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

NCT05202223 | Completed Results

• 2 other identifiers: 66767P30AG064200
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Other Outcomes (4)

• Change in Caregiver Burden

  Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]

• Change in Caregiver Stress

  Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)]

• Change in Caregiver Satisfaction

  Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)

Study Arms (1)

Harmony at HOME

EXPERIMENTAL

H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.

Behavioral: Harmony at HOME (H@H)

Interventions

Harmony at HOME (H@H) BEHAVIORAL

H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.

Harmony at HOME

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caregiver for Participant with Dementia:
• Men or women aged 21-99, inclusive.
• Willingness and ability to participate in trial and implement recommended intervention strategies throughout the duration of the study.
• Access to and ability to use video technology (Zoom) for telehealth visits.
• English speaking, able to read and write.
• Ability to retrieve and return mail.
• Participants with Dementia:
• Men or women aged 65-99, inclusive.
• Living at home in the community with one primary caregiver.
• \. Diagnosis of Alzheimer's disease as primary dementia type of moderate to severe stages (confirmed by Clinical Dementia Rating Scale score of 1.0+)
• No change in medical condition for one month prior to screening visit
• No change in medications for 4 weeks prior to screening visit.
• If on psychotropic medication, the participant is at a point where dosage and treatment are stabilized for the duration of the study.
• Physically acceptable for this study as confirmed by medical history, physical exam, and clinical tests completed by medical professional (MD, APRN, PA or OT).
• Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)

You may not qualify if:

• Caregiver for Participant with Dementia:
• Diagnosis of mild cognitive impairment or dementia.
• Severe psychological stress or active state of psychiatric conditions (severe depression, mania, hallucinations/delusions).
• Participants with Dementia:
• Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
• Wheelchair or bed bound.
• Residence in skilled nursing facility or facility-based care.
• Skin lesions or skin abnormalities throughout upper extremities.
• Allergies related to lotion or fragrance.
• Caregiver report of physically violent behaviors.
• Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
• Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
• 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.
• Diagnosis or concern of epilepsy.
• Use of any investigational agents or devices within 30 days prior to screening.

Sponsors & Collaborators

• Elizabeth K Rhodus: lead
• National Institute on Aging (NIA): collaborator
• Emory University: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

• 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.

  PMID: 40621818 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Caregiver Burden; Behavior

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms

Results Point of Contact

• Title: Dr. Elizabeth Rhodus
• Organization: University of Kentucky

elizabeth.rhodus@uky.edu

859-257-5562

Study Officials

• Gregory Jicha, MD, PhD

  University of Kentucky

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: January 15, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 8, 2022
• Last Updated: December 29, 2023
• Results First Posted: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)