Sidney & Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Location contact
Katrina Coppedge
CONTACT
Malaz Boustani, MD,MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07499570
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Katrina Coppedge
CONTACT
Malaz Boustani, MD,MPH
PRINCIPAL_INVESTIGATOR
Nonpharmacological approaches, such as Reminiscence Therapy (RT), have been a major investigation for ADRD in recent years, but lack of human facilitators, lack of training, technology adaptation, and lack of multi-sensory features are major implementation barriers. In addition, a good RT requires utilizing the personal life experiences of patients as topics of sharing, while showing concrete objects such as photographs, videos, and music that are memorable to the individuals. However, older adults may have a hard time collecting these materials for themselves.
To address these limitations, the researchers have developed a novel SVR that is delivered through a computer program that can be accessed using a personal computer or smart device, and includes new functions so that there is no need for a human therapist to facilitate the RT sessions, and so that older adults and care partners do not need to collect reminiscence materials in advance. SVR presents a virtual therapist (avatar) who interacts with older adults through verbal (speech) and non-verbal communication (eye gaze, body language, etc.), understands the user's speech, and guides the user through reminiscence sessions.
In this study, patient/caregiver dyads will be randomized to receive SVR intervention or an attention control intervention (listening to music). Participants randomized to SVR will either visit the study site (accompanied by the caregiver) to complete SVR sessions or complete the sessions at home, up to twice a week for 12 weeks. Participants randomized to the control arm will receive a curated playlist of calming music, accessible online, that they need to listen to twice a week for 12 weeks. Patient BPSD will be collected at baseline and monthly for 3 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For the patient:
Inclusion criteria
Exclusion criteria
For the care partner:
Inclusion criteria
Exclusion criteria
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.
Other names: SVR Therapy
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).
Time frame: Baseline and Month 3
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 through study completion, approximately 3 months
These data will be collected and used to assess whether a reduction in BPSD may lead to fewer crisis events requiring acute medical care.
Contact information is provided by the study sponsor or research team.
Indiana University
Other
Acronym: SVR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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