Dementia CaregiversNCT07370311
A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions
A study testing Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid in people with Dementia Caregivers and End of Life Decision Making, run by Yaolin Pei at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Dementia Caregivers, End of Life Decision Making, Advanced Dementia
- What is being tested?
- Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
School of Nursing at UT Austin
Austin, Texas, 78712
Yaolin Pei, PhD, 8064708689, yaolin.pei@austin.utexas.edu
peiyaolin1983@gmail.com
About this study
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.
- Being tested
- Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid
- Keywords
- Chinese Americans, feeding options, decision aid, decision coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese version of Making Choices Feeding Options for Patients with Dementia Decision AidOther
Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision conflict
SURE test for decisional conflict (0-4)
Measured: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Knowledge of feeding options and dementia
Questions to assess knowledge about feeding options and dementia
Measured: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Expectations of tube feeding
Questions about understanding differing expectations regarding feeding tube use
Measured: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Secondary outcomes (6)
Frequency of communication with other family members and healthcare providers
Questions to understand caregiver involvement, support, and information flow
Measured: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Preference of feeding option
Careful hand feeding, tube feeding, or unsure
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: One Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start24 Mar 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yaolin Pei
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Yaolin Pei, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370311
- Sponsor's protocol ID
- STUDY00007171
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions
- ClinicalTrials.gov ID
- NCT07370311
- Acronym / sponsor ID
- STUDY00007171
- Keywords
- Chinese Americans, feeding options, decision aid, decision coaching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yaolin PeiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid1. Receive both the electronic and paper version of CMCFODA 2. Receive an individualized decision coaching within two weeks |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese version of Making Choices Feeding Options for Patients with Dementia Decision AidParticipants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching. | Other | Intervention/Treatment Group |
Primary outcome
Decision conflict
Time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up
SURE test for decisional conflict (0-4)
Knowledge of feeding options and dementia
Time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Questions to assess knowledge about feeding options and dementia
Expectations of tube feeding
Time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Questions about understanding differing expectations regarding feeding tube use
6 secondary outcomes
Frequency of communication with other family members and healthcare providers
Time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Preference of feeding option
Time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up
Preparation for decision-making scale (treatment group only)
Time frame: 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.
Time frame: Enrollment
The Feasibility of the CMCFODA study as measured by participant retention, as indicated by the number of participants lost to follow-up.
Time frame: Enrollment, One-Month Follow-Up,Three-Month Follow-Up
Acceptability of the decision aid and decision coaching (only for the treatment group)
Time frame: One Month Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid in people with Dementia Caregivers and End of Life Decision Making, run by Yaolin Pei at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaolin Pei, Ph.D. (8064708689, yaolin.pei@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision conflict (time frame: Baseline; One-Month Follow-Up; Three-Month Follow-Up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.