Mobile Telehealth for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Jordan R Hill, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Care recipient in nursing home, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Brain CareNotes provides support for management of the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 10 months, the trial will enroll 40 Hispanic caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Brain CareNotes, Brain CareNotes App, I-CARE 2 Intervention, Dementia Guide Expert for Alzheimer's Disease?

Research shows that digital health interventions, like smartphone apps, can improve care for Alzheimer's patients by providing disease management and caregiver support. Although current apps have limited functions, they have the potential to benefit caregivers and patients by offering information and coordination tools. ^{1 2 3 4 5}

Is the mobile telehealth app for Alzheimer's disease safe for humans?

The available research on mobile telehealth apps like Brain CareNotes and I-CARE for Alzheimer's disease primarily focuses on usability and caregiver support, but does not report any specific safety concerns for humans. ^{2 6 7 8 9}

How is the Brain CareNotes treatment different from other Alzheimer's treatments?

Brain CareNotes is unique because it is a mobile telehealth app designed to reduce caregiver burden and manage behavioral and psychological symptoms of dementia, offering a digital platform for communication and coordination among care networks, unlike traditional treatments that focus solely on medication or in-person interventions. ^{2 4 5 6 7}

Research Team

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University

Richard J Holden, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for unpaid Hispanic caregivers, aged 18 or older, who look after someone with Alzheimer's disease or a related dementia and live in the community. Caregivers must be English literate and able to use a mobile touchscreen device. Those caring for individuals in nursing homes or participating in another conflicting clinical trial cannot join.

Inclusion Criteria

You are the main unpaid caregiver of a Hispanic person diagnosed with Alzheimer's disease or related dementias, and they are receiving care at home.

English literate

Exclusion Criteria

Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)

Care recipient is a permanent resident of an extended care facility (nursing home)

Involvement in another clinical trial that would prevent or interfere with study objectives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Brain CareNotes app or an attention control education-only app for 12 months

12 months

Usage reminders and app interactions

Follow-up

Participants are monitored for usability, acceptability, and needs met or unmet by the intervention

12 months

Assessments at 3, 6, and 12 months

Treatment Details

Interventions

• Brain CareNotes
• Dementia Guide Expert

Trial Overview The study tests Brain CareNotes, a mobile app designed to help manage caregiver burden and symptoms of dementia patients. Participants will either use this app or an education-only app as control for one year, with reminders to ensure consistent usage.

Participant Groups

Group I: Brain CareNotes Experimental Treatment 1 Intervention

The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.

Group II: Attention Control App Active Control 1 Intervention

Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."

Brain CareNotes is already approved in United States for the following indications:

Approved in United States as Brain CareNotes for:

• Management of behavioral and psychological symptoms of dementia (BPSD)
• Support for unpaid caregivers of patients with dementia

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Age-related cognitive impairment (ARCI) is linked to underlying brain pathology, highlighting the need for early detection and personalized interventions to improve health span.

The Intelligent Technology Therapy Assistant (ITA) concept, exemplified by platforms like the Guttman Neuro Personal Trainer® and the Barcelona Brain Health Initiative app, aims to enhance access to clinical expertise while maintaining a personal connection between patients and clinicians, potentially improving the effectiveness of cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. Gomes-Osman, J., Solana-Sánchéz, J., Rogers, E., et al.[2023]

There is a significant need for smartphone-based interventions to support caregivers of the 5.4 million people with Alzheimer's disease, as current apps available for caregivers have limited functions and do not adequately address their complex needs.

Research indicates that there is a lack of tailored caregiving apps for Hispanic populations, highlighting a gap in accessibility and support for diverse caregiver communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. Brown, EL., Ruggiano, N., Li, J., et al.[2020]

The ABILITY digital-health intervention showed higher adherence (81% vs. 62%) and better perceived fit of demands and skills compared to treatment as usual (TAU), indicating it is an effective home-based program for individuals in the Alzheimer's disease continuum.

