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Non-pharmacological Intervention

Telehealth Intervention for Dementia

N/A
Recruiting
Led By Elizabeth Rhodus, PhD
Research Sponsored by Elizabeth K Rhodus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13weeks (baseline, post-intervention, follow up)
Awards & highlights

Summary

This trial will test if a telehealth intervention can help improve the symptoms of dementia and functional performance in those living with Alzheimer's and related dementias.

Who is the study for?
This trial is for pairs of individuals where one person has dementia (aged 65-99, living at home with a caregiver, and experiencing behavioral challenges) and the other is their caregiver (aged 21-99). Caregivers must be able to communicate in English and handle mail. People can't join if they have severe cognitive impairments themselves or are caring for someone who's very physically ill or violent.
What is being tested?
The study tests an 8-week telehealth occupational therapy program called Harmony at HOME against a control group receiving general caregiver education via Zoom. It aims to see if this intervention helps reduce dementia symptoms and improve daily function.
What are the potential side effects?
Since the interventions involve non-pharmacological methods like occupational therapy sessions and educational discussions, there are no direct medical side effects. However, participants may experience stress or fatigue from regular Zoom sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13weeks (baseline, post-intervention, follow up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13weeks (baseline, post-intervention, follow up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver satisfaction of patient performance [Feasibility]
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
Secondary study objectives
Functional Behavior Profile (FBP)
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Zarit Caregiver Burden Scale
Other study objectives
Adult Sensory Profile (ASP)
Clinical Dementia Rating Scale (CDR-SUM)
Digital Biomarker of psychophysiological response to environment: electrodermal activity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Harmony at HOMEExperimental Treatment1 Intervention
Participants in this group will receive the Harmony at HOME intervention.
Group II: National Institute on Aging ProgramActive Control1 Intervention
Participants in this group will receive the National Institute on Aging education.

Find a Location

Who is running the clinical trial?

Elizabeth K RhodusLead Sponsor
3 Previous Clinical Trials
110 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,927 Total Patients Enrolled
Elizabeth Rhodus, PhDPrincipal InvestigatorUniversity of Kentucky

Media Library

Harmony at HOME (Non-pharmacological Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05722743 — N/A
Alzheimer's Dementia Research Study Groups: Harmony at HOME, National Institute on Aging Program
Alzheimer's Dementia Clinical Trial 2023: Harmony at HOME Highlights & Side Effects. Trial Name: NCT05722743 — N/A
Harmony at HOME (Non-pharmacological Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722743 — N/A
~32 spots leftby Aug 2025
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