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Person-Environment Fit for Persons With Dementia

Primary Purpose

Dementia Alzheimers, Alzheimer Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Harmony at HOME
National Institute on Aging Program
Sponsored by
Elizabeth K Rhodus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia Alzheimers focused on measuring Behavioral, Occupational therapy, Alzheimer's disease and related dementias, Telehealth, Caregiver

Eligibility Criteria

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

Inclusion Criteria: Participants with Dementia Men or women aged 65-99, inclusive. Living at home in the community with one primary caregiver. Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+) If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study. 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 participate throughout duration of study. Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment. Inclusion Criteria: Caregiver for Participants with Dementia Men or women aged 21-99, inclusive. Willingness to participate in study and implement recommended data collection tools. English speaking, able to read and write. Ability to retrieve and send mail. Exclusion Criteria: 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. 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. Major infection within 4 weeks prior to the Baseline Visit. Exclusion Criteria: Caregiver for Participant with Dementia: • Diagnosis of mild cognitive impairment or dementia.

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Harmony at HOME

National Institute on Aging Program

Arm Description

Participants in this group will receive the Harmony at HOME intervention.

Participants in this group will receive the National Institute on Aging education.

Outcomes

Primary Outcome Measures

Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
Caregiver satisfaction of patient performance [Feasibility]
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.

Secondary Outcome Measures

Zarit Caregiver Burden Scale
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden.
Neuropsychiatric Inventory Questionnaire (NPI-Q)
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36
Functional Behavior Profile (FBP)
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. Item responses range from 0 to 4, with higher scores indicating better performance (maximum score 108).

Full Information

First Posted
December 27, 2022
Last Updated
August 21, 2023
Sponsor
Elizabeth K Rhodus
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05722743
Brief Title
Person-Environment Fit for Persons With Dementia
Official Title
Improving Person-Environment Fit of Community-Residing Older Adults With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
June 15, 2026 (Anticipated)

3. Sponsor/Collaborators

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

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
This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance. Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers, Alzheimer Disease
Keywords
Behavioral, Occupational therapy, Alzheimer's disease and related dementias, Telehealth, Caregiver

