跳至主要内容
临床试验/CTRI/2022/05/042855
CTRI/2022/05/042855尚未招募3 期

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

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 415 人开始时间: 2022年1月7日最近更新:

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)

研究者

申办方类型
Government funding agency

研究点 (1)

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