중국계 미국인 치매 돌봄 제공자들의 식이 관련 결정을 지원하기 위한 문화적으로 적응된 의사 결정 도구 개입
중국계 미국인 치매 간병인의 식사 관련 결정을 지원하는 문화적으로 적응된 의사 결정 보조 중재
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yaolin Pei, Ph.D.
- 전화번호: 8064708689
- 이메일: yaolin.pei@austin.utexas.edu
연구 장소
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Texas
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Austin, Texas, 미국, 78712
- 모병
- School of Nursing at UT Austin
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연락하다:
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수석 연구원:
- Yaolin Pei, PhD
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연락하다:
- Yaolin Pei, PhD
- 전화번호: 8064708689
- 이메일: yaolin.pei@austin.utexas.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Participation Group
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실험적: Intervention/Treatment Group
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Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Decision conflict
기간: Baseline; One-Month Follow-Up; Three-Month Follow-Up
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SURE test for decisional conflict (0-4) |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Knowledge of feeding options and dementia
기간: Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Questions to assess knowledge about feeding options and dementia |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Expectations of tube feeding
기간: Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Questions about understanding differing expectations regarding feeding tube use |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of communication with other family members and healthcare providers
기간: Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Questions to understand caregiver involvement, support, and information flow |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Preference of feeding option
기간: Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Careful hand feeding, tube feeding, or unsure |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
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Preparation for decision-making scale (treatment group only)
기간: One-Month Follow-Up; Three-Month Follow-Up
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Questions to assess the effect of the intervention by preparing for feeding option decision-making |
One-Month Follow-Up; Three-Month Follow-Up
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The Feasibility of the CMCFODA study as measured by recruitment rates and the proportion of participants that decline participation.
기간: Enrollment
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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.
기간: Enrollment, One-Month Follow-Up,Three-Month Follow-Up
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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
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Acceptability of the decision aid and decision coaching (only for the treatment group)
기간: One Month Follow-Up
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We will use developed questions to measure the acceptability of this intervention |
One Month Follow-Up
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .