CTRI/2024/12/077527尚未招募不适用
Influence of Interprofessional Educational (IPE) Module for Enhancing Foot Care among Individuals with Type – 2 Diabetes Mellitus
Dr Bhukya Nom Kumar Naik1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年11月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Enhancing in glycemic parameters (HbA1C or RBS).
研究概览
简要总结
Summary of the Study with 6 Steps
- Enrolment: Participants are enrolled using strict inclusion/exclusion criteria. Demographic data is collected, and a pre-test is conducted to assess knowledge and practices related to diabetic foot self-management.
- Allocation: Participants are randomly assigned to an Interventional Group or Control Group using a coin-toss method. The study is conducted across various healthcare settings like endocrinology, surgery, and physiotherapy.
- Intervention: The Interventional Group receives a structured intervention as proposed outlined in Protocol submitted to IEC.
- Follow-up: The researcher coordinates with healthcare professionals to address issues and maintains regular communication with participants for six months.
- Data Collection: Data is gathered pre- and post-intervention, including knowledge and practice scores, glycaemic values (HbA1c and RBS), and foot assessments from CDFCR. Financial support is provided to economically constrained participants.
- Analysis: Statistical analysis is performed using paired t-tests with software like SPSS V27 or Jamovi to evaluate the module’s impact on knowledge, behavior, and clinical outcomes. Findings will be published.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18–80 with Type 2 Diabetes Mellitus (T2DM).
- •The individuals who will give consent.
- •Individuals who have had T2DM for at least 6 months.
- •Those with the ability to provide self care.
- •Diabetic individuals with different glycemic levels (HbA1c) or Increased RBS levels (As per WHO references)
- •Individuals with a high risk of developing DFU (Known cases of diabetic neuropathy, Diabetic Ischemia, and both Diabetic Neuropathy and ischemia)
- •Individuals with the ability to understand and communicate in either the Kannada or English language.
- •Participants are comfortable using social media tools like WhatsApp or other social media tools.
排除标准
- •Adults diagnosed with Type – 1 Diabetes, impaired fasting glucose, impaired glucose tolerance,
- •Gestational diabetes (Altered Insulin Production).
- •Patients with Recent or heavy blood loss.
- •Patients who developed foot ulcers or with any other form of foot deformity.
- •Individuals with a cognitive/speech impairment.
- •Those with an attention deficit.
- •Individuals facing mental challenges or disabilities.
- •Those with physical challenges or disabilities.
- •Individuals with an inability to mobilize.
结局指标
主要结局
Enhancing in glycemic parameters (HbA1C or RBS).
时间窗: Baseline, 4th week, 3rd Month and 6th Month
Enhancement in diabetic foot care practices through interprofessional education.
时间窗: Baseline, 4th week, 3rd Month and 6th Month
Decrease in diabetic foot complications.
时间窗: Baseline, 4th week, 3rd Month and 6th Month
Enhanced Diabetic foot self-reported practices
时间窗: Baseline, 4th week, 3rd Month and 6th Month
次要结局
- Not Applicable(Not applicable)
研究者
Dr Bhukya Nom Kumar Naik
Kasturba Medical College Manipal
研究点 (1)
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