To develop and evaluate the effectiveness of multidisciplinary education and care model for individuals with diabetes affected with COVID-19: A two-arm parallel Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
Long-COVID is an entity in which patient can continue to have persistent or new-onset symptoms/complications after COVID-19, which can result in significant morbidity. Given the huge burden of diabetes in India and a large number of COVID-19 cases that the country has seen, the so called long COVID will be a major health concern in the near future and a potential action plan is needed to address it effectively. Given the gaps in knowledge about post COVID sequelae and their management/rehabilitation, particularly in the context of diabetes, it’s important to have a holistic multi-disciplinary education program which has ease of access, can be delivered remotely, including areas where patients have poor access to apex hospitals. With the intention of developing such a virtual comprehensive education program, and a multi-disciplinary patient care model, we propose this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Diabetes as defined by American Diabetes Association criteria History of confirmed COVID-19 in the past Age more than 18 years Registered in AIIMS hospital.
排除标准
- •Not willing to participate as per the study protocol.
结局指标
主要结局
Primary outcome
时间窗: 6 months
Achievement or maintenance of 3 out of these 5 individual goals at end of 6 months of the intervention phase
时间窗: 6 months
3.LDL less than 100 mg/dl
时间窗: 6 months
1.HbA1c equal to or less tha 7.0%
时间窗: 6 months
2.SBP less than 140 mm Hg and DBP 90 mm Hg
时间窗: 6 months
4.BMI less than 25 kg/m2
时间窗: 6 months
5.PHQ-9 less than 5
时间窗: 6 months
次要结局
- LDL less than 100 mg/dl(6 12 and 18 months)
- HbA1c equal to or less than 7.0%(6 12 and 18 months)
- Hypertension(6 12 and 18 months)
- BMI less than 25(6 12 and 18 months)
- PHQ 9 score less than 5(6 12 and 18 months)
