Diabetes Mellitus, Type 2 Clinical Trial
Official title:
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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