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Post-PartumNCT05339867

Prevent Maternal Mortality Using Mobile Technology

A study testing Prevent Maternal Mortality using Mobile technology (PM3) in people with Post-Partum, run by Emory University at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Post-Partum
What is being tested?
Prevent Maternal Mortality using Mobile technology (PM3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
2 sitesUnited States
Study dates
22 Mar 2022to Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants self -identify as female
  • Participants must self-identify as African American/Black
  • Aged 18-45 years
  • Can speak or read English
  • Participants must be able to give consent.
  • Own a smart phone
Show all 9Show fewer
  • Reside in or near Albany, LaGrange, or Waynesboro (within a 40 mile radius)
  • Be in third trimester or recently had a baby (≤4 weeks postpartum)
  • Can be contacted by phone or email after hospital discharge.

Who cannot join

  • Women will be excluded if they have known unavailability to follow-up
  • An active severe mental health condition, or developmental disability precluding informed consent

Trial locations and contacts

2 sites in 1 country.

Rasheeta Chandler, PhD contact

404-727-8164

r.d.chandler@emory.edu

Rashidat Ayantunji, MPH contact

rayantu@emory.edu

United States2 sites, 2 recruiting
  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

    Natalie Hernandez, PhD, 404-752-1523, nhernandez@msm.edu

    Recruiting
  • Emory University, Nell Hodgson Woodruff School of Nursing

    Atlanta, Georgia, 30322

    Rasheeta Chandler, PhD, 404-727-8164, r.d.chandler@emory.edu

    Recruiting

Other trials in United States

About this study

Official title: Prevent Maternal Mortality Using Mobile Technology (PM3)

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.

Read the detailed description

Black women in Georgia have the highest risk for adverse maternal outcomes, with a staggering 66.6 deaths per 100,000 live births, compared to 18.1 for Hispanic women and 43.2 for white women. In rural Georgia, these statistics are more profound, with Black women experiencing 126.7 deaths per 100,000 live births compared to 78.3 deaths for White women. These disparities have existed for centuries and have also widened significantly over the last several decades.

The proposed research aims to increase the effectiveness of postpartum discharge education and improve rural Black women's compliance with postpartum care recommendations by developing and testing a culturally-informed "mhealth intervention" entitled Prevent Maternal Mortality using Mobile technology (PM3).

Conditions
Post-Partum
Being tested
Prevent Maternal Mortality using Mobile technology (PM3)
Keywords
Postpartum Black mothers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prevent Maternal Mortality using Mobile technology (PM3)Behavioural

    PM3: The app will include:

    1. integrated self-management and tailored health messaging feature
    2. support center based on social support gaps which will also provide a centralized place for identifying healthcare providers and facilities
    3. multimedia resource kit comprised of videos, current events, news feeds, podcasts, and support groups related to women's postpartum health and community resources
    4. a feature that will update women on maternal and reproductive health policies that impact women.
Study groups in NCT05339867
Study groupRoleWhat they receive
Mothers following Standard of CareNo interventionParticipants randomized to this group will receive standard of Care for Postpartum. The standard of care control condition will be what women would typically get at hospital discharge (typically an Electronic Medical Record (EMR) generated document; a non-standardized, generalized brief review of how to care for self and the baby).
Mother Using PM3 InterventionExperimentalParticipants in this group will be using the PM3 intervention. PM3 is a maternal mortality prevention and optimal reproductive health promotion mobile app created based on formative work with Black women to ultimately increase postpartum comorbidity self-management, promote timely provider notification of postpartum-related complications, and ensure access to social support and community resources.
Receives: Behavioral: Prevent Maternal Mortality using Mobile technology (PM3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of completion of postpartum healthcare visit ( Healthcare Resource utilization)

    Around 50% of the women receive a postpartum visit within that time. The study aims to increase postpartum visit attendance by 25% for a goal of 75%. The completion of a visit and other clinical outcomes will be confirmed by a medical chart review. This will be measured as number of participants completing the post partum healthcare visit.

    Measured: At weeks 4 to 6 postpartum

Secondary outcomes (18)
  1. Changes in Current Life Situation

    All participants will complete a brief online socio-demographic survey containing closed-ended sociodemographic questions (e.g. marital status, educational attainment, employment status, health insurance status, total household income).

    Measured: Baseline, month 3, month 6 and month 12

  2. Changes in Women Sexual Health History

    All participants will complete a brief online socio-demographic survey containing closed-ended sociodemographic questions (e.g. marital status, educational attainment, employment status, health insurance status, total household income).

