Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
調査の概要
詳細な説明
1 OBJECTIVES The purpose of this study is to evaluate the feasibility and acceptability of Waning Moon to inform future clinical trials. Our objectives are to 1) engage AI/AN partners to further co-develop the intervention protocols and training processes for CHWs and 2) assess the feasibility and acceptability of Waning Moon. The data gathered will inform a future multisite efficacy study of the intervention. This work is supported by preliminary data from our co-development of Waning Moon.
1.1 Overall Study Methods This R34 will support a three-year project (Figure 4) to establish new relationships with AI/AN communities while strengthening our established 3-year relationship with UICSL (Letter of Support) and feasibility testing the Waning Moon intervention. Once all approvals are in place, we will develop a Leadership Advisory Board (LAB) comprised of UICSL clinical and community AI/AN leaders or members of the Utah Indian Health Advisory Board (UIHAB, Letter of Support); to recruit additional Community Advisory Board (CAB) members. Several prior CAB members wish to continue their engagement (Letter of Support). Should Waning Moon be deemed feasible and acceptable in the presently proposed study, the research team in collaboration with the Boards will design a subsequent multisite feasibility study in alignment with the NCCIH Research Framework.2
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lisa J Associate Professor, College of Nursing, University of Utah
- 電話番号：801-585-5486
- メール：lisa.taylor-swanson@nurs.utah.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Self-identifies as American Indian or Alaska Native Female, age 35-65 Experiencing menopause-related symptoms (e.g., vasomotor symptoms) Able to attend sessions at UICSL in Salt Lake City, Utah English-speaking
Exclusion Criteria:
Currently enrolled in another menopause intervention study Do not identify as American Indian or Alaska Native Are not experiencing menopause
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：他の
- 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 |
|---|---|
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実験的：Waning Moon Intervention
Four-session integrative medical group visit program delivered by community health workers with prescribing provider involvement.
Sessions cover menopause education, complementary health approaches including acupressure, mindfulness, and herbal supplements, and facilitated community discussion.
Participants also complete a follow-up visit at 12 weeks.
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Waning Moon is a culturally tailored integrative medical group visit program developed by and for urban American Indian/Alaska Native women experiencing menopause.
The program consists of four weekly 90-minute group sessions delivered by trained community health workers, with involvement from prescribing providers.
Sessions integrate conventional and complementary menopause education, experiential practices (mindfulness, self-acupressure), and facilitated group discussion.
Topics include vasomotor symptoms, insomnia, stress, pain, inflammation, cardiovascular health, and goal setting.
Participants are referred to onsite prescribing providers for clinical evaluation and management as indicated.
他の名前：
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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 |
|---|---|---|
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Feasibility - Feasibility of Intervention Measure (FIM) scale
時間枠：Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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Participant-reported feasibility of the Waning Moon intervention as measured by the Feasibility of Intervention Measure (FIM) scale.
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Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention Appropriateness Measure (IAM)
時間枠：Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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Participant-reported acceptability of the Waning Moon intervention as measured by the Intervention Appropriateness Measure (IAM) scale.
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Baseline (Week 0), post-intervention (Week 4), and 2-month follow-up (Week 12)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intervention Fidelity
時間枠：Each Waning Moon session (Weeks 1 through 4)
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Counts and proportions of fidelity to Waning Moon session manuals as measured by a fidelity checklist completed by the study team.
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Each Waning Moon session (Weeks 1 through 4)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
- 1R34AT013448-01 (米国 NIH グラント/契約)
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
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