A Community Pharmacy-based Intervention on Type 2 Diabetic Patients to Improve Medications Adherence and Disease Outcomes; a Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Tehran University of Medical Sciences
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Hemoglobin A1c
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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) .
Secondary Outcomes
- Medication adherence(Change from baseline (at the point of recruiting) medication adherence at 6 months.)
- Self-care activity(Change from baseline (at the point of recruiting) Self-care activity at 6 months.)
- Body Mass Index(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.)