跳至主要内容
临床试验/CTRI/2023/11/060294
CTRI/2023/11/060294尚未招募不适用

Effectiveness of a Structured Diabetes Education Package among Patients with Type 2 Diabetes Attending an Urban Health Centre in East Delhi

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Mean change in diabetes self-care activities after administration of intervention among the study subjects at the end of the study.

研究概览

简要总结

Diabetes Self-Management Education and Support (DSME/S) is an evidence-based, cost-effective package to facilitate informed self-management and decision-making for people with diabetes. There are significant gaps in people’s knowledge about diabetes, which can adversely affect motivation for treatment and self-care adherence. Improvement in self-care activities can reduce the chance of developing complications and early mortality. Access to locally adapted self-management education can change patients’ attitudes about their disease, medication and self-care activities.

 There is a dearth of studies on the effect of self-management education on diabetes management in India. This study is an attempt to find the effect of a diabetes self management education interventional package on the self care activities among patients with type 2 diabetes. This will help us understand the impact of such a low-cost intervention and understand the feasibility of its implementation in the longer term.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with type 2 diabetes under treatment at UHC Kalyanpuri for at least six months.

排除标准

  • Pregnant women, Patients with Type 2 diabetes on insulin therapy, Patients with chronic complications which hinder self care activities (eg diabetic foot, advanced diabetic retinopathy, advanced diabetic nephropathy), Patients unable to communicate for any reason.

结局指标

主要结局

Mean change in diabetes self-care activities after administration of intervention among the study subjects at the end of the study.

时间窗: at baseline, 3 months and 6 months.

次要结局

  • Mean change in clinical outcomes, viz, FBS, HbA1c, skin-fold thickness among the study subjects.(at baseline, 3 months & 6 months.)
  • Proportion of study subjects who perceive the education package as useful.(at baseline, 3 months & 6 months.)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Radhikaa Sharma

Lady Hardinge Medical College

研究点 (1)

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