We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05202223
Recruitment Status : Completed
First Posted : January 21, 2022
Last Update Posted : January 26, 2023
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Emory University
Information provided by (Responsible Party):
Allison Gibson, University of Kentucky

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05202223


Locations
Layout table for location information
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Allison Gibson
National Institute on Aging (NIA)
Emory University
Investigators
Layout table for investigator information
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

Layout table for additonal 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    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Tauopathies
Disease
Mental Disorders
Neurocognitive Disorders
Pathologic Processes