Mobile Telehealth for Alzheimer's Disease

(I-CARE 2 Trial)

Recruiting at 1 trial location

Overseen By Miriam J Rodriguez, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Indiana University

Disqualifiers: Care recipient in nursing home, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if the Brain CareNotes app can reduce stress for unpaid caregivers of dementia patients and improve patient symptoms. The app provides practical advice, reminders, and emotional support to help caregivers manage their tasks.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your 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 technologies, like smartphone apps, can improve care for Alzheimer's patients and support caregivers by providing disease management and caregiving resources. While specific data on Brain CareNotes and related apps is limited, similar technologies have shown potential benefits in enhancing care coordination and providing support to caregivers. ^{1 2 3 4 5}

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

The studies reviewed focus on the usability and effectiveness of mobile telehealth applications for Alzheimer's caregivers, but they do not provide specific safety data. However, these apps are generally designed to be user-friendly and supportive, suggesting they are safe for use by caregivers. ^{1 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. ^{1 3 4 8 9}

Research Team

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University

Richard J Holden, PhD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 who are the main unpaid caregivers for someone with Alzheimer's or a related dementia. The caregiver must be able to read English and care for someone who lives in the community and sees their doctor regularly.

Inclusion Criteria

I am the main caregiver for someone with Alzheimer's or related dementia, and they live at home.

I am a caregiver, over 18, and can read and understand English.

Exclusion Criteria

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

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

Trial 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

Baseline, 6 months, and 12 months assessments

Follow-up

Participants are monitored for caregiver burden, patient BPSD, and other outcomes

12 months

Treatment Details

Interventions

• Brain CareNotes (Behavioural Intervention)
• Dementia Guide Expert (Behavioural Intervention)

Trial Overview The study tests Brain CareNotes, a mobile app designed to help caregivers manage the stress of caring for someone with dementia. Participants will either use this app or an education-only app as a control, with reminders to use it over a year.

Participant Groups

Group I: Brain CareNotes App Experimental Treatment 1 Intervention

Group II: Attention Control App Active Control 1 Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

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]

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]

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]

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]

References

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

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

2. 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]

3. 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]

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

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

5. 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]

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

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

7. 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]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

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