Waning Moon: A Whole Person Health Intervention Designed by and for Urban Menopausal American Indian/Alaska Native Women
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Lisa J Associate Professor, College of Nursing, University of Utah
- Telefonnummer: 801-585-5486
- E-mail: lisa.taylor-swanson@nurs.utah.edu
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility - Feasibility of Intervention Measure (FIM) scale
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Intervention Appropriateness Measure (IAM)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intervention Fidelity
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1R34AT013448-01 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Waning Moon
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Puerta de Hierro University HospitalAfsluttetAttention Deficit Hyperactivity DisorderSpanien
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Puerta de Hierro University HospitalInstituto de Salud Carlos III; Ministerio de Economía y Competitividad,... og andre samarbejdspartnereUkendtAttention Deficit Disorder med hyperaktivitetSpanien