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

U

University of Baghdad

Status

Enrolling

Conditions

Diabetes Mellitus, Type 1

Treatments

Other: Educational intervension

Study type

Interventional

Funder types

Other

Identifiers

NCT06547970
DM type 1

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

Control (no education)
Placebo Comparator group
Description:
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
Treatment:
Other: Educational intervension
Patient education
Active Comparator group
Description:
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
Treatment:
Other: Educational intervension

Trial contacts and locations

1

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Central trial contact

Marwa Al Mukhtar, MSc

Data sourced from clinicaltrials.gov

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