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

NCT06547970 | Recruiting DMC

• 1 other identifier: DM type 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin A1c (%) (HbA1c)

  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)

  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 Outcomes (2)

• Anti-Diabetic Medication Adherence Scale (IADMAS)

  Baseline (beginning of the intervention) and the end of 3 months follow-up.

• Insulin self-administration assessment checking list

  Baseline (beginning of the intervention) and the end of 3 months follow-up.

Study Arms (2)

Control (no education)

PLACEBO COMPARATOR

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

Patient education

ACTIVE COMPARATOR

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

Interventions

Educational intervension OTHER

an educational intervention about the disease, symptoms \& how to deal with these symptoms, foot care, life style like sport and nutritional advices

Also known as: follow up

Control (no education); Patient education

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• Patient who have hearing, speech or cognitive deficits that would impair understanding of the questions and receiving the education.
• Patients with comorbid conditions that may interfere with the study such as asthma, thyroid disorders, adrenal gland disorders, celiac disease, or significant renal impairment.
• 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.
• Patients unwilling to participate.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Al-kindy Specialized center for endocrine diseases and diabetes

Baghdad, 12221, Iraq

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ali Lateef Jasim, PhD

  Baghdad University

  STUDY DIRECTOR

Central Study Contacts

Marwa Al Mukhtar, MSc

CONTACT

7901735013; marwa.abd2200m@copharm.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 12, 2024
• Study Start: February 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

IR (1)