Dementia AlzheimersNCT05722743
Person-Environment Fit for Persons With Dementia
A study testing Harmony and National Institute on Aging Program in people with Dementia Alzheimers and Alzheimer Disease, run by Elizabeth K Rhodus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers, Alzheimer Disease
- What is being tested?
- Harmony and National Institute on Aging Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2023to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 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.
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- 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.
- Exclusion Criteria: Caregiver for Participant with Dementia:
- Diagnosis of mild cognitive impairment or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Person-Environment Fit of Community-Residing Older Adults With Dementia
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.
- Conditions
- Dementia Alzheimers, Alzheimer Disease
- Being tested
- Harmony, National Institute on Aging Program
- Keywords
- Behavioral, Occupational therapy, Alzheimer's disease and related dementias, Telehealth, Caregiver
- Medical subject headings
- Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HarmonyBehavioural
The Harmony 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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Harmony | Experimental | Participants in this group will receive the Harmony intervention. Receives: Behavioral: Harmony |
| National Institute on Aging Program | Active comparator | Participants in this group will receive the National Institute on Aging education. Receives: Behavioral: National Institute on Aging Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Performance as Measured by Canadian Occupational Performance Measure (COPM)
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
Measured: Baseline to 13 Week Follow-Up
Caregiver Satisfaction of Patient Performance [Feasibility]
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
Measured: Baseline to 13 Week Follow-Up
Secondary outcomes (3)
Zarit Caregiver Burden Scale
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden.
Measured: Baseline to 13 Week Follow-Up
Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36
Measured: Baseline to 13 Week Follow-Up
Functional Behavior Profile (FBP)
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. The FBP consists of 27 items rated from 0 to 4, with higher scores indicating better performance. The total score ranges from 0 to 108. The FBP includes three subscales: Task Performance (0-36), Social Interaction (0-24) and Problem Solving (0-48). Subscale scores are summed to calculate the total FBP score.
Measured: Baseline to 13 Week Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start14 Jun 2023
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dementia AlzheimersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth K Rhodus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Elizabeth K Rhodus, University of Kentucky
- Investigators
- Elizabeth Rhodus, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722743
- Sponsor's protocol ID
- 72893
- Other IDs
- 1K23AG075262-01A1
- Status last verified
- Oct 2026
- First submitted
- 27 Dec 2022
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Person-Environment Fit of Community-Residing Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT05722743
- Acronym / sponsor ID
- 72893
- Conditions
- Dementia Alzheimers, Alzheimer Disease
- Keywords
- Behavioral, Occupational therapy, Alzheimer's disease and related dementias, Telehealth, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Elizabeth K RhodusUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmony | Experimental | Behavioral: HarmonyParticipants in this group will receive the Harmony intervention. |
| National Institute on Aging Program | Active comparator | Behavioral: National Institute on Aging ProgramParticipants in this group will receive the National Institute on Aging education. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (10 listed)
- 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 screening or unpredictable use of such medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HarmonyThe Harmony 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. | Behavioural | Harmony |
| National Institute on Aging ProgramStandard 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. | Behavioural | National Institute on Aging Program |
Primary outcome
Change in Patient Performance as Measured by Canadian Occupational Performance Measure (COPM)
Time frame: Baseline to 13 Week Follow-Up
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
Caregiver Satisfaction of Patient Performance [Feasibility]
Time frame: Baseline to 13 Week Follow-Up
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
3 secondary outcomes
Zarit Caregiver Burden Scale
Time frame: Baseline to 13 Week Follow-Up
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: Baseline to 13 Week Follow-Up
Functional Behavior Profile (FBP)
Time frame: Baseline to 13 Week Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Rhodus, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harmony and National Institute on Aging Program in people with Dementia Alzheimers and Alzheimer Disease, run by Elizabeth K Rhodus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Performance as Measured by Canadian Occupational Performance Measure (COPM) (time frame: Baseline to 13 Week Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.