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Completed

NCT Number: NCT04555616

Environmental Design for Behavioral Regulation in People With Dementia

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.

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Key information

Conditions

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

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentcuky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Environmental Design

Behavioral

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.

Individual Environmental Design

Behavioral

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.

Placebo

Behavioral

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

Primary outcomes

  1. Success Rate of Adherence

    Time frame: 6 weeks

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

Secondary outcomes

  1. Change in Occupational Performance

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

    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.

  2. Change in Behavior

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

    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.

Sponsors and collaborators

Lead sponsor

Elizabeth K Rhodus

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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