Pharmacist-Led Educational Intervention for Diabetic Patients: a Randomized Interventional Trial to Evaluate the Impact on Medication Adherence and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Medication adherence score
研究概览
简要总结
This interventional study will to assess the impact of pharmacist-led educational intervention along with cognitive behavioral intervention in diabetic patients. Participants of this study will be provided regular counselling or cognitive behavioral intervention and educational material as part of their routine pharmacy visit. Researchers will compare the two groups to see which of the two groups improve in term of medication adherence and quality of life.
详细描述
The purpose of the study is to investigate whether incorporating pharmacist-led educational interventions along with Cognitive Behavioral Therapy (CBT) can result in better outcomes for diabetic patients. Effective diabetes management requires proper education and adherence to medication. Missed doses or irregular medication use can lead to poor glycemic control and increased complications. The study will examine if educational interventions along with Cognitive Behavioral Therapy (CBT) can have a favorable effect on various aspects of diabetes management coping techniques, Medication beliefs, reduction in hypo and hyperglycemic frequency, HbA1c and medication related problems (MRPs) medication adherence and overall quality of life of 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
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be entertained as part of their regular appointment for prescription filling without any information of which group they are assigned in. Moreover, following intervention, the outcomes will be assessed by the investigator who will be blinded about the participant group.
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All confirmed Type II diabetic patients who visit endocrinology OPD Clinic during study duration.
- •Patients having HbA1c >8%. Follow up as well as new patients were included subjects willing to participate in the study with or without other severe co-morbidities were included in the study.
排除标准
- •GDM diabetic patients Patients with Central Obesity Type I DM Patients Patients with inadequate medical history Patient having HbA1c <8% Patient who are not interested in the study are excluded.
研究组 & 干预措施
Control Group
Routine healthcare practices and protocols for diabetes management. Regular advice on medication, diet, and lifestyle modifications in accordance with established guidelines, Follows conventional approaches. Lifestyle Modification(Provide guidance on how to maintain a healthy lifestyle, including balanced diet, exercise and regular sleep patterns). General Knowledge advancement. General knowledge about disease and medicine. Pill planner will be provided to keep them adherent to their medication. General Medication counselling.
干预措施: Basic Education (Other)
Cognitive Behavioral Interventional Group
Specific Patient-centered strategies beyond routine care designed to address individualized needs. Customized interventions, including pharmacist-led educational sessions, personalized counseling, or advanced lifestyle modifications. Aims to enhance patient outcomes by providing tailored and innovative solutions for better diabetes management.
Change in lifestyle / link with any daily activity (Yoga and Meditation Specifically guide about food portions and how to balance each food group in daily routine along with recommended daily physical activity type and duration. Pill planner will also be provided to this group.
Medication counselling, Insulin technique, Dose Adjustment, Titration, Insulin Correction.
Cognitive Behavioral Therapy will be provided.
干预措施: Pharmacist-led Cognitive Behavioral therapy (Behavioral)
结局指标
主要结局
Medication adherence score
时间窗: 3 months
Adherence will be assessed using (Medication Adherence Reporting Scale) MARS-10. This scale describes three-dimension, Medication adherence behavior (1-4), attitude towards taking medication (5-8), negative side effects and attitudes to psychotropic medication (9-10). Each question has Yes and No response, a response consistent with adherence is coded as 1 and with non-adherence coded as 0. Higher the score higher will be the adherence. Adherence \<6 is poor adherence, and \>8 is high adherence.
Quality of life Score
时间窗: 3 months
Patient's quality of life will be assessed using Revised Version of DQOL (RV-DQOL13 ; Audit of diabetes dependent quality of life) will be used to access the quality of life of the patient. Its scoring ranges from 1- 100
次要结局
- Incidence of Drug-Drug Interactions(3 months)
- HbA1c %(3 months)
研究者
Matti Ullah
Assistant Professor
Hamdard University