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临床试验/CTRI/2024/06/068594
CTRI/2024/06/068594已完成2/3 期

Effect of patients education regarding appropriate insulin injection practices using skin pad on glycemic status among diabetic patients who self administer insulin in a primary care setting A community based Quasi experimental study

Dr Vaitheswari A1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Glycaemic status(HbA1C) improves post intervention

研究概览

简要总结

The study is planned to be conducted in 2 health and wellness centres (HWC) namely Mettupalayam (Control group) and Lawspet() Intervention group with diabetic patients on insulin who are enrolled in NCD clinic with sample size of 80 i.e 40 in each group. Injection technique assessment will be done for both the groups at baseline and at 6th month. Intervention group will be provided with standard injection technique education using video, flipbook, posters and HbA1c will be checked for both the groups at baseline, 3rd month and at 6th month and compared to find the effectiveness of education intervention. Among participants from both the groups who have achieved satisfactory and unsatisfactory glycaemic control in depth interview will be conducted to explore the reason for the same.

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
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Type I and type II diabetic patients above 18years of age and who are enrolled in NCD clinic at HWC Patients who are on insulin for atleast 6months Patients who self administers insulin Patient who gives consent.

排除标准

  • Gestational diabetes Patients who are on insulin pens Terminally ill patients who are not able to participate in the study Self reported Haemoglobinopathies, CKD and chronic liver disease Patient who are not able to comprehend or have cognitive impairment Patient who are not available in the house for 3 consecutive visits.

结局指标

主要结局

Glycaemic status(HbA1C) improves post intervention

时间窗: At baseline, 12 weeks and 6th month

次要结局

  • Incidence of lipohypertrophy, glycaemic variabiity, change in insulin dosage, injection related adverse events(At baseline & 6th month)

研究者

发起方
Dr Vaitheswari A
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vaitheswari A

Indira Gandhi Medical college and Research institute

研究点 (1)

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