes education program
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months. ] [ Designated as safety issue: No ]
    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:
  • Medication adherence [ Time Frame: Change from baseline (at the point of recruiting) medication adherence at 6 months. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 135
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients using oral anti diabetic medications.
  • Hemoglobin A1c > 7.5%
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525992

Contacts
Contact: Zahra Jahangard-Rafsanjani, PharmD 00982188814157 zjahangard@razi.tums.ac.ir
Contact: Amir Sarayani, PharmD, MPH a-sarayanib@razi.tums.ac.ir

Locations
Iran, Islamic Republic of
Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Research Center for Rational Use of Drugs
Investigators
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 Shaheed Beheshti Medical University
Principal Investigator: Amir Sarayani, PharmD, MPH Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01525992     History of Changes
Other Study ID Numbers: 90-04-156-16161
Study First Received: January 31, 2012
Last Updated: April 5, 2012
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Community Pharmacy Services
Pharmacists
Diabetes Mellitus
 Diabetes Mellitus, Type 2
Self Care
Randomized Controlled Trial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013