    Measured: Baseline, month 3, month 6 and month 12

  3. Changes in Blood pressure

    BP self-monitoring instructions will be provided when patients are enrolled, and patients will be expected to demonstrate understanding of how to take their own blood pressure and enter results into PM3. Using color-coded instructions, BP self-monitoring parameters will be used to create algorithms within the app. For instance, when patients input their BP, they will be prompted to retake the BP. If the second reading is outside the expected range, this will automatically trigger a request for a third reading (taken after 5 minutes). Persistent high or low readings will automatically trigger a message asking the participant to contact their obstetric provider or seek care at an emergency department. The app will provide notifications to remind patients to take their BP. Participants will be asked to take 1 BP measurement in the morning and 1 in the evening. Additionally, they will be asked to enter 1 weight measurement weekly.

    Measured: Baseline, month 3, month 6 and month 12

  4. Changes in Health related quality of life questionnaires (HRQoL)

    Health-related quality of life (HRQOL) is used to examine the impact of health status on quality of life. HRQOL is often measured by four core questions that asked about general health status and number of unhealthy days in the Behavioral Risk Factor Surveillance System (BRFSS) Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. The responses to questions 2 and 3 are combined to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days.

    Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculate by subtracting the number of unhealthy days from 30 days.

    Measured: Baseline, month 3, month 6 and month 12

  5. Changes in Hair cortisol levels

    Cortisol is a steroid hormone synthesized and secreted by the adrenal cortex and plays many important roles in regulating physiology including regulating the responses to acute and chronic stress. Hair is considered a reliable and stable measure of cortisol production and chronic stress. All study participants in the control and intervention arms will provide hair samples at baseline and at 3 months postpartum.

    During the study visit a strand of hair is cut, using fine scissors, as close to the participant's scalp as possible from a posterior vertex position. The hair is wrapped in aluminum foil to maintain the sample's integrity and avoid exposure to elements that might contaminate it. Hair samples are stored at room temperature in our lab space. On average, hair grows approximately one cm per month, allowing for approximately three months of aggregated cortisol data to be analyzed from each sample as a 3 cm hair segment reflects cumulative cortisol secretion over the past 3 months.

    Measured: Baseline and 3 months

  6. Edinburg Postpartum Depression Scale

    Early Depression Screening: 10-question Edinburg Postnatal Depression Scale (EPDS). This is a way of identifying patients at risk for perinatal depression. The EPDS is easy to administer and has proven to be an effective screening tool. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity. The EPDS score should not override clinical judgment. A careful clinical assessment should be carried out to confirm the diagnosis. The scale indicates how the mother has felt during the previous week. In doubtful cases it may be useful to repeat the tool after 2 weeks. The scale will not detect mothers with anxiety neuroses, phobias or personality disorders.

    QUESTIONS 1, 2, \& 4 :Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3.

    QUESTIONS 3, 5-10: Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater

    Measured: Baseline, month 3, month 6 and month 12

  7. Changes in Promis-GSF

    Patient Reported Outcomes Measurement Information System (PROMIS) Global Short Form (GSF) instrument consists of ten global health items that represent five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Four items are used to assess global physical health. Three of these are administered using five-category response scales, and one item (rating of pain on average) uses a response scale of 0-10 that is recoded to five categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5).

    Measured: Baseline, month 3, month 6 and month 12

  8. Discrimination & Stigma Scale

    The Discrimination and Stigma Scale (DISC) is measure of discrimination experienced based on having a mental health problem. The DISC has a 4-point Likert scale (not at all; a little; moderately; a lot) and assesses experiences of discrimination across 21 life domains including family, friends, dating or intimate relationships, housing and employment.

    Measured: Baseline, month 3, month 6 and month 12

  9. System Usability Scale

    The System Usability Scale (SUS) provides a quick, reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.

    The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking.

    A SUS score above a 68 would be considered above average and anything below 68 is below average, however the best way to interpret your results involves "normalizing" the scores to produce a percentile ranking.

    Measured: Baseline, month 3, month 6 and month 12

  10. Race-related stress (Index of Race-Related Stress-Brief)(IRRS-B)

    The 22-item IRRS-B aims to measure psychological stress related to experiences of racism for Black Americans in 3 subscales. The Cultural Racism subscale assesses the experience of racism when one's culture is vilified. The Institutional Racism subscale measures racism that is deeply entrenched in a particular institution's structure, policies, and processes. The Individual Racism subscale measures interpersonal racism. Participants will be asked to indicate their experience with and reaction to the events depicted in each item using a 5-point Likert-type scale (0 = this never happened to me; 1 = this event happened, but did not bother me; 2 = this event happened and I was slightly upset; 3 = this event happened and I was upset; 4 = this event happened and I was extremely upset). Items from each of the three subscales are summed to yield subscale scores, and higher scores indicate respondents endorsing a greater degree of stress as a result of their encounters with racism.

