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Behavioural Intervention

Mobile Telehealth for Alzheimer's Disease

N/A
Recruiting
Led By Richard J Holden, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months,12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a mobile health app can reduce the burden of unpaid Hispanic caregivers of dementia patients and improve BPSD symptoms in the care recipients.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves using mobile health applications rather than medications, traditional side effects are not expected. However, users may experience stress or frustration if they encounter difficulties using the technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months,12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Behavioral Intention Questionnaire
System Usability Scale
Secondary study objectives
Qualitative Interview
Other study objectives
App Use
Caregiver Self-efficacy
Caregiver Social Support

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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."

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,844 Total Patients Enrolled
8 Trials studying Caregiver Burden
4,094 Patients Enrolled for Caregiver Burden
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,817 Total Patients Enrolled
34 Trials studying Caregiver Burden
4,768 Patients Enrolled for Caregiver Burden
Richard J Holden, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
906 Total Patients Enrolled
1 Trials studying Caregiver Burden
200 Patients Enrolled for Caregiver Burden
Malaz Boustani, MDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
751 Total Patients Enrolled
1 Trials studying Caregiver Burden
200 Patients Enrolled for Caregiver Burden
~10 spots leftby Jul 2025