Mobile Telehealth for Alzheimer's Disease

(I-CARE 2 Trial)

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: 6

Duration: 12 months

184 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Brain CareNotes to determine if it can reduce stress for unpaid caregivers of individuals with Alzheimer's or similar types of dementia. It also examines how the app might assist with the behavior and mood issues of those they care for. Participants will be divided into two groups: one using the Brain CareNotes app and the other using an educational app. The trial seeks unpaid caregivers who are the primary support for someone with dementia and who live in the community. As an unphased trial, this study offers caregivers an opportunity to explore innovative support tools that could enhance their caregiving experience.

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 prior data suggests that the Brain CareNotes app is safe for caregivers and patients with dementia?

Research has shown that people generally have a good experience using the Brain CareNotes app. One study found that caregivers of Alzheimer's patients could use it without major problems. The study examined usage frequency, ease of use, and user satisfaction. Results were positive, with no significant issues or negative effects reported. This suggests that the Brain CareNotes app is safe for caregivers, with no known risks associated with its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brain CareNotes App for Alzheimer's disease because it offers a unique approach compared to traditional treatments like medications or in-person therapy sessions. This app provides personalized support and guidance through mobile telehealth, allowing patients to access care conveniently from their own homes. Unlike standard treatments that mainly focus on slowing cognitive decline, the Brain CareNotes App emphasizes enhancing patient engagement and communication, which could lead to improved quality of life. This innovative use of technology might make managing Alzheimer's disease more accessible and effective for patients and caregivers alike.

What evidence suggests that the Brain CareNotes app is effective for Alzheimer's disease?

Research has shown that the Brain CareNotes app, available to participants in this trial, may benefit those caring for Alzheimer's patients. Studies found that caregivers using the app rated it highly, with a score of 72.5 out of 100, considered "Good to Excellent." Additionally, 85% of caregivers continued using the app, indicating high satisfaction. The app provides educational support to help caregivers manage stress and enhance their caregiving skills. These early results suggest that Brain CareNotes could reduce caregivers' workload and help manage patients' behavioral symptoms. Another group in this trial will use the Attention Control App, which serves as an active comparator. ^{1 2 5 6 7}

Who Is on the Research Team?

Malaz Boustani, MD, MPH

Principal Investigator

Indiana University

Richard J Holden, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Brain CareNotes
• Dementia Guide Expert

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.

How Is the Trial Designed?

Group I: Brain CareNotes App Experimental Treatment 1 Intervention

Group II: Attention Control App Active Control 1 Intervention

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+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10841172/

Feasibility and preliminary efficacy of Brain CareNotes Brain CareNotes is a mobile telehealth app created for informal ADRD caregivers. Brain CareNotes delivers 24/7 psychoeducation and caregiver ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37706540/

Feasibility and preliminary efficacy of Brain CareNotes - PubMed Among randomized individuals, there was a retention rate of 85% and data completion was attained for 81.5% of those allocated to usual care and 88.5% of those ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S1929074825005554

Mobile Telehealth Intervention to Support Care Partners of ... Technology caregiver intervention for Alzheimer's disease (I-CARE): feasibility and preliminary efficacy of Brain CareNotes. J Am Geriatr Soc, 71 (12) (2023) ...

4. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.18591

Technology caregiver intervention for Alzheimer's disease (I ... Mean caregiver-reported app usability at 6 months was 72.5 (IQR 70.0–90.0) on the System Usability Scale—considered “Good to Excellent”—and user ...

5. researchprotocols.org researchprotocols.org/2025/1/e73387

Mobile Telehealth Intervention to Support Care Partners of ... This study is a randomized controlled trial of 160 ADRD care partners to evaluate the real-world efficacy of Brain CareNotes on the primary ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03119259

Technology Intervention to Support Caregiving for ... The specific aims of this study are 1) to test the trial and intervention feasibility of Brain Care Notes (BCN) app, 2) To estimate the effect size of BCN ...

7. agsjournals.onlinelibrary.wiley.com agsjournals.onlinelibrary.wiley.com/doi/pdf/10.1111/jgs.18591

Feasibility and preliminary efficacy of Brain CareNote The primary aim of the current pilot study was to examine recruitment rate, data completion, usability, acceptance, and use of a mobile ...