Trial Outcomes & Findings for Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2 (NCT NCT04693585)
NCT ID: NCT04693585
Last Updated: 2024-06-12
Results Overview
Number of participants reporting being "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
6 months
Results posted on
2024-06-12
Participant Flow
Participant milestones
| Measure |
Arm 1: Synchronous and Asynchronous Support
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
120
|
40
|
41
|
|
Overall Study
COMPLETED
|
94
|
28
|
13
|
|
Overall Study
NOT COMPLETED
|
26
|
12
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development and Pilot Test of a Postnatal mHealth Intervention - Phase 2
Baseline characteristics by cohort
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=120 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=40 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
n=41 Participants
Other: Standard of postnatal care.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
26.1 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
26.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Indian
|
120 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
201 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
120 participants
n=5 Participants
|
40 participants
n=7 Participants
|
41 participants
n=5 Participants
|
201 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Control group participants did not answer questions about intervention experience
Number of participants reporting being "satisfied" or "very satisfied" with their overall intervention experience, assessed through a five-point Likert scale at six months.
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=94 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=28 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants Reporting Being Satisfied or Very Satisfied About Their Overall Intervention Experience
|
90 Participants
|
19 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Group call intervention activities only relevant to arm 1.
Number of participants who engaged in weekly group call intervention activities by 6 months
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=120 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants Engaging in Group Call Intervention
|
37 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants correctly identifying at least 80% of knowledge on maternal and neonatal danger signs, best practices for infant care, and family planning at 6 months.
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=94 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=28 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
n=13 Participants
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants With Knowledge on Maternal and Neonatal Danger Signs, Best Practices for Infant Care, Family Planning.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who exclusively breastfed their infants through 6 months of age
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=94 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=28 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
n=13 Participants
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants Exclusively Breastfeeding
|
79 Participants
|
18 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants reporting postpartum depression symptoms at six months
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=94 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=28 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
n=13 Participants
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants Reporting Postpartum Depression
|
43 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants who started a modern contraceptive methods within 6 months postpartum
Outcome measures
| Measure |
Arm 1: Synchronous and Asynchronous Support
n=94 Participants
Synchronous: Real-time live voice or video call Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 2: Asynchronous Support
n=28 Participants
Asynchronous: Audio-based education via mobile application or interactive voice response on-demand Other: standard of postnatal care
|
Arm 3: Control
n=13 Participants
Other: Standard of postnatal care.
|
|---|---|---|---|
|
Number of Participants Who Adopted Postpartum Family Planning
|
67 Participants
|
14 Participants
|
10 Participants
|
Adverse Events
Arm 1: Synchronous and Asynchronous Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Asynchronous Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nadia Diamond-Smith
University of California San Francisco
Phone: 415-353-4545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place