Pharmacist Led Educational Intervention on QOL, Medication Adherence & Satisfaction on Patients With Type 1 DM
NCT Number: NCT06547970
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 1
Interventions: OTHER: Educational intervension
Sponsor: University of Baghdad
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-02-01
Completion Date: 2024-09-01
Locations: Al-kindy Specialized center for endocrine diseases and diabetes, Baghdad, 12221, Iraq

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.

Primary Outcome Measures: Glycated hemoglobin A1c (%) (HbA1c), Measurement of Glycated hemoglobin A1c (%) (HbA1c) at beginning of the intervention and the end of 3 months follow-up., Baseline (beginning of the intervention) and the end of 3 months follow-up.|The Quality of Life Scale (QoL), The score consists of four major domains including general health, social, psychological, and satisfaction issues. Ten items were selected to formulate the quality-of-life scale for Iraqi DM patients (QOLSID). The first four questions with question ten are used to directly assess satisfaction, question five is used to assess social issue while questions six and seven were used to assess emotion and stress finally question eight and nine are directly used to assess health issue. The score of each question range from 0 (poor) to 5 (optimum). Items 1,2,6 and 7 with reverse scoring. Total score = direct summation of all items scores. Total scores ≥ 32.5 points refer to good quality of life., Baseline (beginning of the intervention) and the end of 3 months follow-up.
Secondary Outcome Measures: Anti-Diabetic Medication Adherence Scale (IADMAS), The scale consists of eight items; three items are used to directly assess medication-taking behavior by giving five responses: (1) always (daily), (2) often, (3) sometimes, (4) rarely and (5) never. The remaining five items are used to measure the determinant of non-adherence by giving a dichotomous response of "Yes" or "No". The first item aims to identify the extent of unintentional missing of medication doses; all other questions were directed to identify the extent of intentional medication non-adherence. Two items (1 and 3) were used to identify the extent of non-adherence to the time of medication taking. Four items (2, 6, 7 and 8) were formulated to identify the extent of intentional non-adherence with the prescribed medication dose. Only one item (5) aims to identify the extent of intentional non-adherence through discontinuation of taking DM medication. Scoring of all items ranged from 0 to 1, 0 for non-adherent answer and 1 for total adherence., Baseline (beginning of the intervention) and the end of 3 months follow-up.|Insulin self-administration assessment checking list, The assessment form was developed based on the latest expert recommendations for best practice in insulin injection technique. to assess pharmacists' counseling and educational role about the use of insulin. Areas of assessment include Preparations for injecting insulin contain six questions, Insulin injecting technique contain nine questions, Storage and stability of insulin contain 2 questions. the answers would be yes and no, Baseline (beginning of the intervention) and the end of 3 months follow-up.