Clinical trial NCT06547970: Pharmacist Led Educational Intervention on QOL, Medication Adherence & Satisfaction on Patients With Type 1 DM
Official title: The Impact of Pharmacist Led Education Program on Glycemic Control, Quality of Life and Medication Adherence Among Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycated hemoglobin A1c (%) (HbA1c)
timeFrame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
measure: The Quality of Life Scale (QoL)
timeFrame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Secondary outcomes:
measure: Anti-Diabetic Medication Adherence Scale (IADMAS)
timeFrame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
measure: Insulin self-administration assessment checking list
timeFrame: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Al-kindy Specialized center for endocrine diseases and diabetes
Study officials:
affiliation: Baghdad University
name: Ali Lateef Jasim, PhD
role: STUDY_DIRECTOR
References: