Pharmacist Led Educational Intervention on QOL, Medication Adherence & Satisfaction on Patients With Type 1 DM

August 7, 2024 updated by: Marwah Salman Abdulrahman, University of Baghdad

The Impact of Pharmacist Led Education Program on Glycemic Control, Quality of Life and Medication Adherence Among Patients With Type 1 Diabetes Mellitus

There was no previous study in Iraq to evaluate the efficacy of pharmacist-led educational intervention on patient glycemic control, quality of life and medication adherence among type 1 diabetic patients in Iraq.

Improving diabetes patients' information's about their disease control, the role of insulin and the right technique to administer it, how to deal with hyper- and hypoglycemia, about their diet and exercise.

It is important to conduct a study to evaluate the pharmacist's role in education and improving patients' quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim of the Study:

The aim of the current study is to evaluate the impact of pharmacist-led educational intervention on glycemic control, quality of life and medication adherence among type 1 diabetic patients.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iraq
      • Baghdad, Iraq, 12221
        • Recruiting
        • Al-kindy Specialized center for endocrine diseases and diabetes
        • Contact:
          • Mukdad Al Hilal, PhD
          • Phone Number: 00964 7712763103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Patients age ≥ 16 years old who can speak and read the Arabic language.
  • Had been diagnosed with T1DM for at least 6 months ago.
  • Had uncontrolled hyperglycemia (glycosylated hemoglobin HbA1C ≥7% and/or fasting blood glucose >130 mg/dl)
  • Patients on the same regimen the last 3 months.
  • patients (or parents) acceptance to participate in the study.

Exclusion Criteria:

  • 1-Patient who have hearing, speech or cognitive deficits that would impair understanding of the questions and receiving the education.

    2- Patients with comorbid conditions that may interfere with the study such as asthma, thyroid disorders, adrenal gland disorders, celiac disease, or significant renal impairment.

    3-Patients who are taking corticosteroids. 4- Patients who required changing their insulin regimen, increasing the dose >20% of the previous dose. (21) 5- Patients with conditions that affect red blood cell turnover (hemolytic and other anemias, G-6-PD deficiency, recent blood transfusion, use of drugs that stimulate erythropoiesis, end stage kidney disease and pregnancy.

    6-Patients unwilling to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control (no education)
a group of DM patients we will record their HbA1C , FBG & their QOL by filling the questionnaire (will be filled by the researcher herself then after 3 months we are going to record the same variables
Other: Educational intervension
an educational intervention about the disease, symptoms & how to deal with these symptoms, foot care, life style like sport and nutritional advices
Other Names:
  • follow up
Active Comparator: Patient education
a group of DM patients we will record their HbA1C , FBG & their QOL, medication adherence , insulin taking technique form ( the questionnaire & form will be filled by the researcher herself) then an educational session will last about 30 min. will be given to each patient face to face at the last the recearcherr and the patients will share their phone numbers for following up then after 3 months all the variables will be recorded again
Other: Educational intervension
an educational intervention about the disease, symptoms & how to deal with these symptoms, foot care, life style like sport and nutritional advices
Other Names:
  • follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin A1c (%) (HbA1c)
Time Frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Measurement of Glycated hemoglobin A1c (%) (HbA1c) at beginning of the intervention and the end of 3 months follow-up.
Baseline (beginning of the intervention) and the end of 3 months follow-up.
The Quality of Life Scale (QoL)
Time Frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
The score consists of four major domains including general health, social, psychological, and satisfaction issues. Ten items were selected to formulate the quality-of-life scale for Iraqi DM patients (QOLSID). The first four questions with question ten are used to directly assess satisfaction, question five is used to assess social issue while questions six and seven were used to assess emotion and stress finally question eight and nine are directly used to assess health issue. The score of each question range from 0 (poor) to 5 (optimum). Items 1,2,6 and 7 with reverse scoring. Total score = direct summation of all items scores. Total scores ≥ 32.5 points refer to good quality of life.
Baseline (beginning of the intervention) and the end of 3 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Diabetic Medication Adherence Scale (IADMAS)
Time Frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
The scale consists of eight items; three items are used to directly assess medication-taking behavior by giving five responses: (1) always (daily), (2) often, (3) sometimes, (4) rarely and (5) never. The remaining five items are used to measure the determinant of non-adherence by giving a dichotomous response of "Yes" or "No". The first item aims to identify the extent of unintentional missing of medication doses; all other questions were directed to identify the extent of intentional medication non-adherence. Two items (1 and 3) were used to identify the extent of non-adherence to the time of medication taking. Four items (2, 6, 7 and 8) were formulated to identify the extent of intentional non-adherence with the prescribed medication dose. Only one item (5) aims to identify the extent of intentional non-adherence through discontinuation of taking DM medication. Scoring of all items ranged from 0 to 1, 0 for non-adherent answer and 1 for total adherence.
Baseline (beginning of the intervention) and the end of 3 months follow-up.
Insulin self-administration assessment checking list
Time Frame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
The assessment form was developed based on the latest expert recommendations for best practice in insulin injection technique. to assess pharmacists' counseling and educational role about the use of insulin. Areas of assessment include Preparations for injecting insulin contain six questions, Insulin injecting technique contain nine questions, Storage and stability of insulin contain 2 questions. the answers would be yes and no
Baseline (beginning of the intervention) and the end of 3 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Study Director: Ali Lateef Jasim, PhD, Baghdad University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM type 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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