跳至主要内容
临床试验/CTRI/2019/02/017589
CTRI/2019/02/017589招募中不适用

A Randomized Controlled Trial to assess the Effectiveness of Group-Based Diabetes Self-Management Education(DSME) program on Glycemic Control, Self-Care Efficacy and Quality of life in individuals with Type-2 Diabetes.

Hamdard Institute of Medical Sciences and Research2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年1月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Glycemic Control and

研究概览

简要总结

Diabetes has increasingly become a major healthproblem worldwide. India hasn’t been far behind, having the secondhighest prevalence of diabetes, in advancing to 72·0 million prevalentcases of diabetes in 2017, as compared with 26·0 million in 1990. Thedevelopment of complications affects the quality of life in these individuals.Episodes of hypoglycaemia, fear of hypoglycaemia, change in life style and fearof long term consequences may lead to reduced health-related quality of life(HRQoL).  Diabetes mellitus is a chronic disease that can affect allaspects of life.

Diabetes self-management education (DSME) isrecognized as a fundamental component of diabetes care. and it is believedthat improving patient self-efficacy is a critical pathway to improvedself-management  The goal of DSME is to help patients acquire theknowledge, information, self-care practices, coping skills, and attitudesrequired for the effective self-management of their diabetes. Severalreviews and meta-analyses have found DSME interventions to have a positiveimpact on diabetes-related health and psychosocial outcomes, specificallyincreasing diabetes-related knowledge and improving blood glucose monitoring,dietary and exercise habits, foot care, medication taking, coping skills, andglycemic control.

The proposed study will be conducted in the health centresof the field practice areas under the Department of Community Medicine, HamdardInstitute of Medical Sciences and Research(HIMSR) and the Diabetic clinic,Department of  Medicine, HAHC Hospital,HIMSR.

The proposed study will be a Randomized controlledtrial. A total of 200 patients (diagnosed with type-2 diabetes mellitus will berandomized into two groups (100 patients each).

A baseline assessment of knowledge, self careactivities (by using SDSCA questionnaire) , Diabetes self-care efficacy( byusing Diabetes Management Self-Efficacy Scale (DMSES)), Qualityof life ( by using DMQoLquestionnaire)and glycemic control (HbA1C).

The intervention group will receive the diabetesself management education package alongwith the routine care while the controlgroup will receive the routine standard care.

Comparison of self care activities, self-careefficacy, quality of life and HbA1C measurements will be done at baseline andat 6 months in both the groups.

If the intervention proves useful, it may beextended to primary health centres and villages where health workers may betrained to provide structured education on diabetes self management.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Documented physician diagnosed type 2 diabetes for atleast 6 months Ability and willingness to provide informed consent (English or Hindi) No plans to move out of the area within the 12 month study period.

排除标准

  • Patients of Type 1 Diabetes Patients of Gestational Diabetes Patients having severe complications – like retinopathy or stroke Any use of glucocorticoid therapy within the past 3 months Patients currently participating in a cardiac rehabilitation or formal weight loss programme.

结局指标

主要结局

Glycemic Control and

时间窗: At baseline and | 6 months

Diabetes Self Care Activities

时间窗: At baseline and | 6 months

次要结局

  • Cardiovascular risk factor assessment(At baseline and)
  • Diabetes self-efficacy
  • Quality of life(At baseline and)

研究者

发起方
Hamdard Institute of Medical Sciences and Research
申办方类型
Private medical college

研究点 (2)

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