| CTRI Number |
CTRI/2024/05/067951 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of psychological and dietary counseling on the behavior of children with Type-1 Diabetes Mellitus.
|
|
Scientific Title of Study
|
Effect of a Multidomain Intervention on the Behaviour Problems and Cognition in children with Hypoglycemia Unawareness in Type-1 Diabetes Mellitus-A Pilot Study
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sangeetha Merrin Varghese |
| Designation |
Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala |
| Affiliation |
Believers Church Medical College Hospital, Kerala |
| Address |
Believers Church Medical College Hospital
St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala
Pathanamthitta KERALA 689103 India |
| Phone |
9447777012 |
| Fax |
|
| Email |
sangjithin2011@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sangeetha Merrin Varghese |
| Designation |
Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala |
| Affiliation |
Believers Church Medical College Hospital, Kerala |
| Address |
Believers Church Medical College Hospital
St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala
Pathanamthitta KERALA 689103 India |
| Phone |
9447777012 |
| Fax |
|
| Email |
sangjithin2011@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sangeetha Merrin Varghese |
| Designation |
Associate Professor, Dept. of Community Medicine , Believers Church Medical College, Kerala |
| Affiliation |
Believers Church Medical College Hospital, Kerala |
| Address |
Believers Church Medical College Hospital
St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala
Pathanamthitta KERALA 689103 India |
| Phone |
9447777012 |
| Fax |
|
| Email |
sangjithin2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| PRIIIA, St. Johns Hospital, Bangalore, India
Pin: 560034 |
|
|
Primary Sponsor
|
| Name |
Psychiatric Research Infrastructure for Intervention and Implementation in India (PRIIIA) |
| Address |
St. Johns Medical College
Sarjapur - Marathahalli Rd, beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Fogarty International |
University of Pittsburg, USA |
| NIH |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangeetha Merrin Varghese |
Believers Church Medical College |
Dept. of Community Medicine, Research Lab,
Believers Church Medical College Hospital
St. Thomas Nagar, Kuttapuzha, Thiruvalla, Kerala 689103 Pathanamthitta KERALA |
9447777012
sangjithin2011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Believers Church Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E108||Type 1 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multi-Domain Intervention |
Psychological Counselling
Dietary Management Disease
self Management Training for 6 months with 2 monthly follow up |
| Comparator Agent |
Standard Treatment or
Treatment as Usual |
Dietary education by Diabetic Educator |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children must be on treatment with Insulin for a minimum period of 6
months |
|
| ExclusionCriteria |
| Details |
Children with known psychiatric disorders.
Children with known intellectual disability |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Behavior and cognition in children with TYpe-1
DM before and after Multi-domain interventions. |
Behavior and cognition in children with TYpe-1
Diabetes Mellitus at the start of the study and at the end of 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Hypoglycemia Unawareness |
at the end of the screening 2-3 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The bigger study on the same topic with the WISC-4 Cognition assessment tool, more objectives, larger sample size and 2 year long study has been approved by CTRI (CTRI/2024/03/063628). This will be a pilot study on only 44 patients, using readily available cognition assessment tool (Modified Mini-Mental State Examination) and for a shorter duration of 6 months.
I would like to focus on Behavioral and Cognitive Functions in Children with Young Onset Diabetes Mellitus (predominantly Type-1 Diabetes Mellitus) with a special interest in those who have Hypoglycemia Unawareness or Impaired Awareness of Hypoglycemia. I would like to implement certain structured interventions which could be beneficial in preventing behavioral and cognitive decline in such children. If these interventions prove to be beneficial, we would implement screening for Hypoglycemia Unawareness, Behavioral Screening, and Cognitive Screening for all children with Young Onset Diabetes Mellitus and then provide them with tailored interventions in the form of Psychotherapy for Children and Parents, Diabetes Education and Dietary Interventions. All these interventions when given to children and their parents in a structured, regular, and balanced manner would reduce behavioral problems and cognitive decline. The Govt. of India and ICMR have initiated steps to curb Type-1 Diabetes. It also established a registry in 2006 named the Young Diabetes Registry. The Govt. of Kerala has started the ‘MITTAYI’ program for early identification, comprehensive treatment and all necessary support for children and Adolescents with Type-1 Diabetes Mellitus. So, if our work proves to be beneficial, we can incorporate our early intervention strategies to tackle behavioral and cognitive problems in all such children, at the State level. |