文化的に適応された意思決定支援介入：中国系アメリカ人の認知症介護者を食事関連の意思決定で支援する
中国系アメリカ人の認知症介護者が食事関連の決定を支援するための文化的に適応された意思決定支援介入
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yaolin Pei, Ph.D.
- 電話番号：8064708689
- メール：yaolin.pei@austin.utexas.edu
研究場所
-
-
Texas
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Austin、Texas、アメリカ、78712
- 募集
- School of Nursing at UT Austin
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コンタクト：
-
主任研究者：
- Yaolin Pei, PhD
-
コンタクト：
- Yaolin Pei, PhD
- 電話番号：8064708689
- メール：yaolin.pei@austin.utexas.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Participation Group
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|
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実験的：Intervention/Treatment Group
|
Participants in the treatment group will receive the CMCFODA via zoom meeting or another secure video conferencing platform and an individualized decision coaching. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision conflict
時間枠：Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
SURE test for decisional conflict (0-4) |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Knowledge of feeding options and dementia
時間枠：Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions to assess knowledge about feeding options and dementia |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Expectations of tube feeding
時間枠：Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions about understanding differing expectations regarding feeding tube use |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of communication with other family members and healthcare providers
時間枠：Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Questions to understand caregiver involvement, support, and information flow |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Preference of feeding option
時間枠：Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
Careful hand feeding, tube feeding, or unsure |
Baseline; One-Month Follow-Up; Three-Month Follow-Up
|
|
Preparation for decision-making scale (treatment group only)
時間枠：One-Month Follow-Up; Three-Month Follow-Up
|
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.
時間枠：Enrollment
|
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.
時間枠：Enrollment, One-Month Follow-Up,Three-Month 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)
時間枠：One Month Follow-Up
|
We will use developed questions to measure the acceptability of this intervention |
One Month Follow-Up
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。