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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13weeks (baseline, post-intervention, follow up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13weeks (baseline, post-intervention, follow up)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver satisfaction of patient performance [Feasibility]
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
Secondary outcome measures
Functional Behavior Profile (FBP)
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Zarit Caregiver Burden Scale
Other outcome measures
Adult Sensory Profile (ASP)
Clinical Dementia Rating Scale (CDR-SUM)
Digital Biomarker of psychophysiological response to environment: electrodermal activity
+2 moreTrial 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.
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Who is running the clinical trial?
Elizabeth K RhodusLead Sponsor
3 Previous Clinical Trials
230 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,809 Total Patients Enrolled
Elizabeth Rhodus, PhDPrincipal InvestigatorUniversity of Kentucky
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65-99 with dementia, live at home, have a caregiver, and face behavioral challenges.I am a caregiver for someone with dementia, aged 21-99, speak English, and can handle mail.I am caring for someone with mild cognitive impairment or dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Harmony at HOME
- Group 2: National Institute on Aging Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals 30 years or older eligible for participation in this experiment?
"Per the requirements of this medical research, individuals must be at least 21 years old and not exceed 99 to qualify for participation."
Answered by AI
What qualifications must a person possess in order to join this clinical examination?
"This clinical trial is searching for 76 candidates with Alzheimer's disease, who are between 21 and 99 years old."
Answered by AI
Is there still availability for enrollment in this research study?
"According to clinicaltrials.gov, this trial is no longer recruiting participants for their studies, which were first posted on March 1st 2023 and last edited just a month later. Although the study has been closed off, there are currently 751 other trials actively looking for patients at this time."
Answered by AI
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