- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06689930
Gemenskapsbaserat genomförande av STAC
Gemenskapsbaserad hälsofrämjande och förebyggande modifiering Att hålla sig frisk efter (runt) förlossning med högt blodtryck under graviditeten genom postpartum
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria (Interviews and Focus Groups):
- Belong to the STAC-CAB or Lived Experience Group
- Aged 18 or older
Inclusion Criteria (CBO Staff):
- Staff of CBO participating in PDSA cycle
- Aged 18 years or older
Inclusion Criteria (PDSA-Cycles):
- Pregnant persons greater than or equal to 24 weeks gestation and prior to delivery or postpartum
- Self-Identify as African American or Black
- 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
Exclusion Criteria (PDSA-Cycles):
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: STAC-CAB Members
Staying Healthy After Childbirth - Community Advisory Board members (8-12 members) |
|
|
Inget ingripande: Lived Experience Group Members
Lived Experience Group members (8-12 members) |
|
|
Experimentell: PDSA Cycle Participants and CBO Staff
Black pregnant or postpartum persons and Community Based Organization Staff |
Conduct PDSA cycles and follow-up interviews and surveys for patients (3-5 per cycle, 10 total) and CBO staff (no less than 2) |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Qualitative Summary of Barriers to Implementation of A-STAC
Tidsram: 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. |
up to 4 weeks
|
|
Qualitative Summary of Facilitators to Implementation of A-STAC
Tidsram: 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. |
up to 4 weeks
|
|
Qualitative Summary of Adaptations to STAC
Tidsram: 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. |
up to 8 weeks
|
|
The Acceptability of Intervention Measure (AIM)
Tidsram: 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. |
up to 8 weeks
|
|
The Intervention Appropriateness Measure (IAM)
Tidsram: 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. |
up to 8 weeks
|
|
The Feasibility of Intervention Measure (FIM)
Tidsram: 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. |
up to 8 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kara Hoppe, DO, PhD, University of Wisconsin, Madison
- Huvudutredare: Andrew Garbacz, PhD, University of Wisconsin, Madison
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-1594
- U48DP006793 (U.S.S. NIH-anslag/kontrakt)
- Protocol Approved 5/14/26 (Annan identifierare: UW Madison)
Plan för individuella deltagardata (IPD)
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