Impact of a comprehensive self care education module on diabetes management: a community based cluster randomized cross over trial in Puducherry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Improvement in mean hba1c levels after self care intervention
研究概览
简要总结
Title: Impact of a comprehensive self care education module on diabetes management : A community based cluster randomized cross over trial in Puducherry
Primary objective: To assess the effect of a structured self care education module on the glycemic control among diabetic patients at rural and urban field
Secondary objective:
**1.**To estimate the level of self care practices among diabetic patients at urban and rural field practice area
2.To explore the barriers and facilitators in adhering to good diabetic self care practices among the diabetics.
Methodology of the research work:
Setting: Rural and Urban field practice areas of AVMCH
Study design: community based, cluster randomized controlled trial – (stepped wedge design) single arm cross over model
Study participants: Diabetics attending to the rural and urban field practice areas of AVMC&H, Puducherry.
Study duration: 2023-2025
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Duration of disease: Six months and more
- •Treatment: On Oral hypoglycemic drugs or on insulin
- •Age: 18 years and above.
排除标准
- •Bedridden patients
- •Gestational diabetes.
结局指标
主要结局
Improvement in mean hba1c levels after self care intervention
时间窗: Baseline - 3months-6 months
次要结局
- . The self care module developed at the end of FGD can be used to educate diabetic patients even after the study.(At the baseline, after 3 months & after 6 months)
研究者
DR J VARSHA
Aarupadai veedu medical college and hospital