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

Primary Purpose

Alzheimer Disease, Dementia, Brain Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harmony at HOME (H@H)
Sponsored by
Elizabeth K Rhodus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Telehealth, Caregiver burnout, Behavioral and psychological symptoms of dementia, BPSD, Environment

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Harmony at HOME

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 7, 2022
Last Updated
July 9, 2023
Sponsor
Elizabeth K Rhodus
Collaborators
National Institute on Aging (NIA), Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT05202223
Brief Title
Harmony at Home: A Pilot Telehealth Program for Rural ADRD Caregivers
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elizabeth K Rhodus
Collaborators
National Institute on Aging (NIA), Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Harmony at HOME
Arm Type
Experimental
Arm Description
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Intervention Type
Behavioral
Intervention Name(s)
Harmony at HOME (H@H)
Intervention Description
H@H is a 6-week telehealth intervention delivered by an occupational therapist during weekly visits.
Primary Outcome Measure Information:
Title
Change in caregiver mastery
Description
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
Timeframe 10 weeks (baseline, 6 weeks, 4 week follow up)
Other Pre-specified Outcome Measures:
Title
Change in caregiver burden
Description
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)]
Title
Change in caregiver stress
Description
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)]
Title
Change in caregiver satisfaction
Description
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)
Title
Change in behavioral symptoms of person with Alzheimer's disease
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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. 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+) 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) Caregiver report of challenges related to behaviors within 4 weeks of study enrollment. Caregiver willing to participant throughout duration of study. Caregiver access to and ability to use video technology (Zoom, Skype, video call) which resembles telehealth visits. Contact with UKADC or KNI medical provider within 12 months of study recruitment. Not actively participating in physical/occupational therapy throughout duration of study. Exclusion Criteria 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. Major infection within 4 weeks prior to the Baseline Visit. Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Jicha, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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