Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers

• ClinicalTrials.gov Identifier: NCT05202223
• Recruitment Status: Completed
• First Posted: January 21, 2022
• Last Update Posted: January 26, 2023
• Sponsor: Allison Gibson
• Collaborators: National Institute on Aging (NIA); Emory University
• Information provided by (Responsible Party): Allison Gibson, University of Kentucky

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders	Behavioral: Harmony at HOME (H@H)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Creating Harmony at HOME: A Pilot Study of a Telehealth Based Program for Rural Caregivers' Ability to Adapt Home Environments for Adults With ADRD
• Actual Study Start Date: January 15, 2022
• Actual Primary Completion Date: December 8, 2022
• Actual Study Completion Date: December 8, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Harmony at HOME; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in caregiver mastery [ Time Frame: Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up) ]
   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 Outcome Measures:

1. Change in caregiver burden [ Time Frame: 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.
2. Change in caregiver stress [ Time Frame: 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.
3. Change in caregiver satisfaction [ Time Frame: 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.
4. Change in behavioral symptoms of person with Alzheimer's disease [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 UKADC or 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.

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky

Lexington, Kentucky, United States, 40506

Sponsors and Collaborators

Allison Gibson

National Institute on Aging (NIA)

Emory University

Investigators

• Study Director: Gregory Jicha, MD, PhD; University of Kentucky

  Study Documents (Full-Text)

Documents provided by Allison Gibson, University of Kentucky:

Informed Consent Form  [PDF] July 14, 2022

More Information

• Responsible Party: Allison Gibson, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05202223
• Other Study ID Numbers: 66767; P30AG064200 ( U.S. NIH Grant/Contract )
• First Posted: January 21, 2022
• Last Update Posted: January 26, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Allison Gibson, University of Kentucky:

Telehealth; Caregiver burnout; Behavioral and psychological symptoms of dementia; BPSD; Environment

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Nervous System Diseases; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Tauopathies; Disease; Mental Disorders; Neurocognitive Disorders; Pathologic Processes