Alzheimer Disease, Brain Diseases, Central Nervous System Diseases, Dementia, Mental Disorders, Nervous System Diseases, Neurocognitive Disorders, Neurodegenerative Diseases, Tauopathies
Conditions
Keywords
Telehealth, Caregiver burnout, Behavioral and psychological symptoms of dementia, BPSD, Environment
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHarmony at HOME (H@H)
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Sponsors
National Institute on Aging (NIA)
Emory University
Elizabeth K Rhodus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
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: 1. Men or women aged 21-99, inclusive. 2. Willingness and ability to participate in trial and implement recommended intervention strategies throughout the duration of the study. 3. Access to and ability to use video technology (Zoom) for telehealth visits. 4. English speaking, able to read and write. 5. Ability to retrieve and return mail. Participants with Dementia: 1. Men or women aged 65-99, inclusive. 2. Living at home in the community with one primary caregiver. 3. 3\. Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages (confirmed by Clinical Dementia Rating Scale score of 1.0+) 4. No change in medical condition for one month prior to screening visit 5. No change in medications for 4 weeks prior to screening visit. 6. If on psychotropic medication, the participant is at a point where dosage and treatment are stabilized for the duration of the study. 7. Physically acceptable for this study as confirmed by medical history, physical exam, and clinical tests completed by medical professional (MD, APRN, PA or OT). 8. Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste) 9. Caregiver report of challenges related to behaviors within 4 weeks of study enrollment. 10. Caregiver willing to participant throughout duration of study. 11. Caregiver access to and ability to use video technology (Zoom, Skype, video call) which resembles telehealth visits. 12. Contact with University of Kentucky Alzheimer's Disease Center (UKADC) or Kentucky Neuroscience Institute (KNI) medical provider within 12 months of study recruitment. 13. Not actively participating in physical/occupational therapy throughout duration of study.
Exclusion criteria
Caregiver for Participant with Dementia: 1. Diagnosis of mild cognitive impairment or dementia. 2. Severe psychological stress or active state of psychiatric conditions (severe depression, mania, hallucinations/delusions). Participants with Dementia: 1. Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc. 2. Wheelchair or bed bound. 3. Residence in skilled nursing facility or facility-based care. 4. Skin lesions or skin abnormalities throughout upper extremities. 5. Allergies related to lotion or fragrance. 6. Caregiver report of physically violent behaviors. 7. Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications 8. Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia. 9. 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. 10. Diagnosis or concern of epilepsy. 11. Use of any investigational agents or devices within 30 days prior to screening. 12. Major infection within 4 weeks prior to the Baseline Visit. 13. Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Mastery | baseline, visit 2 (week 6), visit 3 (week 10) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] | 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. |
| Change in Caregiver Stress | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)] | 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. |
| Change in Caregiver Satisfaction | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) | 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. |
| Change in Behavioral Symptoms of Person With Alzheimer's Disease | Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) | Revised Memory and Behavior Problems Checklist: 24-item caregiver report measure, 5-point Likert scale, higher scores mean greater behavioral problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Total | 78 |
Baseline characteristics
| Characteristic | Harmony at HOME |
|---|---|
| Age, Continuous Caregiver | 60.69 years STANDARD_DEVIATION 1.99 |
| Age, Continuous Participant with Dementia | 78.74 years STANDARD_DEVIATION 1.09 |
| Ethnicity (NIH/OMB) Caregiver Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Caregiver Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Caregiver Unknown or Not Reported | 2 Participants |
| Ethnicity (NIH/OMB) Participant with Dementia Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Participant with Dementia Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Participant with Dementia Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) Caregiver American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregiver Asian | 0 Participants |
| Race (NIH/OMB) Caregiver Black or African American | 1 Participants |
| Race (NIH/OMB) Caregiver More than one race | 0 Participants |
| Race (NIH/OMB) Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregiver Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) Caregiver White | 35 Participants |
| Race (NIH/OMB) Participant with Dementia American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Participant with Dementia Asian | 0 Participants |
| Race (NIH/OMB) Participant with Dementia Black or African American | 1 Participants |
| Race (NIH/OMB) Participant with Dementia More than one race | 0 Participants |
| Race (NIH/OMB) Participant with Dementia Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Participant with Dementia Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) Participant with Dementia White | 30 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Caregiver Female | 6 Participants |
| Sex: Female, Male Caregiver Male | 33 Participants |
| Sex: Female, Male Participant with Dementia Female | 11 Participants |
| Sex: Female, Male Participant with Dementia Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 14 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: baseline, visit 2 (week 6), visit 3 (week 10)
Population: Only caregiver data are reported for this outcome. 1 participant was unable to be contacted for visit 3 data collection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Harmony at HOME | Change in Caregiver Mastery | Visit 3 | 13 units on a scale | Standard Deviation 1.7 |
| Harmony at HOME | Change in Caregiver Mastery | Baseline | 12.6 units on a scale | Standard Deviation 2.1 |
| Harmony at HOME | Change in Caregiver Mastery | Visit 2 | 13 units on a scale | Standard Deviation 1.6 |
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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)
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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]
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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)
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.
Time frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]