Eine kulturell angepasste Entscheidungshilfe-Intervention zur Unterstützung chinesisch-amerikanischer Demenzpflegekräfte bei ernährungsbezogenen Entscheidungen
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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Yaolin Pei, Ph.D.
- Telefonnummer: 8064708689
- E-Mail: yaolin.pei@austin.utexas.edu
Studienorte
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Texas
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Austin, Texas, Vereinigte Staaten, 78712
- Rekrutierung
- School of Nursing at UT Austin
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Kontakt:
- E-Mail: peiyaolin1983@gmail.com
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Hauptermittler:
- Yaolin Pei, PhD
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Kontakt:
- Yaolin Pei, PhD
- Telefonnummer: 8064708689
- E-Mail: yaolin.pei@austin.utexas.edu
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Participation Group
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|
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Experimental: Intervention/Treatment Group
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Sonstiges: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid
Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Decision conflict
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Frequency of communication with other family members and healthcare providers
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
|
|
The Feasibility of the CMCFODA study as measured by recruitment rates and the proportion of participants that decline participation.
Zeitfenster: Enrollment
|
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.
Zeitfenster: Enrollment, One-Month Follow-Up,Three-Month Follow-Up
|
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)
Zeitfenster: One Month Follow-Up
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We will use developed questions to measure the acceptability of this intervention |
One Month Follow-Up
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- STUDY00007171
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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.
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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