Mobile Telehealth for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
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 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.
12345Is 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.
26789How 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.
24567Eligibility 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
I am 18 years old or older.
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
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
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Brain CareNotesExperimental Treatment1 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 AppActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniversityBloomington, IN
Mount Sinai Medical CenterMiami Beach, FL
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
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]Age-related cognitive impairment (ARCI) has a profound impact on individuals, families, health care systems, and societies at large. Evidence suggests that ARCI is the consequence of underlying brain pathology. Therefore, efforts to minimize the impact of ARCI and thus closing the gap between health span and life span, which has widened in recent years, requires early detection and timely deployment of targeted, personalized interventions. Access to clinical experts is limited and technology screening and assessment methods are thus appealing. However, as traditionally implemented patients were deprived of the benefit of personalized connection with a clinician, which is particularly critical for the prescription and to ensure the adherence to and ultimate success of therapeutic interventions. We present the concept of Intelligent Technology Therapy Assistant (ITA) as a scalable solution that increases the reach of clinical experts while sustaining the personal connection between each patient and their clinician. We illustrate ITA with the "Guttman Neuro Personal Trainer"®, a tele-rehabilitation platform that provides neuropsychological evaluation and care, and the Barcelona Brain Health Initiative (BBHI) multimodal intervention coaching app, a mobile-based platform that provides lifestyle coaching support in domains related to brain health. In addition, we discuss the translation of these models to a large-scale enterprise with Linus Health. To this end, we conclude with a discussion of challenges and opportunities to move the field forward.
Smartphone-Based Health Technologies for Dementia Care: Opportunities, Challenges, and Current Practices. [2020]Most of the 5.4 million people affected by Alzheimer's disease and other forms of dementia (AD) are noninstitutionalized, receiving care by unpaid family caregivers and medically managed by a primary care provider (PCP). Health Information Technology has been recognized for its potential in improving efficiency and quality of AD care and support for AD caregivers. Simultaneously, smartphone technologies have become an increasingly common way to deliver physical and behavioral health care. However, little is known about how smartphone technologies have been used to support AD caregiving and care. This article highlights the current need for smartphone-based interventions for AD and systematically identified and appraised current smartphone apps targeting and available for AD caregivers. Findings indicate that individual available apps have limited functions (compared with the complex needs of caregivers) and little has been done to extend AD caregiving apps to Hispanic populations. Implications for research, practice, and policy are discussed.
A digital health home intervention for people within the Alzheimer's disease continuum: results from the Ability-TelerehABILITation pilot randomized controlled trial. [2023]This study tested the efficacy of digital-health home intervention for people within the Alzheimer's disease (AD)-continuum.
"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]To explore the use of a shared communication and coordination platform-the CareVirtue journal feature-for care networks of people living with Alzheimer's disease and related dementias to inform the design of care network support technologies.
Review of the Content and Quality of Mobile Applications About Alzheimer's Disease and Related Dementias. [2023]This study reviewed the content of mobile applications (apps) providing Alzheimer's disease or related dementias (ADRD) information and assessed quality of the apps. Characteristics, content, and technical aspects of 36 apps in the U.S. Google Play Store and App Store were coded, and quality of the apps was evaluated using the Mobile Application Rating Scale. Caregiving (62.1%) and disease management (55.6%) content was frequently provided. Few apps had an app community (8.3%) or a reminder function (8.3%). Overall, quality of the apps was acceptable; apps by health care-related developers had higher quality scores than those by non-health care-related developers. This analysis showed that ADRD-related apps provide a range of content and have potential to benefit caregivers, individuals with ADRD, health care providers, and the general public. Collaboration of ADRD experts and technology experts is needed to provide evidence-based information using effective technical functions that make apps to meet users' needs.
