| CTRI Number |
CTRI/2022/02/039896 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving the effectiveness of client support services with the use of artificial intelligence for users of a mobile phone based health education programme for maternal and child health. |
|
Scientific Title of Study
|
Randomised control trial to evaluate of the effectiveness of deploying an AI model using predictive analysis in reducing non-engagement among mMitra subscribers |
| Trial Acronym |
AIMMITRA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Madhiwalla |
| Designation |
Research Director |
| Affiliation |
ARMMAN |
| Address |
2nd Floor, Advance House, ARK Industrial Estate, Gamdevi, Marol, Andheri, Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9892220160 |
| Fax |
|
| Email |
nmadhiwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Madhiwalla |
| Designation |
Research Director |
| Affiliation |
ARMMAN |
| Address |
2nd Floor, Advance House, ARK Industrial Estate, Gamdevi, Marol, Andheri, Mumbai
Mumbai (Suburban)
MAHARASHTRA
4000059
India |
| Phone |
9892220160 |
| Fax |
|
| Email |
neha@armman.org |
|
Details of Contact Person
Public Query
|
| Name |
Neha Madhiwalla |
| Designation |
Research Director |
| Affiliation |
ARMMAN |
| Address |
2nd Floor, Advance House, ARK Industrial Estate, Gamdevi, Marol, Andheri, Mumbai
Mumbai (Suburban)
MAHARASHTRA
4000059
India |
| Phone |
9892220160 |
| Fax |
|
| Email |
neha@armman.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Google India Pvt Ltd |
| Address |
RMZ Infinity, Tower E, 4th Floor, Old Madras Road Bangalore 560 016, India |
| Type of Sponsor |
Other [IT Corporation] |
|
|
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 |
| Neha Madhiwalla |
ARMMAN |
mMitra programme division, Room No 1, Advance House, ARK Industrial Estate, Marol, Andheri (east), Mumbai 400059
Mumbai (Suburban)
MAHARASHTRA |
9892220160
neha@armman.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Board, ARMMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Women and Mothers of Infants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Current Standard of Care |
Subscribers invoking a service call by utilising a missed call service over a period of 8 weeks |
| Intervention |
RMAB |
Selection of subscribers for receiving service call based on predictive analysis AI model (RMAB) over a period of 8 weeks |
| Comparator Agent |
Round Robin |
Consecutive Subscribers called as per their date on enrolment over a period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
All active subscribers of mMitra automated voice messaging service. These are pregnant women and mothers of infants who have been enrolled for the mMitra service for 30-120 days on the start date of the study |
|
| ExclusionCriteria |
| Details |
All subscribers opting out of the service during the course of the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subscribers who engage (pick up at least one call and listen for more than 30 seconds) within each group |
Proportion of subscribers who engage (pick up at least one call and listen for more than 30 seconds) within each group at baseline, at the end of each week and cumulatively at the end of 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of service calls successfully received |
Weekly for 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="10800"
Sample Size from India="10800"
Final Enrollment numbers achieved (Total)= "12000"
Final Enrollment numbers achieved (India)="12000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2022 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The intervention being tested is an AI based solution which uses system-generated data and secondary data from the enrolment and client support processes. The objective of the project is to devise a more efficient and effective strategy for selecting subscribers to receive service calls. This human subject involvement in this project is in the delivery of service calls, which is a regular part of the mMitra service and is not the experimental component of the study. |