Education program for individuals with diabetes affected with COVID-19

Phase 3

Not yet recruiting

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2022/05/042855

Lead Sponsor: Indian Council of Medical Research

Brief Summary: 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, itâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 415

Inclusion Criteria

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.

Exclusion Criteria

Not willing to participate as per the study protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement or maintenance of 3 out of these 5 individual goals at end of 6 months of the intervention phase	6 months
Primary outcome	6 months
3.LDL less than 100 mg/dl	6 months
1.HbA1c equal to or less tha 7.0%	6 months
2.SBP less than 140 mm Hg and DBP 90 mm Hg	6 months
4.BMI less than 25 kg/m2	6 months
5.PHQ-9 less than 5	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS, Delhi
🇮🇳
South, DELHI, India
AIIMS, Delhi
🇮🇳South, DELHI, India
Yashdeep Gupta
Principal investigator
01126593237
yashdeep@aiims.edu