Technology caregiver intervention for Alzheimer's disease (I-CARE): Feasibility and preliminary efficacy of Brain CareNotes. [2023]The primary aim of the current pilot study was to examine enrollment rate, data completion, usability, acceptance and use of a mobile telehealth application, Brain CareNotes. A secondary aim was to estimate the application's effect in reducing caregiver burden and behavioral and psychological symptoms related to dementia (BPSD).
I-CARE-An Interaction System for the Individual Activation of People with Dementia. [2021]I-CARE is a hand-held activation system that allows professional and informal caregivers to cognitively and socially activate people with dementia in joint activation sessions without special training or expertise. I-CARE consists of an easy-to-use tablet application that presents activation content and a server-based backend system that securely manages the contents and events of activation sessions. It tracks various sources of explicit and implicit feedback from user interactions and different sensors to estimate which content is successful in activating individual users. Over the course of use, I-CARE's recommendation system learns about the individual needs and resources of its users and automatically personalizes the activation content. In addition, information about past sessions can be retrieved such that activations seamlessly build on previous sessions while eligible stakeholders are informed about the current state of care and daily form of their protegees. In addition, caregivers can connect with supervisors and professionals through the I-CARE remote calling feature, to get activation sessions tracked in real time via audio and video support. In this way, I-CARE provides technical support for a decentralized and spontaneous formation of ad hoc activation groups and fosters tight engagement of the social network and caring community. By these means, I-CARE promotes new care infrastructures in the community and the neighborhood as well as relieves professional and informal caregivers.
Refinement of Health App Review Tool (HART) through stakeholder interviews: HART 2.0. [2023]The Health App Review Tool (HART) is a novel assessment designed to match users with Alzheimer's disease or related dementias (ADRD) and caregivers to mobile applications that support health and wellness. The objectives of this study were to gather stakeholder feedback on the HART and then to implement revisions. Thirteen participants completed in-depth Think Aloud interviews. Participants shared qualitative feedback on each HART item. Participant feedback was analyzed via in-depth video-audio review. Feedback was implemented as actionable HART revisions. On average, the majority of participants rated items as "adequate"; however, qualitative findings indicated the need for improvement in conciseness, clarity, and understandability. Conciseness was addressed by combining related concepts into multi-items, clarity through the addition of specific examples, and understandability through improved verbiage. The HART has been refined from 106 items to 17 items through extensive revisions to the clarity, conciseness, and explanations provided throughout the assessment.
A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. [2022]Dementia-related behavioral symptoms are challenging clinical features occurring across etiologies and disease progression. They are associated with increased healthcare utilization, nursing home placement, family upset and burden. Families typically manage behavioral symptoms without requisite knowledge, skills and guidance. We designed WeCareAdvisor™ as an easy-to-use, evidence-informed web-based platform. It provides families knowledge about dementia, daily tips, and a systematic approach to describe behaviors, investigate modifiable contributors, create treatment plans (WeCareAdvisor™ Prescription) consisting of management tips tailored to symptom presentation, and evaluate effectiveness. WeCareAdvisor™ is being tested in a randomized trial to assess acceptability, usability and immediate impact on caregiver confidence managing and upset with behavioral symptoms, and secondarily, frequency of behavioral occurrences. Fifty-seven caregivers will be enrolled from communities and medical clinics at two sites (University of Michigan; Johns Hopkins University). Families reporting behavioral symptoms in a telephone screen are consented and interviewed at home. Following the interview, an envelope is opened by interviewers to reveal group assignment (immediate vs one-month delayed treatment group). Those receiving WeCareAdvisor™ immediately are provided an iPad and instruction in its use; those in the delayed treatment group are informed of next study steps. All caregivers are reassessed at home one month from baseline. The delayed treatment group then receives iPad instructions and are re-interviewed one month thereafter. During treatment phase, participants receive 3 weekly check-in calls to encourage tool use and troubleshoot. Key outcomes include number of times using WeCareAdvisor™ and for which behaviors, self-efficacy and upset managing behavioral symptoms, and frequency of behavioral occurrences. Clinical trial registration #: NCT02420535.