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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Emory University | OTHER |
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There is a need for caregiver-initiated and -implemented non-pharmacological interventions directly to and for the person with dementia, including environmental assessment and modification, as first-line treatments for behavioral and psychological symptoms of dementia (BPSD) in persons living with dementia (PLWD). Delivered via telehealth, Harmony at HOME (H@H) aims to train caregivers of persons with moderate to severe ADRD in the skills of assessing and modifying the home environment to promote "person-environment fit," a concept that posits that the ability to access features within a built environment (e.g. bathroom, stairs,) or that factors within the environment itself (lighting, noise level, temperature), especially when linked with individualized social support, contribute to or even shape behavior.
In addition to the intervention, the first 10 caregiver participants to enroll will also be invited to participate in two focus groups that will be facilitated during and after the intervention. The first focus group focuses on experiences as a dementia caregiver in rural areas. The second focus group focuses on providing feedback regarding caregivers' perceptions, acceptability, and usefulness of the H@H intervention. These focus groups will be conducted as structured interviews with open-ended questions that encourage participants to share their experiences.
Behavioral disruptions by individuals with Alzheimer's disease and related dementias (ADRD) are reported in nearly 90% of persons living with ADRD. Such behavioral and psychological symptoms of dementia (BPSD) are highly correlated with increased caregiver burden and burnout, decreased quality of life for the person living with dementia and their caregiver, institutionalization, and patient mortality. There is a need for caregiver-initiated and -implemented non-pharmacological interventions directly to and for the person with dementia, including environmental assessment and modification, as first-line treatments for BPSD in persons living with dementia (PLWD). Delivered via telehealth, Harmony at HOME (H@H) aims to train caregivers of persons with moderate to severe ADRD in the skills of assessing and modifying the home environment to promote "person-environment fit," a concept that posits that the ability to access features within a built environment (e.g. bathroom, stairs,) or that factors within the environment itself (lighting, noise level, temperature), especially when linked with individualized social support, contribute to or even shape behavior. In ideal circumstances, adults adjust or adapt to meet the demands of the environment; likewise, in the ideal, environments are designed in ways that facilitate positive behaviors. ADRD progressively interferes with an individual's capacity to self-optimize person-environment fit; in such cases, caregivers have the opportunity to create a supportive environment that negates some behavioral challenges and encourages functional activity engagement. H@H seeks to help caregivers acquire the skills and sense of mastery that will enable them to create such supportive environments within the homes of people with dementia. H@H will be tested with caregivers and the person living with dementia in the Appalachian region of rural Kentucky, a region with the poorest healthcare options for older adults in the country and plagued with extremely high rates of co-morbid conditions, including ADRD. Access to quality caregiver training, in-home caregiver support, and respite is significantly limited. This pilot study will enable the investigators not only to establish the feasibility of the program but to demonstrate this capacity with a population of caregivers and persons with dementia that is in particular need and difficult to reach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmony at HOME | Experimental | H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmony at HOME (H@H) | Behavioral | H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Mastery | Pearlin Mastery Scale: A 4-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 4 to 16, with higher scores indicating greater levels of mastery. | baseline, visit 2 (week 6), visit 3 (week 10) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver Burden | Zarit Burden Interview: It is a questionnaire consisting of 22 items. A minimum score of 0 and a maximum score of 88 can be obtained. The higher the scale score, the higher the difficulty experienced. | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] |
| Change in Caregiver Stress |
Inclusion and excluded groups: Recruitment and enrollment will be inclusive of all groups living within rural, Appalachia Kentucky who are over the age of 21.
Participants must meet all inclusion criteria in order to participate in the study:
Caregiver for Participant with Dementia:
Participants with Dementia:
Exclusion Criteria
Caregiver for Participant with Dementia:
Participants with Dementia:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Jicha, MD, PhD | University of Kentucky | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40621818 | Derived | Rhodus EK, Kryscio R, Jicha G, Baum C, Henley L, Fairchild V, Roberts C, Gibson A. Creating harmony at home via environmental cueing: A feasibility trial of a non-pharmacological intervention for rural caregivers of persons with dementia. Alzheimers Dement. 2025 Jul;21(7):e70405. doi: 10.1002/alz.70405. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Harmony at HOME | H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. Harmony at HOME (H@H): H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2023 |
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Perceived Stress Scale: Caregiver report of perceived stress. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome. |
| Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] |
| Change in Caregiver Satisfaction | Revised Caregiving Appraisal Scale, Sub-scale on caregiver satisfaction: Care partner satisfaction consisting of 6-items, 5-point Likert scale. Higher score indicates greater satisfaction. | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) |
| Change in Behavioral Symptoms of Person With Alzheimer's Disease | Revised Memory and Behavior Problems Checklist: 24-item caregiver report measure, 5-point Likert scale, higher scores mean greater behavioral problems. | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) |
| COMPLETED |
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| NOT COMPLETED |
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39 dyads completed baseline data collection (39 caregivers and 39 persons with cognitive impairment)
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| ID | Title | Description |
|---|---|---|
| BG000 | Harmony at HOME | H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. Harmony at HOME (H@H): H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Only 78 participants completed baseline data collection | Mean | Standard Deviation | years |
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| Sex: Female, Male | There was no response to this question for 8 participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 78 completed baseline data collection | Count of Participants | Participants |
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| Race (NIH/OMB) | 78 participants completed baseline data collection. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Caregiver Mastery | Pearlin Mastery Scale: A 4-item scale measuring the extent to which a participant sees life as being under his/her personal control vs. something that is fatalistically ruled. Scores range from 4 to 16, with higher scores indicating greater levels of mastery. | Only caregiver data are reported for this outcome. 1 participant was unable to be contacted for visit 3 data collection | Posted | Mean | Standard Deviation | units on a scale | baseline, visit 2 (week 6), visit 3 (week 10) |
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| Other Pre-specified | Change in Caregiver Burden | Zarit Burden Interview: It is a questionnaire consisting of 22 items. A minimum score of 0 and a maximum score of 88 can be obtained. The higher the scale score, the higher the difficulty experienced. | Not Posted | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] | Participants | |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Caregiver Stress | Perceived Stress Scale: Caregiver report of perceived stress. The minimum total score possible is 0 and the maximum total score possible is 40. Higher values represent a worse outcome. | Not Posted | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] | Participants | |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Caregiver Satisfaction | Revised Caregiving Appraisal Scale, Sub-scale on caregiver satisfaction: Care partner satisfaction consisting of 6-items, 5-point Likert scale. Higher score indicates greater satisfaction. | Not Posted | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) | Participants | |||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Behavioral Symptoms of Person With Alzheimer's Disease | Revised Memory and Behavior Problems Checklist: 24-item caregiver report measure, 5-point Likert scale, higher scores mean greater behavioral problems. | Not Posted | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) | Participants |
10 weeks
All-Cause Mortality, Serious Adverse Events and Other Adverse Events were reported for participants with dementia. All-Cause Mortality, Serious Adverse Events and Other Adverse Events were not monitored/assessed in caregiver participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Harmony at HOME | This is a single-arm study. Dyads (caregiver and person with dementia) were enrolled in the H@H telehealth intervention delivered by an occupational therapist during weekly visits. Participants were either 1) caregiver or 2) person with dementia (person at risk). Adverse Events are reported for persons with dementia. | 0 | 40 | 0 | 40 | 14 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment | All AE reported were of the person with dementia (the person at risk). |
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| Hospitalization | General disorders | Non-systematic Assessment | All AE reported were of the person with dementia (the person at risk). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Rhodus | University of Kentucky | 859-257-5562 | elizabeth.rhodus@uky.edu |
| Oct 30, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2022 | Jan 24, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000084802 | Caregiver Burden |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
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| Male |
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| Participant with Dementia |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Participant with Dementia |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participant with Dementia |
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| Visit 3 |
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