En kulturelt tilpasset beslutningsstøtteintervensjon for å støtte kinesisk-amerikanske demensomsorgspersoner i beslutninger relatert til ernæring
En kulturelt tilpasset beslutningsstøtteintervensjon for å støtte kinesisk-amerikanske demensomsorgsgivere i beslutninger knyttet til ernæring
Family caregivers of people with dementia have to decide between tube feeding and hand feeding when persistent eating problems arise. This decision can be difficult for Chinese American dementia caregivers, due to the interplay of culture, potential absence of a patient's advance directive, poor understanding of dementia, and lack of knowledge on the risks and benefits of tube feeding. In this polit study, the principal investigator examines whether a culturally adapted decision aid intervention regarding feeding options named "Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid" (CMCFODA) will improve Chinese American caregivers' decision-making about feeding options in patients with moderate or advanced dementia. The proposed study advances the field by providing critical evidence to inform the development and implementation of culturally adapted decision support interventions in end-of-life dementia care.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Yaolin Pei, Ph.D.
- Telefonnummer: 8064708689
- E-post: yaolin.pei@austin.utexas.edu
Studiesteder
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Texas
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Austin, Texas, Forente stater, 78712
- Rekruttering
- School of Nursing at UT Austin
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Ta kontakt med:
- E-post: peiyaolin1983@gmail.com
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Hovedetterforsker:
- Yaolin Pei, PhD
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Ta kontakt med:
- Yaolin Pei, PhD
- Telefonnummer: 8064708689
- E-post: yaolin.pei@austin.utexas.edu
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age 21 years and older
- Self-identify as Chinese
- Providing caregiving or involvement in end-of-life care decision-making for older Chinese adults with: a) moderate or advanced dementia, b) feeding difficulties, and c) poor oral intake, eating/swallowing problems, or weight loss
Exclusion Criteria:
- Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: Participation Group
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Eksperimentell: Intervention/Treatment Group
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Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Decision conflict
Tidsramme: Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
SURE test for decisional conflict (0-4) |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Knowledge of feeding options and dementia
Tidsramme: Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions to assess knowledge about feeding options and dementia |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Expectations of tube feeding
Tidsramme: Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions about understanding differing expectations regarding feeding tube use |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of communication with other family members and healthcare providers
Tidsramme: Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions to understand caregiver involvement, support, and information flow |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Preference of feeding option
Tidsramme: Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Careful hand feeding, tube feeding, or unsure |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Preparation for decision-making scale (treatment group only)
Tidsramme: One-Month Follow-Up; Three-Month Follow-Up
|
Questions to assess the effect of the intervention by preparing for feeding option decision-making |
One-Month Follow-Up; Three-Month Follow-Up
|
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The Feasibility of the CMCFODA study as measured by recruitment rates and the proportion of participants that decline participation.
Tidsramme: Enrollment
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The feasibility of the CMCFODA study will be measured by the proportion of eligible participants who decline to participate among those who were screened into the study. |
Enrollment
|
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The Feasibility of the CMCFODA study as measured by participant retention, as indicated by the number of participants lost to follow-up.
Tidsramme: Enrollment, One-Month Follow-Up,Three-Month Follow-Up
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Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants number lost to follow-up. |
Enrollment, One-Month Follow-Up,Three-Month Follow-Up
|
|
Acceptability of the decision aid and decision coaching (only for the treatment group)
Tidsramme: One Month Follow-Up
|
We will use developed questions to measure the acceptability of this intervention |
One Month Follow-Up
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- STUDY00007171
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Data collected for the CMCFODA study will be shared only after the investigators have published findings addressing the study's specific aims. Intellectual property and data generated under this project will be managed in accordance with University of Texas at Austin and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. Following publication of the investigators' primary findings, access to the study databases and associated decision aid intervention tools will be made available for educational, research, and non-profit purposes.
IPD-delingstidsramme
These data will be shared after the investigators have published the study's specific aims. Requests to access the code for this study will be reviewed by the investigative team and granted once feasibility, acceptability, and preliminary efficacy have been evaluated and the findings have been published.
Tilgangskriterier for IPD-deling
Individuals who wish to access the data must agree to: (1) use the data solely for research purposes; (2) not attempt to identify any individual participant; (3) securely store the data using appropriate safeguards, such as password-protected servers and files; and (4) return and/or destroy the data upon completion of analyses.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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