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Harmony at HOME
Arm Type
Experimental
Arm Description
Participants in this group will receive the Harmony at HOME intervention.
Arm Title
National Institute on Aging Program
Arm Type
Active Comparator
Arm Description
Participants in this group will receive the National Institute on Aging education.
Intervention Type
Behavioral
Intervention Name(s)
Harmony at HOME
Intervention Description
The Harmony at HOME (Help Online Modifying the Environment) intervention builds on prior successful foundations of dementia care interventions with a novel approach combining remote implementation, antecedent education, and home environment intervention. The intervention will teach caregivers how to 1) assess the home environment as an antecedent to behavior for the person with ADRD, and 2) design and implement individualized environmental modification through an environmental cueing approach to address the needs of the person with ADRD in a supportive environment.
Intervention Type
Behavioral
Intervention Name(s)
National Institute on Aging Program
Intervention Description
Standard of care will address behaviors and psychiatric symptoms of dementia (BPSD) for persons with ADRD, as recommended by their medical provider. Caregivers will receive training regarding home safety via a home safety handout based on National Institutes on Aging "Home Safety and Alzheimer's Disease" webpage.
Primary Outcome Measure Information:
Title
Change in patient performance as measured by Canadian Occupational Performance Measure (COPM)
Description
Criterion-referenced interview of patient performance with caregiver The COPM is a reliable and validated measure of performance in primary daily activities (self-care, leisure, productivity) with dyad-caregiver rated of performance and satisfaction. Scores are determined on a likert scale of 1-10 with 1 being lowest and 10 indicating highest of the topic of the question.
Time Frame
13weeks (baseline, post-intervention, follow up)
Title
Caregiver satisfaction of patient performance [Feasibility]
Description
The primary outcome analysis is the feasibility of implementation as measured by caregiver satisfaction. The Canadian Occupational Performance Measure will measure caregiver satisfaction of patient performance, high scores indicate higher levels of satisfaction. Range 0-10.
Time Frame
13 weeks (baseline, post intervention, follow up)
Secondary Outcome Measure Information:
Title
Zarit Caregiver Burden Scale
Description
22-item survey, caregiver rates self-perceived level of burden on 5-point Likert scale. The social context of the person with ADRD will be described through analysis of caregiver demographics and rate of caregiver burden measured. Higher scores indicate greater burden. Range of 0-88 points. A score of 17 or more was considered high burden.
Time Frame
13 weeks (baseline, post intervention, follow up)
Title
Neuropsychiatric Inventory Questionnaire (NPI-Q)
Description
The NPI-Q is commonly used as an assessment of behavioral and psychiatric symptoms of dementia in older adults diagnosed with mild cognitive impairment or dementia, internationally, with high reliability and validity. Assessment includes 12 behavioral and psychiatric domains which are rated by caregiver as present or absent (yes/no). Caregivers further rate severity of present behavioral domains. The severity score is summed to yield a total as a measure of BPSD burden. Higher scores indicate higher levels of behavior symptom severity and/or distress. Range 0-36
Time Frame
13 weeks (baseline, post intervention, follow up)
Title
Functional Behavior Profile (FBP)
Description
Criterion-referenced survey completed by caregiver. The FBP has been established as a reliable and valid measure of task performance, social interaction, and problem solving with adults with ADRD. Item responses range from 0 to 4, with higher scores indicating better performance (maximum score 108).
Time Frame
13 weeks (baseline, post intervention, follow up)
Other Pre-specified Outcome Measures:
Title
Home Occupational Environment Assessment (HOEA)
Description
35-item survey completed by caregiver regarding home environment. Allows the caregiver to systematically assess the home environment including accessibility, sanitation, food storage, safety, and sensorial stimulation. Scores range 0-105 with higher scores indicating worse outcomes.
Time Frame
1 time (baseline)
Title
Adult Sensory Profile (ASP)
Description
Norm-referenced, 60-item survey completed by caregiver. The caregiver will complete the Adult Sensory Profile as proxy for person with ADRD. This is a valid and reliable 60-question assessment to determine sensory simulation preference and neurological ability for processing sensory simulation. This assessment is not based on a range of scores but normative values. Results can be more than or less than normative values.
Time Frame
1 time (baseline)
Title
Clinical Dementia Rating Scale (CDR-SUM)
Description
The Clinical Dementia Rating (CDR) sum of boxes, a valid and reliable measure, will determine severity of cognitive impairment. Six cognitive domains are assessed in CDR (memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care) with feedback from patient performance and caregiver result, and results are scored by a trained professional. Range 0-18, higher scores indicate higher levels of cognitive impairment.
Time Frame
1 time (baseline)
Title
Digital Biomarker of psychophysiological response to environment: heart rate variability
Description
Empatica wearable wrist device Assessment of stress-related biomarkers will measure heart rate variability in beats per minute.
Time Frame
Device worn by patient for 7 consecutive days
Title
Digital Biomarker of psychophysiological response to environment: electrodermal activity
Description
Empatica wearable wrist device Assessment of stress-related biomarkers will measure electrical conductance at the surface of the skin. Skin conductance is measured in units of microsiemens, with normal human EDA ranging from 1 to 20 microsiemens.
Time Frame
Device worn by patient for 7 consecutive days

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 Criteria: Participants with Dementia Men or women aged 65-99, inclusive. Living at home in the community with one primary caregiver. Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+) If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study. 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 participate throughout duration of study. Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment. Inclusion Criteria: Caregiver for Participants with Dementia Men or women aged 21-99, inclusive. Willingness to participate in study and implement recommended data collection tools. English speaking, able to read and write. Ability to retrieve and send mail. Exclusion Criteria: 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. 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. Major infection within 4 weeks prior to the Baseline Visit. Exclusion Criteria: Caregiver for Participant with Dementia: • Diagnosis of mild cognitive impairment or dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Rhodus, PhD
Phone
8592575562
Email
elizabeth.rhodus@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Celeste Roberts, MS
Phone
859-218-4851
Email
celeste.roberts@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rhodus, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Rhodus, PhD
Phone
859-257-5562
Email
elizabeth.rhodus@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Person-Environment Fit for Persons With Dementia

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