| CTRI Number |
CTRI/2021/04/032739 [Registered on: 12/04/2021] Trial Registered Prospectively |
| Last Modified On: |
09/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Culturally tailored education module for type 1 diabetes. |
|
Scientific Title of Study
|
Development and Validation of a culturally tailored education module for type 1 diabetes in a resource constrained setting |
| Trial Acronym |
CTEM trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Latika Rohilla |
| Designation |
Public Health Nursing Officer |
| Affiliation |
PGIMER |
| Address |
Advanced Pediatrics Centre,
PGIMER, CHandigarh
SECTOR 12
Chandigarh
CHANDIGARH
134116
India |
| Phone |
09876143416 |
| Fax |
|
| Email |
swati.rohilla19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devi Dayal |
| Designation |
Professor and Unit Head |
| Affiliation |
PGIMER |
| Address |
Endocrinology and Diabetes Unit, Advanced Pediatrics Centre,
PGIMER, CHandigarh
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9872072472 |
| Fax |
|
| Email |
drdevidayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Latika Rohilla |
| Designation |
Public Health Nursing Officer |
| Affiliation |
PGIMER |
| Address |
Advanced Pediatrics Centre,
PGIMER, CHandigarh
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876143416 |
| Fax |
|
| Email |
swati.rohilla19@gmail.co |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Latika Rohilla |
| Address |
Advanced Pediatrics Centre, PGIMER,Chandigarh |
| Type of Sponsor |
Other [Investigator funded by self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devi Dayal |
Advanced Pediatrics Centre |
Endocrinology Ward and Counselling room (room no. 4408), Level 4, Advanced Pediatrics Centre, PGIMER
Chandigarh
CHANDIGARH |
9872072472
drdevidayal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Culturally tailored Diabetes Education |
Routine Diabetes care along with the developed intervention.
This includes counselling and education on various aspects of diabetes management as per the cultural practices of the participants)
The detailed plan of the intervention is as follows:
1. one hour lecture-cum-discussion session by a diabetes educator nurse, daily till discharge from hospital.(Educational Aids: Powerpoint presentation, Pictorial Booklet, diabetes diet chart)
2. Group discussion session among parents (of children with type 1 diabetes) for half an hour daily till discharge |
| Comparator Agent |
Routine Diabetes care |
It includes delivering instructions for management of child with Type 1 diabetes at home. (Lecture method: half an hour session daily till discharge from hospital. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Parents and children
1. Age of the child is less than 13 years.
2. Able to speak Hindi/Punjabi/English.
3. Willing to give written assent/consent for participation.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria: Parents and children
1. Child has any other life threatening disease which can affect the quality of life such as cancer, mental retardation, developmental disorders, etc.
2. Parent accompanying the child has any intellectual/visual/auditory disability with a medical diagnosis for the same
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1C |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinical outcomes (e.g., blood glucose measurements, Diabetic ketoacidosis and severe hypoglycaemia, BMI and weight etc.)
2. Psychosocial outcomes (e.g. diabetes-related quality of life, treatment satisfaction, diabetes related knowledge and self-efficacy etc.) |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/04/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SUMMARY OF PROTOCOL Development and Validation of a culturally tailored education module for type 1 diabetes in a resource constrained setting At present there is no validated diabetes education program for the parents of children with type 1 diabetes who have resource constraints anywhere in the world. Thus, there is a dire need of a validated educational program for parents with poor literacy and numeracy skills, especially in low resource settings like India, where financial constraints already cause a huge risk for poor adherence to insulin regimens. Whereas the financial constraints cannot be tackled immediately, modifying the existing educational programs to ensure better understanding and reduce risk of mismanagement by empowering the unlettered parents can be a big turning stone in the type 1 Diabetes management in a multicultural society as India is. Therefore, we aim to develop and validate a culturally tailored education module for type 1 diabetes in a resource constrained setting, to assess the clinical outcomes, glycemic control (primary outcome), Quality of life (Secondary outcome), treatment satisfaction, diabetes related acceptance, empowerment, family dysfunction, family impact and psychosocial burden of the school going children and their parents related to this chronic condition at baseline, 3 months and 6 months post intervention using a quasi-experimental design. |