テクノロジーの使用に関する意思決定をサポートするための「テクノロジーを話す」ツール
テクノロジーの使用に関する意思決定をサポートするために、「テクノロジーを話す」ダイアディック行動介入の機械的研究
The goal of this research is to educate people about different technologies to support care at home when someone is experiencing memory difficulties. "Let's Talk Tech" is a new tool to educate people about technologies commonly used to support care and monitor safety, and help families talk about their feelings about them to understand each other's perspectives. The goal of this clinical trial is to learn if "Let's Talk Tech" helps people feel more prepared to make decisions about technologies.
Researchers will compare Let's Talk Tech to usual care (no intervention) to see if Let's Talk Tech increases peoples' preparedness and confidence to make decisions about technologies.
All participants will:
- Use the Let's Talk Tech web application together with their study partner that takes up to an hour or do nothing.
- Complete two surveys. The second survey will be taken within 2 weeks of the first.
One participant in each pair will also take a 3rd short survey 3 months after the first.
調査の概要
詳細な説明
The goal of this research is to help families understand digital health technology options to support dementia care at home so they can negotiate immediate decisions and future use in an informed way. This is a mechanism-focused trial of Let's Talk Tech (LTT), a single-use, self-administered intervention in the form of a web application. It targets education and interpersonal communication processes to enable informed decision making and planning for technology use that relieves care partners of the burden of making decisions without awareness of the person's preferences. Participants are people living with mild Alzheimer's disease (AD) and AD-related dementias (PLWD) or mild cognitive impairment (MCI) and a care partner. The 120 enrolled dyads (60 per study group) will be randomly assigned to receive either the intervention or usual care control. The intervention is self-administered. All participants will complete measures at baseline and at post-test (2 weeks), and care partners will also complete them 3 months later. Aim 1 will test if LTT compared with usual care improves the hypothesized mechanisms of change that are care partners' technology awareness, understanding, communication satisfaction, and intention to honor the PLWD/MCI's preferences, as well as both care partner- and PLWD/MCI-reported dyadic alignment. Aim 2 will examine if and how those hypothesized mechanisms of change improve the post-test and 3-month primary outcomes of care partner preparedness, decisional conflict, and decision making confidence, and secondary outcomes of PLWD/MCI and care partner sharing of technology preferences beyond the dyad and their confidence that PLWD/MCI's preferences will be honored. Exploratory Aim 3 will examine how, with whom, and for what purpose dyad members share technology preferences and explore factors that vary for those who shared with providers vs. family/friends, with the hope of learning how to expand the reach of this intervention to activate dyads' entire care networks.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98105
- University of Washington
-
-
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 for Patients:
- have mild cognitive impairment (MCI) or mild dementia
- age 55 or older
- able to understand and speak English
Inclusion Criteria for Co-participants:
- be identified by the patient as their primary support person
- age 18 or older
- able to understand and speak English
- able to complete LTT together with their study partner at the same time
Exclusion Criteria:
- None
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：他の
- 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 |
|---|---|
|
実験的：Let's Talk Tech intervention
The intervention group will complete the single use self-administered Let's Talk Tech intervention together as a dyad. |
Let's Talk Tech is a self-administered dyadic education and communication tool delivered as a web application to support shared decision making about technology use. |
|
介入なし：Usual care
This control group will receive usual care, which means they will complete no intervention. |
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 |
|---|---|---|
|
Preparedness to make technology decisions
時間枠：baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. Participant rates on a 5-point Likert scale [1="Strongly agree" to 5="Strongly disagree"] how much they agree with the statement that they feel prepared to make decisions about technology use for their study partner. |
baseline, 2-week post-test and 3 months
|
|
Decisional Conflict Scale
時間枠：baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. The Decisional Conflict Scale is a 16-item scale with 5 response categories [0= "Strongly agree" to 4="Strongly disagree"]. Higher scores reflect higher decisional conflict in decision making. |
baseline, 2-week post-test and 3 months
|
|
Decision Making Confidence Scale (adapted)
時間枠：baseline, 2-week post-test and 3 months
|
This is one of the three primary outcomes that are not mechanisms of change variables. This is a six-item scale with 5 response categories [0="Not confident at all" to 4= "Very confident"]. Higher scores reflect higher confidence in decision making. |
baseline, 2-week post-test and 3 months
|
|
Technology awareness
時間枠：baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very aware" to 5="Very unaware"] how aware they are about technologies available to support their partner's care and safety. |
baseline and 2-week post-test
|
|
Technology understanding
時間枠：baseline and 2-week post-test
|
4 items assess perceived understanding of each of 4 technologies featured in the intervention [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Perception of PLWD/MCI's technology understanding
時間枠：baseline and 2-week post-test
|
4 items assess care partner's perception of how well their study partner understands of each of 4 technologies featured in the intervention [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Satisfaction with dyadic communication about technology
時間枠：baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very satisfied" to 5="Very dissatisfied"] how satisfied they are with their discussion with their study partner about using technology to support their care or safety. |
baseline and 2-week post-test
|
|
Intention to honor preferences
時間枠：baseline and 2-week post-test
|
Participant rates on a 5-point Likert scale [1="Very likely" to 5="Very unlikely"] how likely they are to honor their partner's preferences for how technology is used in their care. |
baseline and 2-week post-test
|
|
Dyadic alignment about technology use
時間枠：baseline and 2-week post-test
|
Participant is asked how much they agree with their partner about using technologies to support their care [1="Not at all" to 5="Completely"]. |
baseline and 2-week post-test
|
|
Had conversation about technology
時間枠：baseline and 2-week post-test
|
Participant answers yes, no or unsure if they've ever had a conversation with their study partner about technology to support care or safety. |
baseline and 2-week post-test
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Shared technology preferences
時間枠：baseline, 2-week post-test and 3 months
|
Participant answer yes or no if they have ever shared the PLWD/MCI's preferences about technologies to support their care with anyone else. |
baseline, 2-week post-test and 3 months
|
|
Confidence preferences will be honored
時間枠：baseline, 2-week post-test and 3 months
|
Participant rates on a 5-point Likert scale [1=Strongly agree to 5=Strongly disagree] about their belief the PLWD/MCI's choices about these technologies will be honored. |
baseline, 2-week post-test and 3 months
|
|
Satisfaction with involvement of primary participant in technology use decisions
時間枠：baseline, 2-week post-test and 3 months
|
Participant rates on a 5-point Likert scale [1="Very satisfied" to 5="Very dissatisfied"] how satisfied they are with how involved the primary participant is in decisions about technology to support their care. |
baseline, 2-week post-test and 3 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Clara Berridge, PhD、University of Washington
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00020570
- 1P30AG086562-01 (米国 NIH グラント/契約)
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
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