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临床试验/NCT06817122
NCT06817122已完成不适用

Mechanistic Study of the "Let's Talk Tech" Dyadic Behavioral Intervention to Support Decision Making About Technology Use

University of Washington1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2025年2月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
1
主要终点
Perception of PLWD/MCI's technology understanding

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Let's Talk Tech intervention

Experimental

The intervention group will complete the single use self-administered Let's Talk Tech intervention together as a dyad.

干预措施: Let's Talk Tech (Behavioral)

Usual care

No Intervention

This control group will receive usual care, which means they will complete no intervention.

结局指标

主要结局

Perception of PLWD/MCI's technology understanding

时间窗: 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 \[1="Not at all" to 5="Completely"\].

Decisional Conflict Scale

时间窗: 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.

Preparedness to make technology decisions

时间窗: 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.

Decision Making Confidence Scale (adapted)

时间窗: 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.

Had conversation about technology

时间窗: 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.

Dyadic alignment about technology use

时间窗: baseline and 2-week post-test

Participant is asked how much they agree with their partner about using technologies to support their care \[1="Not at all" to 5="Completely"\].

Technology awareness

时间窗: 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.

Technology understanding

时间窗: baseline and 2-week post-test

4 items assess perceived understanding of each of 4 technologies featured in the intervention \[1="Not at all" to 5="Completely"\].

Intention to honor preferences

时间窗: 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.

Satisfaction with dyadic communication about technology

时间窗: 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.

次要结局

  • Satisfaction with involvement of primary participant in technology use decisions(baseline, 2-week post-test and 3 months)
  • Confidence preferences will be honored(baseline, 2-week post-test and 3 months)
  • Shared technology preferences(baseline, 2-week post-test and 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Berridge

Associate Professor: School of Social Work

University of Washington

研究点 (1)

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