Blood PressureNCT06689930
Community-based Implementation of Adapted STAC
A study testing PDSA Cycles in people with Blood Pressure and Hypertension, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension, Pregnancy Related
- What is being tested?
- PDSA Cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 28 Jul 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Belong to the STAC-CAB or Lived Experience Group
- Aged 18 or older
- Staff of CBO participating in PDSA cycle
- Aged 18 years or older
- Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum
- Self-Identify as African American or Black
Show all 11Show fewer
- Aged 18 years or older
- Capable of providing informed consent in English
- Can follow M•care System use instructions in English
- Have ownership of a functioning and reliable smartphone to upload and use the M•other App
- Interested in preventing or managing blood pressure during pregnancy
Who cannot join
- Persistent second or third trimester bleeding at time of enrollment
- Premature rupture of membranes in the current pregnancy at time of enrollment
- Known unrepaired maternal congenital heart disease requiring surgical correction
- Maternal heart failure
- Chronic kidney disease specifically requiring dialysis
- On greater than two antihypertensive medications at time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
Read the detailed description
Hypertensive disorders of pregnancy (HDP) are windows into chronic disease risk. The immediate postpartum (PP) period (6 weeks) is the highest risk and most important period for prevention of serious adverse outcomes with long term consequences. This project focuses on a multicomponent evidence-based intervention, Staying Healthy After Childbirth (STAC) that has been tested in a Midwest academic hospital. The intervention has been shown to be effective at addressing factors associated with health promotion priorities in populations with high levels of health disparities and inequities by increasing access to hypertension (HTN) care in the critical PP window by providing patients a home blood pressure monitor and access to a dedicated healthcare team that provides remote BP surveillance and antihypertensive medication titration. To optimize STAC to prevent and reduce racial disparities in immediate PP morbidity and mortality, deeper engagement with community stakeholders is critical.
This is a qualitative investigation designed as pre-implementation of the Adapted Staying Healthy After Childbirth (A-STAC) intervention.
STAC-Community Advisory Board (CAB) members and Lived Experience Group members will provide qualitative data through semi-structured interviews regarding implementation factors of STAC, including priorities for adaptation, barriers and facilitators to implementation, and usability. Rapid qualitative analysis will be used to glean themes from the qualitative data. A second round of semi-structured focus groups using the nominal decision-making process will be conducted to address the revisions to implementation strategies and determine priorities for A-STAC. Next, abbreviated study cycles to test implementation (Plan-Do-Study-Act or PDSA cycles) will take place, with Community Based Organization (CBO) partners and participating Black pregnant persons. After each PDSA cycle, interviews and surveys with patients and staff will be conducted. Rapid qualitative analysis will again be used to gain information about the usability of A-STAC from the focus group; this information will then be used to refine the A-STAC intervention. This process will be repeated for a second PDSA cycle (up to three PDSA cycles total), after which the A-STAC intervention will be finalized for implementation (registered to a separate ClinicalTrials.gov record).
Step 1: Conduct interviews with STAC-CAB members (8-12 members) and Lived Experience Group members (8-12 members) to evaluate implementation factors and priorities for adaptation of STAC.
Use rapid qualitative analysis process to glean implementation strategies.
Step 2: Conduct small focus groups (3-4 participants per group) with STAC-CAB members (8-12 members) and Lived Experience Group members separately using nominal group decision decision making process.
Address revisions to implementation strategies and priorities for A-STAC.
Step 3: Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 participants per cycle, 10 total) and CBO staff (at least 2 staff).
Step 4: Incorporate usability data from cycle 1 to refine A-STAC.
Repeat steps 3-4 for additional PDSA cycles (up to 3).
Step 5: Finalize A-STAC Intervention.
- Conditions
- Blood Pressure, Hypertension, Pregnancy Related, Health Equity
- Being tested
- PDSA Cycles
- Keywords
- Prenatal, Post Partum, Hypertensive Disorders of Pregnancy, Remote Patient Monitoring, Blood Pressure, Community-Based Participation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDSA CyclesOther
Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2)
| Study group | Role | What they receive |
|---|---|---|
| STAC-CAB Members | No intervention | Staying Healthy After Childbirth - Community Advisory Board members (8-12 members) |
| Lived Experience Group Members | No intervention | Lived Experience Group members (8-12 members) |
| PDSA Cycle Participants and CBO Staff | Experimental | Black pregnant or postpartum persons and Community Based Organization Staff Receives: Other: PDSA Cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Summary of Barriers to Implementation of A-STAC
Barriers to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding barriers will be coded for themes summarized by participant count.
Measured: up to 4 weeks
Qualitative Summary of Facilitators to Implementation of A-STAC
Facilitators to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding facilitators will be coded for themes summarized by participant count.
Measured: up to 4 weeks
Qualitative Summary of Adaptations to STAC
Adaptations to STAC will be analyzed from patient participant interviews and CBO staff participants post-PDSA cycles. Interviews will be coded for themes summarized by count.
