A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions

NCT07370311 | Recruiting

• 1 other identifier: STUDY00007171
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia Caregivers; End of Life Decision Making; Advanced Dementia

Keywords

Chinese Americans; feeding options; decision aid; decision coaching

Outcome Measures

Primary Outcomes (3)

• Decision conflict

  SURE test for decisional conflict (0-4)

  Baseline; One-Month Follow-Up; Three-Month Follow-Up

• Knowledge of feeding options and dementia

  Questions to assess knowledge about feeding options and dementia

  Baseline; One-Month Follow-Up; Three-Month Follow-Up

• Expectations of tube feeding

  Questions about understanding differing expectations regarding feeding tube use

  Baseline; One-Month Follow-Up; Three-Month Follow-Up

Secondary Outcomes (6)

• Frequency of communication with other family members and healthcare providers

  Baseline; One-Month Follow-Up; Three-Month Follow-Up

• Preference of feeding option

  Baseline; One-Month Follow-Up; Three-Month Follow-Up

• Preparation for decision-making scale (treatment group only)

  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.

  Enrollment

• The Feasibility of the CMCFODA study as measured by participant retention, as indicated by the number of participants lost to follow-up.

  Enrollment, One-Month Follow-Up,Three-Month Follow-Up

Study Arms (2)

Participation Group

NO INTERVENTION

1. Receive usual care (including information from healthcare providers) 2. Receive electrical version of decision aid after all of the data collection

Intervention/Treatment Group

EXPERIMENTAL

1. Receive both the electronic and paper version of CMCFODA 2. Receive an individualized decision coaching within two weeks

Other: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid

Interventions

Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid OTHER

Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching.

Intervention/Treatment Group

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube

Sponsors & Collaborators

• Yaolin Pei: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

School of Nursing at UT Austin

Austin, Texas, 78712, United States

RECRUITING

Central Study Contacts

Yaolin Pei, Ph.D.

CONTACT

8064708689; yaolin.pei@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 27, 2026
• Study Start: March 24, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)