A Community Pharmacy-based Program to Improve Management of Diabetes

T

Tehran University of Medical Sciences

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Usual care
Behavioral: Community pharmacist-led diabetes education program

Study type

Interventional

Funder types

Other

Identifiers

NCT01525992
90-04-156-16161

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

Community Pharmacy-based Program
Experimental group
Treatment:
Behavioral: Community pharmacist-led diabetes education program
Usual care
Active Comparator group
Treatment:
Other: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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