Let's Talk Tech for Mild Cognitive Impairment

Overseen By Clara Berridge, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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. 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 three surveys. The second survey will be taken within 2 weeks of the first and the last survey will be taken 3 months after the first.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Let's Talk Tech for mild cognitive impairment?

Research shows that technology-based cognitive training, like the TECH intervention using tablets, is feasible and well-received by older adults with mild cognitive impairment, suggesting it could be an effective way to engage and improve cognitive function. ^{1 2 3 4 5}

Is Let's Talk Tech safe for people with mild cognitive impairment?

There is no specific safety data available for Let's Talk Tech, but studies on similar technologies for people with mild cognitive impairment suggest they are generally well-received and safe to use. ^{5 6 7 8 9}

How is the Let's Talk Tech treatment different from other treatments for mild cognitive impairment?

Let's Talk Tech is unique because it is a self-administered tool designed to help people with mild dementia and their care partners make informed decisions about using technology for care. It focuses on educating and facilitating communication about technology use, which is a novel approach compared to traditional treatments. ^{4 9 10 11 12}

Research Team

Clara Berridge, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for people aged 55 or older with mild cognitive impairment (MCI) or mild dementia, and their primary support person who is at least 18. Both must speak English and be able to use the 'Let's Talk Tech' tool together.

Inclusion Criteria

I am 55 years old or older.

My study partner and I can attend the test together.

I have been diagnosed with mild cognitive impairment or mild dementia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Let's Talk Tech web application together with their study partner

1 hour

1 session (self-administered)

Assessment

Participants complete surveys to assess technology awareness, understanding, and decision-making preparedness

3 months

3 surveys (baseline, 2 weeks, 3 months)

Follow-up

Participants are monitored for changes in preparedness and decisional conflict regarding technology use

3 months

Treatment Details

Interventions

• Let's Talk Tech

Trial Overview 'Let's Talk Tech' is a web application designed to educate users about home care technologies for those with memory issues. The study compares this tool against usual care to see if it improves decision-making confidence regarding technology use.

Participant Groups

Group I: Let's Talk Tech intervention Experimental Treatment 1 Intervention

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

Group II: Usual care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

There is currently no pharmacological treatment to stop the progression of Alzheimer's disease and dementia, making Mild Cognitive Impairment (MCI) a critical area for research and intervention.

Recent studies have focused on using information and communication technologies, including sensors, personal devices, and robots, to assess and assist patients with MCI, but there is still significant potential for improvement in these technological solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Technological Solutions for Assessment, Treatment, and Assistance in Mild Cognitive Impairment. Mancioppi, G., Fiorini, L., Timpano Sportiello, M., et al.[2020]

A study involving 16 participants aged 65 and older showed that older adults with mild cognitive impairment (MCI) found physical activity apps like Sworkit® and 7-Minute Workout® easy to use and enjoyable, with 100% of participants smiling while playing these games.

In contrast, cognitive training apps were less engaging, with only 35% of participants smiling, indicating that physical activity apps may be more appealing and effective for this population, highlighting the importance of user feedback in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usability of Physical Activity and Cognitive Training Applications in People With Mild Cognitive Impairment. Smith, L., Argentina, V.[2021]

In a pooled analysis of safety data from 1054 participants in two Phase 3 Alzheimer's disease studies, the overall annualized discontinuation rate was 21.6%, with 8.2% of participants discontinuing due to adverse events, highlighting the challenges of maintaining participants in clinical trials.

Adverse events such as falls, pneumonia, and atrial fibrillation were more common in older participants, indicating that age significantly influences safety outcomes in Alzheimer's disease trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and dropouts in Alzheimer's disease studies: what can we learn? Henley, DB., Sundell, KL., Sethuraman, G., et al.[2015]

In a study of 123 patients treated with donepezil for Alzheimer's dementia, 21% discontinued treatment due to adverse events (AEs), highlighting the need for careful monitoring during the initial months of therapy.

The most common AEs leading to discontinuation were nausea/vomiting, diarrhea, and loss of appetite, indicating that these side effects are significant considerations in the management of patients on donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. Carøe, TK., Moe, C.[2018]

The pilot study of the 'Let's Talk Tech' intervention showed significant improvements in care partners' understanding of technology and their preparedness to make decisions about its use in dementia care, involving 29 dyads living with mild Alzheimer's disease.

Participants reported that the intervention facilitated meaningful conversations about technology preferences, indicating its potential to enhance communication and decision-making in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy of Let's Talk Tech: Technology Use Planning for Dementia Care Dyads. Berridge, C., Turner, NR., Liu, L., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Novel Technological Solutions for Assessment, Treatment, and Assistance in Mild Cognitive Impairment. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The Development and Feasibility of TECH: Tablet Enhancement of Cognition and Health, a Novel Cognitive Intervention for People with Mild Cognitive Impairment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Technology-based cognitive training and rehabilitation interventions for individuals with mild cognitive impairment: a systematic review. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Digital Assistive Technology to Support Everyday Living in Community-Dwelling Older Adults with Mild Cognitive Impairment and Dementia. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Usability of Physical Activity and Cognitive Training Applications in People With Mild Cognitive Impairment. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events and dropouts in Alzheimer's disease studies: what can we learn? [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Designing ICTs for Users with Mild Cognitive Impairment: A Usability Study. [2020]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Usability and acceptability of technology for community-dwelling older adults with mild cognitive impairment and dementia: a systematic literature review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Preliminary Efficacy of Let's Talk Tech: Technology Use Planning for Dementia Care Dyads. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Are people with mild dementia able to (re)learn how to use technology? A literature review. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Attitudes and Use of Information and Communication Technologies in Older Adults With Mild Cognitive Impairment or Early Stages of Dementia and Their Caregivers: Cross-Sectional Study. [2020]