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

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.

Study Overview

• Status: Recruiting
• Conditions: End of Life Decision Making; Dementia Caregivers; Advanced Dementia
• Intervention / Treatment: Other: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yaolin Pei, Ph.D.; Phone Number: 8064708689; Email: yaolin.pei@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • School of Nursing at UT Austin
      • Contact: Email: peiyaolin1983@gmail.com
      • Principal Investigator: Yaolin Pei, PhD
      • Contact: Yaolin Pei, PhD; Phone Number: 8064708689; Email: yaolin.pei@austin.utexas.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Participation Group; Receive usual care (including information from healthcare providers); Receive electrical version of decision aid after all of the data collection
Experimental: Intervention/Treatment Group; Receive both the electronic and paper version of CMCFODA; Receive an individualized decision coaching within two weeks	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of communication with other family members and healthcare providers	Questions to understand caregiver involvement, support, and information flow	Baseline; One-Month Follow-Up; Three-Month Follow-Up
Preference of feeding option	Careful hand feeding, tube feeding, or unsure	Baseline; One-Month Follow-Up; Three-Month Follow-Up
Preparation for decision-making scale (treatment group only)	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.	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
The Feasibility of the CMCFODA study as measured by participant retention, as indicated by the number of participants lost to 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)	We will use developed questions to measure the acceptability of this intervention	One Month Follow-Up

Collaborators and Investigators

• Sponsor: Yaolin Pei
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: decision aid; Chinese Americans; decision coaching; feeding options
• Other Study ID Numbers: STUDY00007171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No