Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIndiana University

About this trial

The purpose of this study is to test the usefulness and the effect of Smart Virtual Reminiscence (SVR) therapy intervention on the Behavioral and Psychological Symptoms of Dementia (BPSD) of patients with Alzheimer's Disease and Related Dementias (ADRD).

SVR is designed to help older adults improve their psychological well-being and cognition. This research supports our long-term goal of designing and implementing intelligent interactive systems to improve the health of individuals with ADRD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 65 years

diagnosis of MCI (mild cognitive impairment) or mild ADRD

access to a reliable internet connection

community-dwelling

Disqualifiers

lives in an assisted living facility or nursing home

has moderate to severe ADRD as measured by the Quick Dementia Rating System

has a life expectancy of less than 6 months.

≥ 21 years old

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smart Virtual Reminiscence Therapy

    Device

    SVR Therapy is delivered through a computer program that can be accessed using a personal computer or smart device. It uses virtual reality, automated speech recognition, and large language models to achieve virtual therapist-patient interaction. The SVR therapy platform also automatically sources multi-modal reminiscence materials (e.g., images, text, etc.) through search engines and databases to facilitate the reminiscence therapy sessions. Each participant will participate in two 25-60 min (depending on content) sessions/week across 12 weeks. Each session will include multiple trials of reminiscence, such as music, sports, arts, etc. Each trial takes about 10 minutes to finish. The exact number of trials finished will depend on each patient's speed, preference, and how long they engage in the interaction with the SVR system. The participants can take breaks as needed.

  • Music Therapy

    Other intervention

    Participants in the attention control group will receive a curated playlist of calming music that they need to listen to twice a week for 12 weeks. The music can be conveniently accessed online (e.g., through YouTube).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Patient Music TherapyActive comparator 1 intervention
Group B: Smart Virtual Reminiscence TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score

Caregivers assess multiple (12) behavior domains for the patient. For each behavior that is present, behavior frequency and severity are rated. Frequency is rated on a 4 point scale, with 1 indicating rare behavior and 4 indicating very frequent behavior. Severity is rated on a 3 point scale, with 1 indicating mild behavior and 3 indicating severe behavior. The product of frequency multiplied by severity equals the total domain score for each behavior. Total domain scores are then summed to obtain the NPI total score. NPI total scores can range from 0 to 144, with higher scores indicating more frequent and severe behaviors overall.

Time frame
Baseline and Month 3
2

Rate of all-cause hospitalizations and emergency visits during the study period

These data will be collected and used to assess whether a reduction in BPSD may lead to fewer crisis events requiring acute medical care.

Time frame
Baseline through study completion, approximately 3 months

Secondary outcomes

Other outcomes

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