Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
84 participants
INTERVENTIONAL
2023-06-14
2025-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers
NCT05202223
Environmental Design for Behavioral Regulation in People With Dementia
NCT04555616
Optimizing Care for Patients With Dementia
NCT03442322
Alzheimer's Disease Multiple Intervention Trial
NCT01314950
A Study of Caregiver Connections Via Technology in Dementia
NCT05779839
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Harmony at HOME
Participants in this group will receive the Harmony at HOME intervention.
Harmony at HOME
The Harmony at HOME (Help Online Modifying the Environment) intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment.
National Institute on Aging Program
Participants in this group will receive the National Institute on Aging education.
National Institute on Aging Program
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Harmony at HOME
The Harmony at HOME (Help Online Modifying the Environment) intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment.
National Institute on Aging Program
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
* 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 screening or unpredictable use of such medications
* Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
* Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
* Major infection within 4 weeks prior to the Baseline Visit.
• Diagnosis of mild cognitive impairment or dementia.
21 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Elizabeth K Rhodus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Elizabeth K Rhodus
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Rhodus, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kentucky
Lexington, Kentucky, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
72893
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.