Trial Outcomes & Findings for Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women (NCT NCT04475718)

Last Updated: 2023-02-08

Results Overview

Measured by the Connor-Davidson Resilience Scale, a 25-item scale covering 17 domains related to resiliency, used with a variety of populations, across a wide range of languages, racial/ethnic, and cultural groups. It has strong psychometric properties and validated short forms. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-25, the full range is from 0 to 100, with higher scores reflecting greater resilience.

Recruitment status

COMPLETED

Study phase

Target enrollment

87 participants

Primary outcome timeframe

baseline, 4 weeks

Results posted on

2023-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Fourth Trimester Mobile Tool Fourth Trimester Mobile Tool Fourth Trimester Mobile Tool: A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.
Overall Study STARTED	87
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fourth Trimester - A Web-based Tool for Postpartum Care to Address the Needs of Underserved Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	87 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 4 weeks

Population: Analysis of change in outcome between baseline and after one-month will compare change in composite summary scale scores from pre-test to post-test for subjects in the ITT analysis set with data for both time points.

Outcome measures

Outcome measures
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Change From Baseline Resilience at 4 Weeks Baseline	26.57 score on a scale Interval 25.45 to 27.7
Change From Baseline Resilience at 4 Weeks 4 Weeks	28.29 score on a scale Interval 27.11 to 29.45
Change From Baseline Resilience at 4 Weeks Difference of Post and Pre Total Score for Connor-Davidson Resilience Scale	1.85 score on a scale Interval 0.92 to 2.78

SECONDARY outcome

Timeframe: baseline, 4 weeks

Population: 87 participants completed baseline. 79 participants completed the post-test at 4 weeks.

The Edinburgh Postnatal Depression Scale (EPDS) will be used to assess depressive symptoms. The 10-question Edinburgh Postnatal Depression Scale (EPDS) is a valuable and efficient way of identifying patients at risk for perinatal depression. Scores range from 0-30. Higher scores indicate more depressive symptoms. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.

Outcome measures

Outcome measures
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) Baseline	8.90 score on a scale Interval 7.74 to 10.05
Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) 4 Weeks	8.70 score on a scale Interval 7.56 to 9.83
Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) Difference of Post and Pre Total Score for Edinburgh Postnatal Depression Scale	-0.24 score on a scale Interval -1.21 to 0.73

SECONDARY outcome

Timeframe: baseline, 4 weeks

Population: 87 participants completed baseline. 79 participants completed the post-test at 4 weeks.

The MOS Social Support Survey will be used to assess overall social support and 4 subscales (Emotional/Informational Support; Tangible Support; Affectionate Support; Positive Social Interaction). The MOS Social Support Survey is a 19-item self-administered instrument. Items range from 1-5. The overall social support score is calculated as the mean response to all 19 items. Scores range from 19-95 with higher scores indicating more support.

Outcome measures

Outcome measures
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey 4 Weeks	3.64 score on a scale Interval 3.45 to 3.84
Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey Difference of Post and Pre overall summary score for MOS Social Support	-0.02 score on a scale Interval -0.17 to 0.12
Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey Baseline	3.67 score on a scale Interval 3.51 to 3.84

SECONDARY outcome

Timeframe: baseline, 4 weeks

Population: 87 participants completed baseline. 79 participants completed the post-test at 4 weeks.

The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety with 20 items for assessing trait anxiety and 20 for state anxiety. It has been validated for use with pregnant women. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. Higher scores indicate greater anxiety.

Outcome measures

Outcome measures
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Change From Baseline Parent Anxiety at 4 Weeks Baseline	41.44 score on a scale Interval 39.38 to 43.49
Change From Baseline Parent Anxiety at 4 Weeks 4 Weeks	40.87 score on a scale Interval 38.58 to 43.16
Change From Baseline Parent Anxiety at 4 Weeks Difference of Post and Pre Total score for State-Trait Anxiety Inventory	-0.82 score on a scale Interval -2.35 to 0.7

SECONDARY outcome

Timeframe: baseline, 4 weeks

Population: 87 participants completed baseline. 79 participants completed the post-test at 4 weeks.

The COVID-19 and Mental Health Impacts tool is a survey to help better understand how the novel coronavirus (COVID-19) pandemic is affecting people's emotional and mental health. A modified version of this instrument was used (removing Q1) to assess the impact of COVID-19 on study participants. All items are rated on a 5-point scale (from Strongly Disagree to Strongly Agree). The range of possible scores is 12-60, with higher scores indicating greater impact of COVID-19. The overall summary score is the sum of all items . While COVID-19 impact was not a formal endpoints, a descriptive analysis of this measure was conducted.

Outcome measures

Outcome measures
Measure	Pre-Post Comparison n=87 Participants Each participant was provided access to the Joyuus prototype for one month. Pilot participants were asked to complete a pretest, answer two real-time experience surveys while using the tool (visual identity and content), and complete a post-test one month after accessing the tool.
Change From COVID-19 and Mental Health Impacts at 4 Weeks Baseline	29.34 score on a scale Interval 27.34 to 31.35
Change From COVID-19 and Mental Health Impacts at 4 Weeks 4 Weeks	29.65 score on a scale Interval 27.55 to 31.74
Change From COVID-19 and Mental Health Impacts at 4 Weeks Difference of Post and Pre Total score for COVID-19 and Mental Health Impacts	0.03 score on a scale Interval -1.53 to 1.58

Adverse Events

Fourth Trimester Mobile Tool

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

Lisa Marceau

Orange Square Designs

Phone: 4014284197

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place