Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Environmental And Sensory Experience (EASE) intervention.
- Who it may be relevant to
- Registry conditions: Dementia. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
Overview
The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.
Detailed description
After enrolling in the study, participants will participate in three study visits. During the first two visits, study personnel will observe the nursing home resident to collect data on the resident's vocalizing behaviors (persistent vocalizations, PVs). These visits will last for roughly six hours, one during the day shift and one during the evening shift. The third visit will last approximately 90 minutes. During this visit, study personnel will observe vocalizing behaviors before, during, and after the EASE intervention is in use. Residents will also wear a watch for all three visits that records information about their heart rate and stress levels. All visits will occur in the resident's natural environment- either their room or common space and will be scheduled at the convenience of the resident and NH staff.
The aims of the study are:
Aim 1: Examine the feasibility and preliminary efficacy of the EASE to reduce PVs among NH residents.
Aim 2: Evaluate the NH staff perception of the acceptability of the EASE within 48 hours post-intervention.
Aim 3: Examine the mechanism of action of the EASE.
Interventions
- Behavioral Environmental And Sensory Experience (EASE) intervention
The participant will be exposed to 30 minutes of a still nature image and associated nature sounds (60-80 beats per minute). An brief interview will occur with the legally authorized representative to find out what nature scene would meet the preference of the person living with dementia and persistent vocalizations.
Primary outcome measures
- Persistent Vocalizations (PVs) [Time frame: 90 minutes]
Secondary outcome measures (3)
- Heart Rate (HR) [Time frame: 90 minutes]
- Electrodermal Activity [Time frame: 90 minutes]
- Acceptability of Intervention Measure [Time frame: 5 minutes]
Eligibility criteria
Inclusion criteria
- The participants must: 1) have a medical diagnosis of dementia; 2) have severe dementia as determined by a MMSE score of ≤9 (or another cognitive test indicating severe dementia); 3) have a history of PVs per staff report; 4) be 50 years older or greater; 5) require extensive assistance by staff to ambulate or is non-ambulatory (to allow for consistent video recording). In addition, consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the participant.
Exclusion criteria
- Persons living with dementia will be excluded if they: 1) are blind; 2) are deaf; 3) give indications of dissent. Variations will be sought for gender, race and ethnicity.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Drexel University — Philadelphia
Identifiers
NCT: NCT06568107 · 2003007693 · 5K23NR018673