Alzheimer DiseaseNCT04555616
Environmental Design for Behavioral Regulation in People With Dementia
A study testing Standard Environmental Design and Individual Environmental Design in people with Alzheimer Disease, run by Elizabeth K Rhodus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Standard Environmental Design and Individual Environmental Design
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 13 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Standard Environmental Design, Individual Environmental Design, Placebo
- Keywords
- environment, Occupational therapy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Environmental DesignBehavioural
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 DesignBehavioural
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.
PlaceboBehavioural
Participants' caregivers will receive a set script of placebo modifications.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Alzheimer's disease patients and caregivers. Receives: Behavioral: Placebo |
| Standard Environmental Design | Experimental | Alzheimer's disease patients and caregivers. Receives: Behavioral: Standard Environmental Design |
| Individualized Environmental Design Protocol | Experimental | Alzheimer's disease patients and caregivers. Receives: Behavioral: Individual Environmental Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Adherence
Percentage of participants who had 75% adherence to the protocol based on visits and journals.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
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.
Measured: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start25 Jan 2021
- Primary completion13 Oct 2021
- Study completion13 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth K Rhodus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Elizabeth K Rhodus, University of Kentucky
- Investigators
- Gregory Jicha, MD-PhD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555616
- Sponsor's protocol ID
- 61291
- Other IDs
- T32AG057461
- Status last verified
- Mar 2023
- First submitted
- 14 Sep 2020
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Design for Behavioral Regulation in People With Dementia
- ClinicalTrials.gov ID
- NCT04555616
- Acronym / sponsor ID
- 61291
- Conditions
- Alzheimer Disease
- Keywords
- environment, Occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Elizabeth K RhodusUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 13 Oct 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: PlaceboAlzheimer's disease patients and caregivers. |
| Standard Environmental Design | Experimental | Behavioral: Standard Environmental DesignAlzheimer's disease patients and caregivers. |
| Individualized Environmental Design Protocol | Experimental | Behavioral: Individual Environmental DesignAlzheimer's disease patients and caregivers. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Environmental DesignParticipants' 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. | Behavioural | Standard Environmental Design |
| Individual Environmental DesignParticipants' 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. | Behavioural | Individualized Environmental Design Protocol |
| PlaceboParticipants' caregivers will receive a set script of placebo modifications. | Behavioural | Control Group |
Primary outcome
Success Rate of Adherence
Time frame: 6 weeks
Percentage of participants who had 75% adherence to the protocol based on visits and journals.
2 secondary outcomes
Change in Occupational Performance
Time frame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
Change in Behavior
Time frame: 10 weeks (at baseline, 6 weeks and the 4 week follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Jicha, MD-PhD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Environmental Design and Individual Environmental Design in people with Alzheimer Disease, run by Elizabeth K Rhodus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Adherence (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.