BRAIN App program to support communication and engagement for people with dementia
The BRAIN App (Phase 2 SBIR): Building Relationships Using Artificial Intelligence and Nostalgia
This program tests whether the BRAIN App can improve communication, mood, and quality of life for people aged 65 and older with dementia living in long-term care, with training and support for family members and staff.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Hopeful Aging Industry-sponsored |
| Locations | 1 site (Winchester, Massachusetts) |
| Trial ID | NCT06298474 on ClinicalTrials.gov |
What this trial studies
The project delivers a digital Cognitive Stimulation Therapy program via the BRAIN App to people living with dementia in nursing homes and assisted living facilities. A total of 120 residents (aged 65+) across eight long-term care sites will be split into experimental (n=60) and control (n=60) groups and measured before and after the intervention using a quasi-experimental pre-post design. Family members at experimental sites will use the app twice per month and staff will complete BRAIN training modules and use the platform to support sessions and report usability feedback. Key outcomes include resident quality of life, responsive behaviors, and relationship functioning between residents, professional care partners, and family members.
Who should consider this trial
Good fit: Ideal candidates are people aged 65 or older with a clinical diagnosis of dementia who can speak conversational English and live in one of the participating long-term care facilities.
Not a fit: Patients who are completely unable to communicate verbally, have serious uncorrected visual or hearing impairments, or show signs of rapid decline over the past three months are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could improve quality of life, reduce behavioral symptoms, and strengthen relationships between people living with dementia and their caregivers.
How similar studies have performed: Cognitive Stimulation Therapy has shown improvements in cognition and quality of life in prior trials, but delivering CST via a dedicated app is relatively novel though Phase I pilot work informed this Phase II effort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 65+ years old * Clinical diagnosis of dementia (any type) * Able to speak conversational English Exclusion Criteria: * Completely unable to communicate verbally * Serious visual or hearing impairments * Signs of rapid decline over the last three months (based upon staff report)
Where this trial is running
Winchester, Massachusetts
- Hopeful Aging — Winchester, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.