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CTRI Number  CTRI/2022/05/042855 [Registered on: 27/05/2022] Trial Registered Prospectively
Last Modified On: 24/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Education program for individuals with diabetes affected with COVID-19 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashdeep Gupta 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 308, Biotechnology block, All India Institute of Medical Sciences, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  011-26593237  
Fax    
Email  yashdeep@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Yashdeep Gupta 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 308, Biotechnology block, All India Institute of Medical Sciences, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  011-26593237  
Fax    
Email  yashdeep@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Yashdeep Gupta 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No 308, Biotechnology block, All India Institute of Medical Sciences, New Delhi, Ansari Nagar

South
DELHI
110029
India 
Phone  011-26593237  
Fax    
Email  yashdeep@aiims.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research, Ansari Nagar, 110029, New Delhi 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yashdeep Gupta  AIIMS, Delhi  Department of Endocrinology and Metabolism, Room No 308, Biotechnology building
South
DELHI 		 01126593237

yashdeep@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Component A: Education package Component B: Care model   Intervention details: Component A: Education package The intervention package will comprise of video sessions (pre-recorded). This will help in the uniformity of delivery of contents, and further increase the scope of scalability and sustainability. The session content will be formulated under the supervision of principal and co-investigators who will lend their expertise in formulating these sessions. The content will be practical and will contain information required for an individual with diabetes. Language will be simple (in Hindi) and videos will be designed from point of scalability. Feedback collected from patients during the initial formative phase will be used to improve the health education package. The sessions will be delivered through a web-based platform by trained staff, which will involve Diabetes educator, clinical psychologist, dietician and physiotherapist. Each session will comprise of 30-45 minutes of content and 15-30 minutes of interaction and will be delivered in batches of 6-12. A total of 8 sessions are planned for each patient, with one session/week, and intervention phase is for 6 months Since, the intervention is virtual, we have the flexibility of delivering the sessions separately also for the participants who are unable to take the sessions at the given date and time. All efforts will be made to deliver all content of intervention as far as possible. Component B: Care model Proposed care model: In this care model, clinicians from multiple specialties are involved, who will help in designing a care model, where simple problems can be dealt at first place, minimizing need of cross-department consultations. Where required, consultation will be facilitated within 10 days for those in need. We will evaluate the impact of this model on patient outcomes. If the impact of this care model improves patient outcomes, then with the help of Hospital administration (two on board), a way of incorporating this care model at hospital level will be tried.  
Comparator Agent  Enhanced Usual Care  Facilitated appointments at baseline, 6, 12 and 18 months with Endocrinologist 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  Not willing to participate as per the study protocol 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome

Achievement or maintenance of 3 out of these 5 individual goals at end of 6 months of the intervention phase

1. HbA1c equal to or less tha 7.0%
2. SBP less than 140 mm Hg and DBP 90 mm Hg
3. LDL less than 100 mg/dl
4. BMI less than 25 kg/m2
5. PHQ-9 less than 5

 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
HbA1c equal to or less than 7.0%   6 12 and 18 months 
Hypertension   6 12 and 18 months 
LDL less than 100 mg/dl   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 
 
Target Sample Size   Total Sample Size="415"
Sample Size from India="415" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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, 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. 

 
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