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Recruiting NCT06547970

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

No phase Interventional Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational intervension.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Glycated hemoglobin A1c (%) (HbA1c) [Time frame: 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.]
Secondary outcome measures (2)
  • Anti-Diabetic Medication Adherence Scale (IADMAS) [Time frame: 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Iraq · 1 center
  • Al-kindy Specialized center for endocrine diseases and diabetes — Baghdad

Identifiers

NCT: NCT06547970 · DM type 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