N/A
N=30
Environmental Design for Behavioral Regulation in People With Dementia
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT04555616 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Success Rate of Adherence — 2; 6; 7 Participants — p=0.12
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Environmental Design (Behavioral); Individual Environmental Design (Behavioral); Placebo (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Elizabeth K Rhodus
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate of Adherence |
2; 6; 7 | 0.12 |
| SECONDARY Change in Occupational Performance |
4.6; 3.6; 4.4; 4.6; 6.1; 6.6 | — |
| SECONDARY Change in Behavior |
13.3; 9.8; 10.3; 8.9; 10.8; 8.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04555616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.