Participants in the ABILITY group demonstrated significant improvements in global cognitive functions, particularly in language, executive functions, and memory, with lasting benefits observed at a 1-year follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A digital health home intervention for people within the Alzheimer's disease continuum: results from the Ability-TelerehABILITation pilot randomized controlled trial. Rossetto, F., Isernia, S., Realdon, O., et al.[2023]

The CareVirtue journal feature was effectively used by care networks of Alzheimer's patients for 60 days, facilitating communication through information sharing, strategy development, and feedback among caregivers.

Primary caregivers found the journal useful at multiple levels, enhancing individual support and strengthening care network relationships, highlighting the importance of caregiver-centered technologies in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It made me feel like I wasn't alone in the darkness": exploring dementia care network communication and coordination through a digital health platform. Linden, A., Jolliff, A., Gonzalez, D., et al.[2023]

A review of 36 mobile applications related to Alzheimer's disease and related dementias found that most apps focus on caregiving (62.1%) and disease management (55.6%), indicating a strong emphasis on supporting caregivers and managing the disease.

The overall quality of these apps was acceptable, with those developed by healthcare-related organizations scoring higher than those from non-healthcare developers, suggesting that collaboration between ADRD experts and tech developers could enhance the effectiveness and reliability of these resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the Content and Quality of Mobile Applications About Alzheimer's Disease and Related Dementias. Choi, SK., Yelton, B., Ezeanya, VK., et al.[2023]

The pilot study involving 53 patient-caregiver dyads showed that the Brain CareNotes mobile app had good usability and acceptance, with 85%-90% of caregivers willing to continue using it after 6 months.

While the app did not show statistically significant differences in reducing caregiver burden and behavioral symptoms of dementia, there were observed reductions in caregiver distress and BPSD scores, suggesting potential benefits that warrant further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology caregiver intervention for Alzheimer's disease (I-CARE): Feasibility and preliminary efficacy of Brain CareNotes. Rodriguez, MJ., Kercher, VM., Jordan, EJ., et al.[2023]

I-CARE is a user-friendly tablet application designed to help caregivers activate and engage individuals with dementia, requiring no special training, which enhances the quality of care provided.

The system personalizes activation content based on user feedback and past interactions, allowing caregivers to track progress and connect with professionals for real-time support, ultimately fostering community involvement in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I-CARE-An Interaction System for the Individual Activation of People with Dementia. Schultz, T., Putze, F., Steinert, L., et al.[2021]

The Health App Review Tool (HART) was developed to help individuals with Alzheimer's disease and their caregivers find suitable mobile applications for health and wellness, and it underwent significant revisions based on stakeholder feedback.

After gathering input from 13 participants, the HART was streamlined from 106 items to just 17, improving its clarity, conciseness, and overall understandability, making it more user-friendly for its target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement of Health App Review Tool (HART) through stakeholder interviews: HART 2.0. Faieta, J., Bourassa, J., Best, K.[2023]

WeCareAdvisor™ is a web-based platform designed to help families manage dementia-related behavioral symptoms by providing knowledge, daily tips, and tailored treatment plans, and is currently being tested in a randomized trial with 57 caregivers.

The trial aims to assess the platform's acceptability and usability, as well as its immediate impact on caregiver confidence and the frequency of behavioral symptoms, with participants receiving support through check-in calls during the treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. Gitlin, LN., Kales, HC., Marx, K., et al.[2022]

References

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

Aging in the Digital Age: Using Technology to Increase the Reach of the Clinician Expert and Close the Gap Between Health Span and Life Span. [2023]

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

Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. [2020]

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

A digital health home intervention for people within the Alzheimer's disease continuum: results from the Ability-TelerehABILITation pilot randomized controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

"It made me feel like I wasn't alone in the darkness": exploring dementia care network communication and coordination through a digital health platform. [2023]

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

Review of the Content and Quality of Mobile Applications About Alzheimer's Disease and Related Dementias. [2023]

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

Technology caregiver intervention for Alzheimer's disease (I-CARE): Feasibility and preliminary efficacy of Brain CareNotes. [2023]

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

I-CARE-An Interaction System for the Individual Activation of People with Dementia. [2021]

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

Refinement of Health App Review Tool (HART) through stakeholder interviews: HART 2.0. [2023]

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

A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. [2022]