A Culturally Adapted Decision Aid Intervention to Support Chinese American Dementia Caregivers in Feeding-Related Decisions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorYaolin Pei
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Dementia patients are a) receiving tube feeding, b) enrolled in hospice care, or 3) have a documented preference against a feeding tube
Trial design
Design model
Parallel
Treatments tested in this trial
Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid
Other interventionParticipants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Participation GroupNo intervention 0 interventions
Group B: Intervention/Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decision conflict
SURE test for decisional conflict (0-4)
Time frame
Baseline; One-Month Follow-Up; Three-Month Follow-Up2
Knowledge of feeding options and dementia
Questions to assess knowledge about feeding options and dementia
Time frame
Baseline; One-Month Follow-Up; Three-Month Follow-Up3
Expectations of tube feeding
Questions about understanding differing expectations regarding feeding tube use
Time frame
Baseline; One-Month Follow-Up; Three-Month Follow-UpSecondary outcomes
1
Frequency of communication with other family members and healthcare providers
Questions to understand caregiver involvement, support, and information flow
Time frame
Baseline; One-Month Follow-Up; Three-Month Follow-Up2
Preference of feeding option
Careful hand feeding, tube feeding, or unsure
Time frame
Baseline; One-Month Follow-Up; Three-Month Follow-Up3
Preparation for decision-making scale (treatment group only)
Questions to assess the effect of the intervention by preparing for feeding option decision-making
Time frame
One-Month Follow-Up; Three-Month Follow-Up4
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.
Time frame
EnrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yaolin Pei
Lead sponsor
University of Texas at Austin
Sponsor institution
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov