コミュニティベースの STAC の導入
妊娠中から産後まで高血圧を伴う出産後(前後)の健康維持を改善する地域ベースの健康増進と予防
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Wisconsin
-
Madison、Wisconsin、アメリカ、53792
- University of Wisconsin
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし:STAC-CAB Members
Staying Healthy After Childbirth - Community Advisory Board members (8-12 members) |
|
|
介入なし:Lived Experience Group Members
Lived Experience Group members (8-12 members) |
|
|
実験的: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) |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative Summary of Barriers to Implementation of A-STAC
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Kara Hoppe, DO, PhD、University of Wisconsin, Madison
- 主任研究者:Andrew Garbacz, PhD、University of Wisconsin, Madison
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2024-1594
- U48DP006793 (米国 NIH グラント/契約)
- Protocol Approved 5/14/26 (その他の識別子:UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。