The Development and Feasibility of a Self Management intervention in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NIMHANS
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- self care, metabolic control, quality of life
研究概览
简要总结
The aim of the study is to develop a diabetes self management intervention and examine its feasibility and impact on improving self care, metabolic control and quality of life in patients with type 2 Diabetes Mellitus. A coping skills intervention, focusing on addressing self care and emotional issues in diabetes was designed. The study employs a randomized control design in which the self management intervention be carried out on a sample of 60 patients. Patients will be recruited from a general hospital setting and randomized to either an intervention group or a treatment as usual group. Assessments on illness perceptions, mood, self care, metabolic control and diabetes specific quality of life will be made at baseline, post therapy and 3 months follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Primary diagnosis of type 2 Diabetes Mellitus 2.Age between 30- 65 years 3.Duration of illness of at least 1 year 4.Working knowledge of English/ Hindi/ Kannada 5.Patients with HbA1c in the range of 7.5 to 10.
排除标准
- •Comorbid psychiatric condition in the patient Comorbid substance use amounting to dependence Cases of gestational diabetes, Cases of drug induced diabetesKnown cases of myocardial infarction and cerebrovascular illness The presence of significant microvascular complications such as amputations, end stage renal disease, and retinopathy Participants who have received structured psychological intervention in the last one year.
结局指标
主要结局
self care, metabolic control, quality of life
时间窗: baseline, post and 3 month followup
次要结局
- illness perception, mood(baseline, post and 3 month followup)