| CTRI Number |
CTRI/2019/08/021006 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
30/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Mobile application based health education] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How a mobile based application enabled counseling improves the quality of postnatal care which is provided after delivery and comparing this with the prior care |
|
Scientific Title of Study
|
Effect of Health Worker-led Home-Based Family-Level Counseling and Real-Time Monitoring of Service Delivery on Postnatal Anemia and Exclusive Breast Feeding in Health Centers of JIPMER, Puducherry, India – A Pre and Post design study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balachandiran |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Preventive and Social Medicine
4th Floor, Admin block, JIPMER
Puducherry- 605006
Department of Preventive and Social Medicine
4th Floor, Admin block, JIPMER
Puducherry- 605006
Pondicherry
PONDICHERRY
Puducherry- 605006
India |
| Phone |
08220338324 |
| Fax |
|
| Email |
balachandiran2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayalakshmy |
| Designation |
Associate Professor |
| Affiliation |
JIPMER |
| Address |
JIPMER Quarters
4th floor Admin block, Department of Preventive and Social Medicine,
JIPMER
Pondicherry
PONDICHERRY
Puducherry- 605006
India |
| Phone |
9944338145 |
| Fax |
|
| Email |
medico.jay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balachandiran |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Preventive and Social Medicine
4th Floor, Admin block, JIPMER
Puducherry- 605006
Department of Preventive and Social Medicine
4th Floor, Admin block, JIPMER
Puducherry- 605006
Pondicherry
PONDICHERRY
Puducherry- 605006
India |
| Phone |
08220338324 |
| Fax |
|
| Email |
balachandiran2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Dhanvantari Nagar, Puducherry- 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri Nagar
Puducherry- 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Balachandiran |
JIPMER |
JIPMER Urban health centre located in Kurusukuppam and JIPMER Rural health centre located in Ramanathapuram
Pondicherry
PONDICHERRY |
08220338324
balachandiran2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All the Antenatal mothers in the III Trimester who has decided to stay for 6 months after delivery in the service area of JIPMER will be enrolled after their written informed consent. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pre and Post study design |
The existing postnatal care in the service area will be compared after the intervention and the differences obtained in term of quality of care will be analysed |
| Intervention |
Pre and Post study design |
Training for the health worker for structured home-based family-level counselling on postnatal health and exclusive breast feeding. They will also be guided to use video for delivering conselling that is provided through the APP. They will be asked to use the APP to give a confirmation that they have delivered the counselling to the whole family members. They will also be educated on the real-time monitoring that happens in the APP (that the GPS location of the APP usage will be updated in the server, which gets automatically visible to all the people enrolled in the APP ). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All the third trimester mothers (≥18 years) registered under JIPMER Health centres of Puducherry, who have decided to stay in the same service for the next 6 months. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Postnatal mother adherent to IFA at 12 weeks (65% adherent): Yes or No.
2. Difference in Hb status from second week to twelth week in gm%
3. Children exclusively breastfed for 6 months: Yes or No
4. Duration of exclusive breast feeding: in months |
At the end of 3rd and 6th month after delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of postnatal home visits received by mother (counts)
2.Number of IFA tablets received by the mother at the first week (counts)
|
At the end of 6 months after delivery |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
03/09/2019 |
| 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="1"
Months="4"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After assessing the barriers for
adequate postnatal visits to be delivered by the health worker, by a
qualitative assessment, a training program will be conducted for the health workers from the selected PHCs. The
training will enable them to deliver structured counseling on importance of
Iron supplementation and exclusive breast feeding during postpartum. It will be
ensured that other family members in the family also participate in the counselling
session. Using a locally developed Application (APP), real-time monitoring will
also be done. The Adherence to IFA will be verified by pill count and Hb
estimation for Mothers will be done by the investigator during post
intervention at mother’s home. The APP will also enable the health workers to
send weekly SMS reminder to the mothers or/and to her spouse/family member to
encourage them regarding IFA tablet consumption and Exclusive Breast feeding
(EBF).After assessing the barriers for
adequate postnatal visits to be delivered by the health worker, by a
qualitative assessment, a training program will be conducted for the health workers from the selected PHCs. The
training will enable them to deliver structured counseling on importance of
Iron supplementation and exclusive breast feeding during postpartum. It will be
ensured that other family members in the family also participate in the counselling
session. Using a locally developed Application (APP), real-time monitoring will
also be done. The Adherence to IFA will be verified by pill count and Hb
estimation for Mothers will be done by the investigator during post
intervention at mother’s home. The APP will also enable the health workers to
send weekly SMS reminder to the mothers or/and to her spouse/family member to
encourage them regarding IFA tablet consumption and Exclusive Breast feeding
(EBF). |