Integrated Pharmaceutical Care Programme in Patients with Diabetes Mellitus An Interventional Cross Sectional Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 282
- 试验地点
- 2
- 主要终点
- Reduction in HbA1C levels in intervention group
研究概览
简要总结
Primary Purpose of study
In India very few studies done on proposed research problem. Since 1990 to 2022, 15 research were found in PubMed, Scopus, Web of science and Ovid Medline from India.
In India these epidemiological studies were carried out from south India Mumbai and North India. There is only two supportive research found from Gujarat state but it was only focused on KAP not a pharmaceutical care program.
In this field, this will be structured interventional pharmaceutical care research carried out in Gujarat, rather than unstructured conventional method. This study adds the variability of data from Gujarat state of India.
Previous research was mostly focused on out impact of education on patients KAP and QOL parameters and not every research was focused on HbA1c parameter. This research will be found out impact of education on patients HbA1c level.
Addition to KAP and QOL this study will find out diabetes distress levels, Adherence levels, cost of illness, Drug related problems and satisfaction level of patients towards pharmaceutical care from Gujarat, India.
Proposed Hypothesis of Study
Summary
This proposed research work is based on formulation and intervention of working model of Diabetes mellitus educational pharmaceutical care.
Outcome of this research will be improving knowledge and understanding of disease and enhancing self-management of disease among the patients.
By application of timely education and follow up, adherence of treatment and self-regulatory behavior will be enhanced and this will optimize the use of medicines.
Mostly the primary outcome of this research that will be reduction in HbA1C levels in intervention group.
Ultimate outcome of proposed study will be enhancing patients’ quality of life in the form of reduction of symptoms, improving self-management of disease and achieving goal of health promotion and prevention of progression of diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Type-II diabetes mellitus.
- •Patients with HbA1c more than 7%.
- •Patients who receiving oral hypoglycemic and/or insulin therapy.
- •Patients who provide written informed consent.
- •Patients who express willingness to participate in the study.
排除标准
- •Patients who are younger than 18 years (They are legally regarded as dependents and consequently they cannot take decisions of their own).
- •Pregnant Women.
- •Patients who will not willing to give consent to participate.
结局指标
主要结局
Reduction in HbA1C levels in intervention group
时间窗: Reduction in HbA1C levels exactly after 4 Times in each 4 month intervention during 16 month study period
次要结局
- enhancing patients quality of life in the form of reduction of symptoms(improving self-management of disease & achieving goal of health promotion & prevention of progression of diabetes mellitus)
研究者
Rishita Patel
INDUKAKA IPCOWALA COLLEGE OF PHARMACY