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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Glycated hemoglobin A1c (%) (HbA1c) [Срок оценки: Baseline (beginning of the intervention) and the end of 3 months follow-up.]
• The Quality of Life Scale (QoL) [Срок оценки: Baseline (beginning of the intervention) and the end of 3 months follow-up.]

Вторичные конечные точки (2)

• Anti-Diabetic Medication Adherence Scale (IADMAS) [Срок оценки: Baseline (beginning of the intervention) and the end of 3 months follow-up.]
• Insulin self-administration assessment checking list [Срок оценки: Baseline (beginning of the intervention) and the end of 3 months follow-up.]

Критерии участия

Критерии включения

• \- 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Ирак · 1 центр

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

Идентификаторы

NCT: NCT06547970 · DM type 1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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