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CTRI Number  CTRI/2025/12/099952 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 28/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Other (Specify) [Introduction of joint clinics for transition of patients from pediatric to adult endocrine services]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to compare the effect of joint clinics versus usual care in transition of patients from pediatric to adult endocrine services 
Scientific Title of Study   Joint clinics versus usual care for transition from pediatric to adult endocrine services: A ranomized control trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanupriya 
Designation  Senior Resident (DM Pediatric Endocrinology) 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room No. 563, 5C ward, 5th floor, Mother and Child Block Division of Pediatric Endocrinology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  9466156208  
Fax    
Email  kanulhmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kanupriya 
Designation  Senior Resident (DM Pediatric Endocrinology) 
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room no. 563, 5C ward, 5th floor, Mother and Child Block Division of Pediatric Endocrinology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  9466156208  
Fax    
Email  kanulhmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Vandana Jain  
Designation  Professor, Department of Pediatrics  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room no. 819, 8th floor, Mother and Child Block, All India Institute of Medical Sciences, New Delhi 110029

South
DELHI
110029
India 
Phone  9810167265  
Fax    
Email  drvandanajain@aiims.edu  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi 110029 
 
Primary Sponsor  
Name  Kanupriya 
Address  5C ward, 5th floor, Mother and Child Block, All India Institute of Medical Sciences, New Delhi 110029 
Type of Sponsor  Other [SELF] 
 
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 
Dr Kanupriya  AIIMS  Room no. 563, 5C ward, 5th floor, Mother and Child Block, Division of Pediatric Endocrinology, Department of Pediatrics, AIIMS, New Delhi
South
DELHI 		 9466156208

kanulhmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Joint clinics  Two joint clinics (attended by both pediatric and adult endocrine specialists) 3-6 months apart for transition of patients from pediatric to adult endocrine services 
Comparator Agent  Usual care  Direct transfer of patients from pediatric to adult endocrine services 
 
Inclusion Criteria  
Age From  16.50 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Patients aged more than 16.5 years with chronic endocrine condition, needing continuation of endocrine follow-up, if the patient clears the readiness assessment
 
 
ExclusionCriteria 
Details  Patients following up under Pediatric Endocrinology services for less than 1 year
The pediatric endocrine care provider wants to defer transition either due to concerns of pending diagnostic work-up or treatment decisions, because they feel that the patient should continue follow-up under Pediatric Endocrinology for some more time
Patient is unwilling to continue follow-up at AIIMS, New Delhi for any reason
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients attending at least 2 scheduled adult endocrine OPD visits   During 12 months after completion of transition/ transfer 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the enabling factors and challenges perceived by patients during the change from pediatric to adult endocrine services using a pre designed questionnaire.

 		 12 months post transition/ transfer 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   12/01/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is an open-label two-arm randomized control trial comparing joint clinics versus usual care (direct transfer) for the transition of patients from pediatric to adult endocrine services. Patients aged 16.5 years or older who are following up at pediatric endocrine services will be enrolled after a readiness assessment. Enrolled patients will be randomly allocated to either of the two arms. All the patients will undergo primary and secondary outcome assessment during a 12-month follow-up.  
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