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| ID | Type | Description | Link |
|---|---|---|---|
| R43MD014923 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Orange Square Design, Inc. | INDUSTRY |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The postpartum period is a critical time for both maternal and child health, and more than half of all maternal deaths occur postpartum, from one day to one year after birth. This poor outcome is linked to the racial and ethnic disparities that disproportionately effects low income and black women. To reduce the burden of the postpartum period for this population, the goal of this project is to develop an accessible, targeted online tool designed to address the needs of underserved women who are at greater risk for adverse postpartum outcomes by providing the appropriate tools, knowledge and skills to improve postpartum health.
In the United States, the postpartum period is a critical time for both maternal and child health, the mortality rate is the highest among other developed, high income countries and more than half of all maternal deaths occur postpartum, from one day to one year after birth. This poor outcome is linked to the racial and ethnic disparities that disproportionately effect black women who are 3-4 times more likely to experience maternal mortality than white women. Recently, the American College of Obstetricians and Gynecologists recognized the deficiencies in postpartum care and coined the term the 'fourth trimester' to mark the time following the birth of the infant through the first 3-months postpartum, and updated its recommendations to address these challenges. With impacts to health outcomes and healthcare costs, there is a need to holistically bridge the gap for low-income and/or ethnically diverse groups of women to address the physical, cultural, and knowledge barriers to accessing quality postpartum care.
To improve the rate at which underserved women are disproportionately affected by maternal mortality and morbidity, the investigators need to engage women leading into and specifically during the postpartum period to identity areas of need, and to provide tools which reduce barriers for women to get appropriate postpartum care. Technology offers innovative solutions to challenges around equal information access. Pregnant women often turn to the internet to find out more information about their health and their developing babies health. Yet, studies find that mothers are not finding sufficient resources to match their postpartum needs.
To address this gap in care, this project aims to develop a mobile tool designed to increase accessibility to information and practical approaches for addressing the complex needs of women in this 'fourth trimester'. This tool will specifically focus on underserved women who are at greatest risk of adverse postpartum outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fourth Trimester Mobile Tool | Other | Fourth Trimester Mobile Tool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fourth Trimester Mobile Tool | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Resilience at 4 Weeks | 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. | baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristine Merz | Orange Square Design, Inc. | Principal Investigator |
| Lisa Marceau, MPH | Carelon Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthCore | Watertown | Massachusetts | 02472 | United States | ||
| Orange Square Design Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Post Comparison | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Resilience at 4 Weeks | 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 4 weeks |
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AEs were collected for each participant at pre-test and post-test during the four week participation window.
We surveyed participants on health-related measures at two timepoints (pre-test and post-test) and conducted weekly review of participant scores specifically for the Edinburgh Postnatal Depression Scale (EDPS) and the State-Trait Anxiety Inventory (STAI).
A 0 for all-cause mortality indicates there were no cases of mortality during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Marceau | Orange Square Designs | 4014284197 | lisa@orangesquare.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2021 | Aug 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 25, 2021 | Aug 23, 2022 | SAP_001.pdf |
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Interviews were conducted with 24 pregnant and postpartum women. From this research and other activities, the investigators built a prototype program. Once the prototype was completed, the investigators conducted a clinical trial with 87 participants. The pre-test captured key outcome measures (resilience, stress, anxiety, depression, fear, knowledge, and variables related to COVID-19) and other descriptive variables. All participants who completed the pre-test were given access to the prototype mobile postpartum tool. Participants were asked to actively engage with the tool for 4 weeks, during which time they provided real-time user experience feedback. At the end of the 4-week period, the investigators conducted a post-test to measure change in outcomes.
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| baseline, 4 weeks |
| Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey | 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. | baseline, 4 weeks |
| Change From Baseline Parent Anxiety 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. | baseline, 4 weeks |
| Change From COVID-19 and Mental Health Impacts 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. | baseline, 4 weeks |
| Pawtucket |
| Rhode Island |
| 02860 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change From Baseline Depressive Symptoms at 4 Weeks Using the Edinburgh Postnatal Depression Scale (EPDS) | 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. | 87 participants completed baseline. 79 participants completed the post-test at 4 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 4 weeks |
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| Secondary | Change From Baseline Social Support at 4 Weeks Using the MOS Social Support Survey | 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. | 87 participants completed baseline. 79 participants completed the post-test at 4 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 4 weeks |
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| Secondary | Change From Baseline Parent Anxiety 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. | 87 participants completed baseline. 79 participants completed the post-test at 4 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 4 weeks |
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| Secondary | Change From COVID-19 and Mental Health Impacts 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. | 87 participants completed baseline. 79 participants completed the post-test at 4 weeks. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline, 4 weeks |
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| 0 |
| 87 |
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| 87 |
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| 87 |
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| Difference of Post and Pre Total Score for Edinburgh Postnatal Depression Scale |
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| Difference of Post and Pre overall summary score for MOS Social Support |
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| Difference of Post and Pre Total score for State-Trait Anxiety Inventory |
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| Difference of Post and Pre Total score for COVID-19 and Mental Health Impacts |
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