| CTRI Number |
CTRI/2018/11/016440 [Registered on: 27/11/2018] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
early identification of children with developmental delay in villages through trained ASHAs and Anganwadi workers |
|
Scientific Title of Study
|
Evaluating the effectiveness of a structured training module in detecting children with developmental delays in a rural setting of Odisha ; A Cluster Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR G Susmita Dora |
| Designation |
Junior Resident |
| Affiliation |
All Indian Institute of Medical Scienes, Bhubaneswar |
| Address |
Bio-informatics Room
Department of Community Medicine and Family Medicine
AIIMS, Bhubaneswar
Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
8093456022 |
| Fax |
|
| Email |
susmitadora90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR G Susmita Dora |
| Designation |
Junior Resident |
| Affiliation |
All Indian Institute of Medical Scienes, Bhubaneswar |
| Address |
Bio-informatics Room
Department of Community Medicine and Family Medicine
AIIMS, Bhubaneswar
Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
8093456022 |
| Fax |
|
| Email |
susmitadora90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Bhatia |
| Designation |
Professor and Head of Department |
| Affiliation |
All Indian Institute of Medical Scienes, Bhubaneswar |
| Address |
Department of Community Medicine and Family Medicine
AIIMS, Bhubaneswar
Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
9438884000 |
| Fax |
|
| Email |
bhatiaaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded(investigator bears all expenses)
Dr G.Susmita Dora
Junior Resident
Department of Community
Medicine & Family Medicine
AIIMS, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Dr G Susmita Dora |
| Address |
room no-609, PG-2 Hostel
AIIMS, Bhubaneswar
sijua, patrapada
751019
dist-khurdha
Bhubaneswar, Odisha |
| Type of Sponsor |
Government medical college |
|
|
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 Susmita Dora |
Community Health Center,Tangi |
Tangi Block
district- Khurdha
Bhubaneswar
Khordha
ORISSA |
8093456022
susmitadora90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frontline Workers(Anganwadi workers ans ASHA) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
training for detection of developmental delays in under 5 children |
structured training of frontline workers for early and accurate detection of developmental delays in children less then 5 years of age |
| Comparator Agent |
usual process of care under programme |
usual process of screening children by RBSK Mobile Health team |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
all children in the sector selected for intervention |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| number of children detected with developmental delays by frontline workers |
baseline and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| number of children detected with developmental delay by the investigator |
after intervention |
|
|
Target Sample Size
|
Total Sample Size="780"
Sample Size from India="780"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="113" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/02/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Developmental delay is when a child does not achieve his/her developmental milestones at the expected time. Rashtriya Bal Swasthya Karyakram (RBSK) was launched in february 2013 for early detection and management of 4Ds i.e. Defects at birth, Diseases, Deficiencies, Developmental Delays including Disabilities prevalent in children from 0 to 18 years of age.
RBSK doctors have huge work load and it is mandatory for them to visit each school atleast once in a year and AWCs atleast twice a year besides arranging for their follow up visits, various documentation and meetings etc. . It would be easier if certain children are already screened by FLWs between their visits that would allow quality time for high suspicion subjects. Since Anganwadi Workers are responsible for health status recording of children from 6 weeks to 6 years of age and helped by ASHAs in Village Health and Nutrition Day, these functionaries are ideally suited for screening of children with developmental delays.
In our study we would like to explore a strategy that would use these workers effectively in hope to detect children with Developmental Delays and make them available for advice of RBSK doctors. |