    Measured: Baseline, month 3, month 6 and month 12

  11. Changes in Sleep (Karolinska Sleep Questionnaire - KSS)

    This scale measures the subjective level of sleepiness at a particular time during the day. On this scale subjects indicate which level best reflects the psycho-physical sate experienced in the last 10 min. The KSS is a measure of situational sleepiness. It is sensitive to fluctuations. This is a 9-point scale (1 = extremely alert, 3= alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep). Scores on the KSS increase with longer periods of wakefulness and it strongly correlate with the time of the day.

    Measured: Baseline, month 3, month 6 and month 12

  12. Medical Mistrust Index (MMI)

    The MMI includes 16 items on a 4-response Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree) (eg, "The US health care system has done harmful experiments on patients without their knowledge," "I trust that health care organizations keep up with the latest medical information"). Responses will be coded so that higher scores indicated higher mistrust.

    Measured: Baseline, month 3, month 6 and month 12

  13. Stressful Events Questionnaire

    The Stressful Life Events Screening Questionnaire (SLESQ) is a 13-item self-report measure for non-treatment seeking samples that assesses lifetime exposure to traumatic events. Eleven specific and two general categories of events, such as a life-threatening accident, physical and sexual abuse, witness to another person being killed or assaulted, are examined. For each event, respondents are asked to indicate whether the event occurred ("yes" or "no"), their age at time of the event, as well as other specific items related to the event, such as the frequency, duration, whether anyone died, or was hospitalization, etc.

    Measured: Baseline, month 3, month 6 and month 12

  14. Adverse Childhood Experiences (ACEs) questionnaire

    If the ACE score is 1-3 without ACE-Associated Health Conditions, the patient is at "intermediate risk" for toxic stress. If the ACE score is 1-3 and the patient has at least one ACE-associated condition, or if the ACE score is 4 or higher, the patient is at "high risk" for toxic stress.

    Measured: Baseline, month 3, month 6 and month 12

  15. General Perceived Self-Efficacy Scale

    The General Perceived Self-Efficacy Scale (GSES) is a ten-item scale that assessed the strength of an individual's belief in his/her own ability to respond to novel or difficult situations and to deal with any associated obstacles or setbacks. It is a self administered scale that normally takes 2-3 minutes to complete. For each item there is a four choice response from "not at all true" which scores 1, to "Exactly true" which scores 4. The scores of each item are summed to give a total score. The score on this scale reflects the strength of an individual's generalized efficacy belief. Thus the higher the score, the greater in the individual's generalized self-efficacy.

    Measured: Baseline, month 3, month 6 and month 12

  16. Social Support- The Medical Outcomes Study

    This brief, self-administered Social Support Survey instrument was developed for patients in the Medical Outcomes Study (MOS).The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support.

    To obtain a score for each subscale, calculate the average of the scores for each item in the subscale.

    To obtain an overall support index, calculate the average of (1) the scores for all 18 items included in the four subscales, and (2) the score for the one additional item (see last item in the survey).

    To compare to published means in the article referenced below, scale scores can be transformed to a 0-100 scale using the following formula:100 x ((observed score - minimum possible score) / (maximum possible score - minimum possible score))

    Measured: Baseline, month 3, month 6 and month 12

  17. The Neighborhood Questionnaire

    The Neighborhood Questionnaire is a 16-item measure that assesses a parent's satisfaction with the family's neighborhood. The questionnaire explores sociability in the neighborhood, the neighborhood's stability, the quality of public services, neighborhood safety, the incidence of violent crime, drug traffic in the neighborhood, the parent's involvement with neighbors, and the parent's participation in neighborhood organizations. One item has nine response choices. Items ask about satisfaction level, quality, duration, quantity, level of involvement, and frequency. Three items are yes/no questions.

    This measure has three subscales: the Neighborhood Safety Subscale (items 1, 6, 10, 11, and 12), the Neighborhood Social Involvement Subscale (items 3, 4, 5, and 13), and the Public Services Subscale (items 8 and 9).

    Measured: Baseline, month 3, month 6 and month 12

  18. Appraisal of self-care agency Scale-Revised (ASAS-R)

    The Appraisal of Self-care Agency Scale (ASA-R) is one of the main instrument to assess self-care capacity. The ASA is a 24-item scale and each item is responded to on a five-point Likert type scale ranging from 1 (totally disagree) to 5 (totally agree) and with a total score that ranges from 24 to 120. The higher the score, the better the self-care agency.

    Measured: Baseline, month 3, month 6 and month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start22 Mar 2022
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05339867
Sponsor's protocol ID
STUDY00003016
Status last verified
Apr 2022
First submitted
4 Apr 2022
Last updated
21 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prevent Maternal Mortality using Mobile technology (PM3) in people with Post-Partum, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rasheeta Chandler, PhD (404-727-8164, r.d.chandler@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of completion of postpartum healthcare visit ( Healthcare Resource utilization) (time frame: At weeks 4 to 6 postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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