- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06817122
The "Let's Talk Tech" Tool to Support Decision Making About Technology Use
Mechanistic Study of the "Let's Talk Tech" Dyadic Behavioral Intervention to Support Decision Making About Technology Use
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98105
- University of Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
No Intervention: Usual care
This control group will receive usual care, which means they will complete no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technology awareness
Time Frame: 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
Time Frame: 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"].
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baseline and 2-week post-test
|
|
Perception of PLWD/MCI's technology understanding
Time Frame: 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"].
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baseline and 2-week post-test
|
|
Satisfaction with dyadic communication about technology
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
|
Preparedness to make technology decisions
Time Frame: 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.
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baseline, 2-week post-test and 3 months
|
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Decisional Conflict Scale
Time Frame: 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)
Time Frame: 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.
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baseline, 2-week post-test and 3 months
|
|
Had conversation about technology
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shared technology preferences
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Clara Berridge, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neurocognitive Disorders
- Cognition Disorders
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Hemic and Lymphatic Diseases
- Cognitive Dysfunction
- Lymphoma, Follicular
- Dementia
Other Study ID Numbers
- STUDY00020570
- 1P30AG086562-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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