- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899737
Monitoring and Outreach for Maternal Safety Postpartum (MOMSPostpartum)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the MOMS Postpartum course and explore the following research question: To what extent does exposure to the MOMS Postpartum course increase CHWs' knowledge, skills, attitudes/beliefs, self-efficacy, and intentions to provide support to postpartum mothers?
MOMS Postpartum course is set in context of imperative need of assisting postpartum mothers in the U.S. and working with CHWs after pregnancy to have better maternal outcomes, particularly among high-risk mothers. Researchers worked with subject matter experts, CHWs, and the intended audience to ensure the MOMS Postpartum course reflects the specific needs of postpartum mothers; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with high-risk postpartum mothers. MOMS Postpartum course will provide an effective, low-cost, evidence-based, professional development curriculum to train CHWs to provide support to postpartum mothers and fill a gap in care.
The Principal Investigator (PI), with input from the subject matter experts and CHWs, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include CHW Association of Rochester, Center for Health Innovation, and other CHW organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, CHWs will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to MOMS Postpartum course and will complete an online posttest survey after completing the online modules. The control group participants will not be exposed to the MOMS Postpartum course and will complete a posttest one week after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of MOMS Postpartum course exposure on changes in CHWs' knowledge, skills, attitudes/beliefs, perceived self-efficacy, and intentions to conduct outreach to postpartum mothers.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to MOMS Postpartum course and increased knowledge among the intervention group in comparison to the control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30309
- KDH Research & Communication
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be at least 18 years old.
- Must self-identify as a community health worker (CHW).
- Must live in the United States.
- Must have six months of field experience. KDHRC defines "field experience" as conducting outreach activities in their community, for example, working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events.
- Must be an active CHW. KDHRC defines "active" as conducting outreach activities, such as working with clients in a clinic, conducting home visits, or educating clients at health fairs or community events, in the last six months.
- Must have Internet access either at home or at work to access the lessons and/or online surveys.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period.
Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group.
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Experimental: Treatment: MOMS Postpartum course
Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program.
They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy.
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Online professional development training for CHWs on outreach and support for high-risk postpartum mothers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge Pretest Score
Time Frame: Pretest (Baseline)
|
Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons.
The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions.
Higher scores indicate greater knowledge.
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Pretest (Baseline)
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Knowledge Posttest Score
Time Frame: Posttest (1 week after baseline)
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Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons.
The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions.
Higher scores indicate greater knowledge.
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Posttest (1 week after baseline)
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|
Skills Pretest Score
Time Frame: Pretest (Baseline)
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Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Pretest (Baseline)
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Skills Posttest Score
Time Frame: Posttest (1 week after baseline)
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Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Posttest (1 week after baseline)
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Self-efficacy Pretest Score
Time Frame: Pretest (Baseline)
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Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers
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Pretest (Baseline)
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Self-efficacy Posttest Score
Time Frame: Posttest (1 week after baseline)
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Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers
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Posttest (1 week after baseline)
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Attitudes Pretest Score
Time Frame: Pretest (Baseline)
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Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Pretest (Baseline)
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Attitudes Posttest Score
Time Frame: Posttest (1 week after baseline)
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Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Posttest (1 week after baseline)
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Intentions Pretest Score
Time Frame: Pretest (Baseline)
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Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Pretest (Baseline)
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Intentions Posttest Score
Time Frame: Posttest (1 week after baseline)
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Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers
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Posttest (1 week after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Satisfaction at Posttest
Time Frame: Posttest (1 weeks after baseline)
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Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, to measure CHWs' satisfaction with the course, interactive experiences, and offline resources and measure the extent to which CHWs would recommend the course
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Posttest (1 weeks after baseline)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Knowledge Scores From Pretest to Posttest
Time Frame: From pretest to posttest (1 week)
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At both pretest and posttest, we asked all participants the same multiple choice knowledge questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons, which we will average to create a composite knowledge score for each participant ranging from 0 to 100.
A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct.
We will average these composite scores across all participants for both groups to create mean scores.
We then subtracted pretest scores from posttest scores and will average these changes for all participants.
Positive scores mean a gain in knowledge and a higher scores mean higher gains from baseline to posttest.
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From pretest to posttest (1 week)
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Change in Skills Scores From Pretest to Posttest
Time Frame: From pretest to posttest (1 week)
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Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers.
We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups.
We will then subtract pretest scores from posttest scores and averaged these changes for all participants.
Positive scores mean a gain in skills and higher scores mean higher gains from baseline to posttest.
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From pretest to posttest (1 week)
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Change in Self-Efficacy Scores From Pretest to Posttest
Time Frame: From pretest to posttest (1 week)
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Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum women.
We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups.
We will then subtract pretest scores from posttest scores and average these changes for all participants.
Positive scores mean a gain in self-efficacy and higher scores mean higher gains from baseline to posttest.
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From pretest to posttest (1 week)
|
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Change in Attitudes Scores From Pretest to Posttest
Time Frame: From pretest to posttest (1 week)
|
Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers.
We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups.
We will then subtract pretest scores from posttest scores and averaged these changes for all participants.
Positive scores mean a gain in attitudes and higher scores mean higher gains from baseline to posttest.
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From pretest to posttest (1 week)
|
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Change in Intention Scores From Pretest to Posttest
Time Frame: From pretest to posttest (1 week)
|
Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers.
We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups.
We then subtracted pretest scores from posttest scores and averaged these changes for all participants.
Positive scores mean a gain in intentions and higher scores mean higher gains from baseline to posttest.
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From pretest to posttest (1 week)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dexter L Cooper, MPH, KDH Research & Communication
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-02-03
- 1R43MD019206-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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