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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AG075262-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmony at HOME | Experimental | Participants in this group will receive the Harmony at HOME intervention. |
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| National Institute on Aging Program | Active Comparator | Participants in this group will receive the National Institute on Aging education. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmony at HOME | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13weeks (baseline, post-intervention, 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. | 13 weeks (baseline, post intervention, follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 weeks (baseline, post intervention, follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Home Occupational Environment Assessment (HOEA) | 35-item survey completed by caregiver regarding home environment. Allows the caregiver to systematically assess the home environment including accessibility, sanitation, food storage, safety, and sensorial stimulation. Scores range 0-105 with higher scores indicating worse outcomes. | 1 time (baseline) |
Inclusion Criteria: Participants with Dementia
Inclusion Criteria: Caregiver for Participants with Dementia
Exclusion Criteria: Participants with Dementia
Exclusion Criteria: Caregiver for Participant with Dementia:
• Diagnosis of mild cognitive impairment or dementia.
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Rhodus, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2024 | Oct 13, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| National Institute on Aging Program | Behavioral | 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. |
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| 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 | 13 weeks (baseline, post intervention, 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. Item responses range from 0 to 4, with higher scores indicating better performance (maximum score 108). | 13 weeks (baseline, post intervention, follow up) |
| Adult Sensory Profile (ASP) | Norm-referenced, 60-item survey completed by caregiver. The caregiver will complete the Adult Sensory Profile as proxy for person with ADRD. This is a valid and reliable 60-question assessment to determine sensory simulation preference and neurological ability for processing sensory simulation. This assessment is not based on a range of scores but normative values. Results can be more than or less than normative values. | 1 time (baseline) |
| Clinical Dementia Rating Scale (CDR-SUM) | The Clinical Dementia Rating (CDR) sum of boxes, a valid and reliable measure, will determine severity of cognitive impairment. Six cognitive domains are assessed in CDR (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) with feedback from patient performance and caregiver result, and results are scored by a trained professional. Range 0-18, higher scores indicate higher levels of cognitive impairment. | 1 time (baseline) |
| Digital Biomarker of psychophysiological response to environment: heart rate variability | Empatica wearable wrist device Assessment of stress-related biomarkers will measure heart rate variability in beats per minute. | Device worn by patient for 7 consecutive days |
| Digital Biomarker of psychophysiological response to environment: electrodermal activity | Empatica wearable wrist device Assessment of stress-related biomarkers will measure electrical conductance at the surface of the skin. Skin conductance is measured in units of microsiemens, with normal human EDA ranging from 1 to 20 microsiemens. | Device worn by patient for 7 consecutive days |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |