An interventional study of Harmony at HOME (H@H) in Alzheimer Disease, Dementia and Brain Diseases, sponsored by Elizabeth K Rhodus. Completed at 1 site in United States. Open to participants aged 21 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Elizabeth K Rhodus · Not applicable, Interventional, and Supportive care
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Elizabeth K Rhodus is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Behavioral: Harmony at HOME (H@H)
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
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.
Time frame: baseline, visit 2 (week 6), visit 3 (week 10)
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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]
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.
Time frame: 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.
Time frame: 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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)
| Milestone | Harmony at HOME |
|---|---|
| Started | 80 |
| Completed | 52 |
| Not completed | 28 |
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.
| units on a scale | Harmony at HOME |
|---|---|
| Baseline | 12.6 ± 2.1 |
| Visit 2 | 13 ± 1.6 |
| Visit 3 | 13 ± 1.7 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Revised Memory and Behavior Problems Checklist: 24-item caregiver report measure, 5-point Likert scale, higher scores mean greater behavioral problems.
Results for this outcome have not been posted.
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Harmony at HOME | 0/40 (0%) | 0/40 (0%) | 14/40 (35%) |
| Event | Harmony at HOME |
|---|---|
| FallGeneral disorders | 12/40 |
| HospitalizationGeneral disorders | 2/40 |
39 dyads completed baseline data collection (39 caregivers and 39 persons with cognitive impairment)
| Age, Continuous(years) | Harmony at HOME |
|---|---|
| Caregiver | 60.69 ± 1.99 |
| Participant with Dementia | 78.74 ± 1.09 |
| Sex: Female, Male(Participants) | Harmony at HOME |
|---|---|
| Caregiver — Female | 6 |
| Caregiver — Male | 33 |
| Participant with Dementia — Female | 11 |
| Participant with Dementia — Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Harmony at HOME |
|---|---|
| Caregiver — Hispanic or Latino | 0 |
| Caregiver — Not Hispanic or Latino | 37 |
| Caregiver — Unknown or Not Reported | 2 |
| Participant with Dementia — Hispanic or Latino | 0 |
| Participant with Dementia — Not Hispanic or Latino | 29 |
| Participant with Dementia — Unknown or Not Reported | 10 |
| Race (NIH/OMB)(Participants) | Harmony at HOME |
|---|---|
| Caregiver — American Indian or Alaska Native | 0 |
| Caregiver — Asian | 0 |
| Caregiver — Native Hawaiian or Other Pacific Islander | 0 |
| Caregiver — Black or African American | 1 |
| Caregiver — White | 35 |
| Caregiver — More than one race | 0 |
| Caregiver — Unknown or Not Reported | 3 |
| Participant with Dementia — American Indian or Alaska Native | 0 |
| Participant with Dementia — Asian | 0 |
| Participant with Dementia — Native Hawaiian or Other Pacific Islander | 0 |
| Participant with Dementia — Black or African American | 1 |
| Participant with Dementia — White | 30 |
| Participant with Dementia — More than one race | 0 |
| Participant with Dementia — Unknown or Not Reported | 8 |
| Region of Enrollment(participants) | Harmony at HOME |
|---|---|
| United States | 80 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2022 to primary completion in Nov 2022, 9 months.
Results were first posted in Dec 2023, 1 year 1 month after primary completion.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 9 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Elizabeth K Rhodus