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

NCT ID: NCT06547970

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-09-01

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Educational intervension

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Educational intervension

Intervention Type: OTHER

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

Interventions

Educational intervension

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

Intervention Type: OTHER

Other Intervention Names

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Marwah Salman Abdulrahman

clinical pharmacist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Lateef Jasim, PhD

Role: STUDY_DIRECTOR

Baghdad University

Locations

Al-kindy Specialized center for endocrine diseases and diabetes

Baghdad, , Iraq

Site Status: RECRUITING

Countries

Iraq

Central Contacts

Marwa Al Mukhtar, MSc

Role: CONTACT

marwa.abd2200m@copharm.uobaghdad.edu.iq

7901735013 ext. 00964

Facility Contacts

Mukdad Al Hilal, PhD

Role: primary

7712763103 ext. 00964

Other Identifiers

DM type 1

Identifier Type: -

Identifier Source: org_study_id