The Impact of Pharmacist Led Education Program on Glycemic Control, Quality of Life and Medication Adherence Among Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin A1c (%) (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Educational intervension (Other)
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
干预措施: Educational intervension (Other)
结局指标
主要结局
Glycated hemoglobin A1c (%) (HbA1c)
时间窗: Baseline (beginning of the intervention) and the end of 3 months follow-up.
Measurement of Glycated hemoglobin A1c (%) (HbA1c) at beginning of the intervention and the end of 3 months follow-up.
The Quality of Life Scale (QoL)
时间窗: Baseline (beginning of the intervention) and the end of 3 months follow-up.
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.
次要结局
- Insulin self-administration assessment checking list(Baseline (beginning of the intervention) and the end of 3 months follow-up.)
- Anti-Diabetic Medication Adherence Scale (IADMAS)(Baseline (beginning of the intervention) and the end of 3 months follow-up.)
研究者
Marwah Salman Abdulrahman
clinical pharmacist
University of Baghdad