CompletedNot Applicable

Person-Environment Fit for Persons With Dementia

United States84 participantsStarted 2023-06-14

Plain-language summary

This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.

Who can participate

Age range

21 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Participants with Dementia * Men or women aged 60-99, inclusive. * Living at home in the community with one primary caregiver. * Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+) * If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study. * Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste) * Caregiver report of challenges related to behaviors within 4 weeks of study enrollment. * Caregiver willing to participate throughout duration of study. * Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment. Inclusion Criteria: Caregiver for Participants with Dementia * Men or women aged 21-99, inclusive. * Willingness to participate in study and implement recommended data collection tools. * English speaking, able to read and write. * Ability to retrieve and send mail. Exclusion Criteria: Participants with Dementia * Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc. * Wheelchair or bed bound. * Residence in skilled nursing facility or facility-based care. * Caregiver report of physically violent behaviors. * Initiation of antipsychotic medication within 4 weeks prior to scree…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)

Timeframe: 13weeks (baseline, post-intervention, follow up)

Caregiver satisfaction of patient performance [Feasibility]

Timeframe: 13 weeks (baseline, post intervention, follow up)

Trial details

NCT IDNCT05722743

SponsorElizabeth K Rhodus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-20

View on ClinicalTrials.gov More Dementia Alzheimers trials