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Environmental Design for Behavioral Regulation in People With Dementia

Primary Purpose

Alzheimer Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Environmental Design

Individual Environmental Design

Placebo

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring environment, Occupational therapy

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or women aged 21-90, 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
Stable medical condition for one month prior to screening visit
Stable medications for 4 weeks prior to screening visit
Caregiver report of challenges related to behaviors within 4 weeks of study enrollment
Caregiver willing to participant throughout duration of study

Exclusion Criteria:

Unstable medical conditions for 3 months prior to screening
Wheelchair or bed bound.
Residence in skilled nursing facility or facility-based care.
Skin lesions or skin abnormalities throughout upper extremities.

Sites / Locations

University of Kentcuky

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Standard Environmental Design

Individualized Environmental Design Protocol

Arm Description

Alzheimer's disease patients and caregivers.

Outcomes

Primary Outcome Measures

Success Rate of Adherence

Percentage of participants who had 75% adherence to the protocol based on visits and journals.

Secondary Outcome Measures

Change in Occupational Performance

Occupational performance will be measured using the Canadian Occupational Performance Measure (COPM) at baseline, post-intervention and the 4-week follow up. Scores range from 0-10; higher scores indicate (increased) occupational performance.

Change in Behavior

Behavior will be measured using the Neuropsychiatric Inventory (NPI-Q) at baseline, post-intervention and the 4-week follow up. Scores range from 1-36; higher scores indicate higher behavior severity.

Full Information

NCT ID

NCT04555616

First Posted

September 14, 2020

Last Updated

March 19, 2023

Sponsor

Elizabeth K Rhodus

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04555616

Brief Title

Environmental Design for Behavioral Regulation in People With Dementia

Official Title

Environmental Design for Behavioral Regulation in People With Dementia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

January 25, 2021 (Actual)

Primary Completion Date

October 13, 2021 (Actual)

Study Completion Date

October 13, 2021 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Individuals with dementia present with changes in behaviors throughout the continuum of cognitive decline. Environmental features may be influential in behavioral regulation. The purpose of this study is to assess the feasibility of environmental design protocols in older adults with dementia and their caregivers. Thirty subjects with moderate to severe Alzheimer's disease as primary dementia type, and their caregivers, will be randomly assigned to one of three arms: standard care; standard environmental design protocol; or personalized environmental design protocol.

6. Conditions and Keywords

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

Alzheimer Disease

Keywords

environment, Occupational therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Alzheimer's disease patients and caregivers.

Arm Title

Standard Environmental Design

Arm Type

Experimental

Arm Description

Alzheimer's disease patients and caregivers.

Arm Title

Individualized Environmental Design Protocol

Arm Type

Experimental

Arm Description

Alzheimer's disease patients and caregivers.

Intervention Type

Behavioral

Intervention Name(s)

Standard Environmental Design

Intervention Description

Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.

Intervention Type

Behavioral

Intervention Name(s)

Individual Environmental Design

Intervention Description

Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.

Intervention Type

Behavioral

Intervention Name(s)

Placebo

Intervention Description

Participants' caregivers will receive a set script of placebo modifications.

Primary Outcome Measure Information:

Title

Success Rate of Adherence

Description

Percentage of participants who had 75% adherence to the protocol based on visits and journals.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in Occupational Performance

Description

Time Frame

10 weeks (at baseline, 6 weeks and the 4 week follow up)

Title

Change in Behavior

Description

Time Frame

10 weeks (at baseline, 6 weeks and the 4 week follow up)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men or women aged 21-90, 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 Stable medical condition for one month prior to screening visit Stable medications for 4 weeks prior to screening visit Caregiver report of challenges related to behaviors within 4 weeks of study enrollment Caregiver willing to participant throughout duration of study Exclusion Criteria: Unstable medical conditions for 3 months prior to screening Wheelchair or bed bound. Residence in skilled nursing facility or facility-based care. Skin lesions or skin abnormalities throughout upper extremities.

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 Kentcuky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Environmental Design for Behavioral Regulation in People With Dementia

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