A Community Pharmacy-based Program to Improve Management of Diabetes

NCT01525992 | Completed

• 1 other identifier: 90-04-156-16161
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Community Pharmacy Services; Pharmacists; Diabetes Mellitus; Diabetes Mellitus, Type 2; Self Care; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  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) .

  Change from baseline (at the point of recruiting) Hemoglobin A1c at 6 months.

Secondary Outcomes (4)

• 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.

Study Arms (2)

Community Pharmacy-based Program

EXPERIMENTAL

Behavioral: Community pharmacist-led diabetes education program

Usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Community pharmacist-led diabetes education program BEHAVIORAL

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 .

Community Pharmacy-based Program

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients requiring adjunct insulin therapy.
• Patients with concurrent heart failure (stage 4).
• Patients who fast in Ramadan.
• Patients receiving diabetes education in other programs.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Research Center for Rational Use of Drugs: collaborator

Study Sites (1)

Taleghani Community Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kheirollah Gholami, M.Sc, PharmD

  Tehran University of Medical Sciences

  STUDY CHAIR

• Zahra Jahangard-Rafsanjani, PharmD

  Tehran University of Medical Sciences

  STUDY DIRECTOR

• Arash Rashidian, MD, Ph.D

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Navid Saadat, MD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Amir Sarayani, PharmD, MPH

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 3, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

IR (1)