Measured: up to 8 weeks
The Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
Measured: up to 8 weeks
The Intervention Appropriateness Measure (IAM)
The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
Measured: up to 8 weeks
The Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start22 May 2025
- Primary completion28 Jul 2026
- Study completion28 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is primarily a qualitative study designed to identify implementation strategies for the Adapted Staying Healthy After Childbirth (A-STAC). This pre-implementation phase includes 10 pilot participants and at least 2 CBO staff.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kara Hoppe, DO, PhD, Principal investigator, University of Wisconsin, MadisonAndrew Garbacz, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689930
- Sponsor's protocol ID
- 2024-1594
- Other IDs
- Protocol Approved 5/14/26, U48DP006793
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of a Community-driven Approach to Improve the Health of Women, Infants, and Families: Pre-implementation Phase to Adapt Staying Healthy After Childbirth (STAC)
- ClinicalTrials.gov ID
- NCT06689930
- Acronym / sponsor ID
- 2024-1594
- Conditions
- Blood Pressure, Hypertension, Pregnancy Related, Health Equity
- Keywords
- Prenatal, Post Partum, Hypertensive Disorders of Pregnancy, Remote Patient Monitoring, Blood Pressure, Community-Based Participation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 22 May 2025 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 28 Jul 2026 (actual)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
Detailed description
Hypertensive disorders of pregnancy (HDP) are windows into chronic disease risk. The immediate postpartum (PP) period (6 weeks) is the highest risk and most important period for prevention of serious adverse outcomes with long term consequences. This project focuses on a multicomponent evidence-based intervention, Staying Healthy After Childbirth (STAC) that has been tested in a Midwest academic hospital. The intervention has been shown to be effective at addressing factors associated with health promotion priorities in populations with high levels of health disparities and inequities by increasing access to hypertension (HTN) care in the critical PP window by providing patients a home blood pressure monitor and access to a dedicated healthcare team that provides remote BP surveillance and antihypertensive medication titration. To optimize STAC to prevent and reduce racial disparities in immediate PP morbidity and mortality, deeper engagement with community stakeholders is critical.
This is a qualitative investigation designed as pre-implementation of the Adapted Staying Healthy After Childbirth (A-STAC) intervention.
STAC-Community Advisory Board (CAB) members and Lived Experience Group members will provide qualitative data through semi-structured interviews regarding implementation factors of STAC, including priorities for adaptation, barriers and facilitators to implementation, and usability. Rapid qualitative analysis will be used to glean themes from the qualitative data. A second round of semi-structured focus groups using the nominal decision-making process will be conducted to address the revisions to implementation strategies and determine priorities for A-STAC. Next, abbreviated study cycles to test implementation (Plan-Do-Study-Act or PDSA cycles) will take place, with Community Based Organization (CBO) partners and participating Black pregnant persons. After each PDSA cycle, interviews and surveys with patients and staff will be conducted. Rapid qualitative analysis will again be used to gain information about the usability of A-STAC from the focus group; this information will then be used to refine the A-STAC intervention. This process will be repeated for a second PDSA cycle (up to three PDSA cycles total), after which the A-STAC intervention will be finalized for implementation (registered to a separate ClinicalTrials.gov record).
Step 1: Conduct interviews with STAC-CAB members (8-12 members) and Lived Experience Group members (8-12 members) to evaluate implementation factors and priorities for adaptation of STAC.
Use rapid qualitative analysis process to glean implementation strategies.
Step 2: Conduct small focus groups (3-4 participants per group) with STAC-CAB members (8-12 members) and Lived Experience Group members separately using nominal group decision decision making process.
Address revisions to implementation strategies and priorities for A-STAC.
Step 3: Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 participants per cycle, 10 total) and CBO staff (at least 2 staff).
Step 4: Incorporate usability data from cycle 1 to refine A-STAC.
Repeat steps 3-4 for additional PDSA cycles (up to 3).
Step 5: Finalize A-STAC Intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is primarily a qualitative study designed to identify implementation strategies for the Adapted Staying Healthy After Childbirth (A-STAC). This pre-implementation phase includes 10 pilot participants and at least 2 CBO staff.
| Arm | Type | Receives |
|---|---|---|
| STAC-CAB Members | No intervention | –Staying Healthy After Childbirth - Community Advisory Board members (8-12 members) |
| Lived Experience Group Members | No intervention | –Lived Experience Group members (8-12 members) |
| PDSA Cycle Participants and CBO Staff | Experimental | Other: PDSA CyclesBlack pregnant or postpartum persons and Community Based Organization Staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Belong to the STAC-CAB or Lived Experience Group
- Aged 18 or older
- Staff of CBO participating in PDSA cycle
- Aged 18 years or older
- Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum
Key exclusion criteria (6 listed)
- Persistent second or third trimester bleeding at time of enrollment
- Premature rupture of membranes in the current pregnancy at time of enrollment
- Known unrepaired maternal congenital heart disease requiring surgical correction
- Maternal heart failure
- Chronic kidney disease specifically requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDSA CyclesConduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2) | Other | PDSA Cycle Participants and CBO Staff |
Primary outcome
Qualitative Summary of Barriers to Implementation of A-STAC
Time frame: up to 4 weeks
Barriers to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding barriers will be coded for themes summarized by participant count.
Qualitative Summary of Facilitators to Implementation of A-STAC
Time frame: up to 4 weeks
Facilitators to implementation of A-STAC in CBOs will be investigated via qualitative analysis of interviews and focus groups with STAC-CAB members. All feedback regarding facilitators will be coded for themes summarized by participant count.
Qualitative Summary of Adaptations to STAC
Time frame: up to 8 weeks
Adaptations to STAC will be analyzed from patient participant interviews and CBO staff participants post-PDSA cycles. Interviews will be coded for themes summarized by count.
The Acceptability of Intervention Measure (AIM)
Time frame: up to 8 weeks
The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
The Intervention Appropriateness Measure (IAM)
Time frame: up to 8 weeks
The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
The Feasibility of Intervention Measure (FIM)
Time frame: up to 8 weeks
The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale from 1 = Completely Disagree to 5 = Completely Agree. Higher scores indicate higher acceptability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- STAC Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kara Hoppe, DO, PhD principal investigator
University of Wisconsin, Madison
Andrew Garbacz, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDSA Cycles in people with Blood Pressure and Hypertension, run by University of Wisconsin, Madison at 1 site 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 11 inclusion and 6 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: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Summary of Barriers to Implementation of A-STAC (time frame: up to 4 weeks). The study lists 6 primary outcomes in all. 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 23 Sep 2026.