Clinical trial NCT01525992: A Community Pharmacy-based Program to Improve Management of Diabetes
Official title: A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Community Pharmacy Services
Pharmacists
Diabetes Mellitus
Diabetes Mellitus, Type 2
Self Care
Randomized Controlled Trial
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Research Center for Rational Use of Drugs
First posted: 2012-02-03
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.
Secondary outcomes:
measure: Medication adherence
timeFrame: Change from baseline (at the point of recruiting) medication adherence at 6 months.
measure: Self-care activity
timeFrame: Change from baseline (at the point of recruiting) Self-care activity at 6 months.
measure: Body Mass Index
timeFrame: Change from baseline (at the point of recruiting) Body Mass Index at 6 months.
measure: Blood pressure
timeFrame: Change from baseline (at the point of recruiting) Blood pressure at 6 months.
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Kheirollah Gholami, M.Sc, PharmD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Zahra Jahangard-Rafsanjani, PharmD
role: STUDY_DIRECTOR
affiliation: Tehran University of Medical Sciences
name: Arash Rashidian, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Navid Saadat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Amir Sarayani, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References: