Development and Validation of a culturally tailored education module for type 1 diabetes in a resource constrained setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- HbA1C
研究概览
简要总结
SUMMARY OF PROTOCOL
Development and Validation of a culturally tailored education module for type 1 diabetes in a resource constrained setting
At present there is no validated diabetes education program for the parents of children with type 1 diabetes who have resource constraints anywhere in the world. Thus, there is a dire need of a validated educational program for parents with poor literacy and numeracy skills, especially in low resource settings like India, where financial constraints already cause a huge risk for poor adherence to insulin regimens. Whereas the financial constraints cannot be tackled immediately, modifying the existing educational programs to ensure better understanding and reduce risk of mismanagement by empowering the unlettered parents can be a big turning stone in the type 1 Diabetes management in a multicultural society as India is.
Therefore, we aim to develop and validate a culturally tailored education module for type 1 diabetes in a resource constrained setting, to assess the clinical outcomes, glycemic control (primary outcome), Quality of life (Secondary outcome), treatment satisfaction, diabetes related acceptance, empowerment, family dysfunction, family impact and psychosocial burden of the school going children and their parents related to this chronic condition at baseline, 3 months and 6 months post intervention using a quasi-experimental design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 13.00 Year(s)（—）
- 性别
- All
入选标准
- •Parents and children 1.Age of the child is less than 13 years.
- •2.Able to speak Hindi/Punjabi/English.
- •3.Willing to give written assent/consent for participation.
排除标准
- •Exclusion Criteria: Parents and children 1.Child has any other life threatening disease which can affect the quality of life such as cancer, mental retardation, developmental disorders, etc.
- •2.Parent accompanying the child has any intellectual/visual/auditory disability with a medical diagnosis for the same.
结局指标
主要结局
HbA1C
时间窗: Baseline, 3 months, 6 months
次要结局
- 1.Clinical outcomes (e.g., blood glucose measurements, Diabetic ketoacidosis and severe hypoglycaemia, BMI and weight etc.)(2.Psychosocial outcomes (e.g. diabetes-related quality of life, treatment satisfaction, diabetes related knowledge and self-efficacy etc.))