DementiaEASENCT06568107
Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
A study testing Environmental And Sensory Experience (EASE) intervention in people with Dementia, run by Drexel University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Environmental And Sensory Experience (EASE) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104-2612
Justine S Sefcik, PhD, RN, 607-434-7205, jss398@drexel.edu
About this study
Official title: A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Environmental And Sensory Experience (EASE) intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental And Sensory Experience (EASE) interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EASE Intervention | Experimental | Thirty-two persons with dementia will be exposed by an interventionist to an Environmental And Sensory Experience (EASE) intervention which involves a tailored, person-centered nature scene projected with associated nature sounds. A within-person design will be used where the participants will serve as their own controls and be observed 30 minutes prior to, 30 minutes during, and for 30 minutes directly after EASE. Receives: Behavioral: Environmental And Sensory Experience (EASE) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Vocalizations (PVs)
Persistent vocalization (PV) duration will be recorded for the 90 minutes (prior to-, during-, and immediately after the EASE), and calculated for the 30 minutes prior to the intervention, the 30 minutes during the intervention, and 30 minutes immediately following the intervention. The interventionist will be video recording the participant only during the 90-minute observation time period. Digital video recording in this study will allow for quantifying start and stop times of the PVs to measure frequency and duration of PVs. A PV will be considered ended once it had stopped for 5 seconds. Duration of PVs will be tracked real-time on a paper form if the legally authorized representative opts out of video recording. A decline to video record option is present on the informed consent form, and if selected will not exclude participant. Analysis will involve looking at the duration and frequency of PVs during the 3- time points.
Measured: 90 minutes
Secondary outcomes (3)
Heart Rate (HR)
Heart rate will be collected via a wrist sensor 30 minutes prior to the intervention, the 30 minutes during the intervention, and 30 minutes immediately following the intervention. Analysis will include looking at heart rates during the 3-time points.
Measured: 90 minutes
Electrodermal Activity
Electrodermal activity will be collected via a wrist sensor 30 minutes prior to the intervention, the 30 minutes during the intervention, and 30 minutes immediately following the intervention. Analysis will include looking at heart rates during the 3-time points.
Measured: 90 minutes
Acceptability of Intervention Measure
This structured survey poses 4 statements, allows for customization to insert intervention name, and has the respondents use a 5-point Likert from completely disagree to completely agree. The statements are: 1) the EASE meets my approval, 2) the EASE is appealing to me, 3) I like EASE, and 4) I welcome EASE. Stakeholder NH staff (Nurses, Nursing Assistants and Administrators) working on the unit the participants live on will we be asked these questions with 48 hours following the intervention delivery.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start31 Oct 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group - all participants enrolled in the study will receive the non-pharmacological intervention
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Justine S Sefcik, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568107
- Sponsor's protocol ID
- 2003007693
- Other IDs
- 5K23NR018673
- Acronym
- EASE
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
- ClinicalTrials.gov ID
- NCT06568107
- Acronym / sponsor ID
- EASE / 2003007693
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group - all participants enrolled in the study will receive the non-pharmacological intervention
| Arm | Type | Receives |
|---|---|---|
| EASE Intervention | Experimental | Behavioral: Environmental And Sensory Experience (EASE) interventionThirty-two persons with dementia will be exposed by an interventionist to an Environmental And Sensory Experience (EASE) intervention which involves a tailored, person-centered nature scene projected with associated nature sounds. A within-person design will be used where the participants will serve as their own controls and be observed 30 minutes prior to, 30 minutes during, and for 30 minutes directly after EASE. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Environmental And Sensory Experience (EASE) interventionThe 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. | Behavioural | EASE Intervention |
Primary outcome
Persistent Vocalizations (PVs)
Time frame: 90 minutes
Persistent vocalization (PV) duration will be recorded for the 90 minutes (prior to-, during-, and immediately after the EASE), and calculated for the 30 minutes prior to the intervention, the 30 minutes during the intervention, and 30 minutes immediately following the intervention. The interventionist will be video recording the participant only during the 90-minute observation time period. Digital video recording in this study will allow for quantifying start and stop times of the PVs to measure frequency and duration of PVs. A PV will be considered ended once it had stopped for 5 seconds. Duration of PVs will be tracked real-time on a paper form if the legally authorized representative opts out of video recording. A decline to video record option is present on the informed consent form, and if selected will not exclude participant. Analysis will involve looking at the duration and frequency of PVs during the 3- time points.
3 secondary outcomes
Heart Rate (HR)
Time frame: 90 minutes
Electrodermal Activity
Time frame: 90 minutes
Acceptability of Intervention Measure
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
Justine S Sefcik principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental And Sensory Experience (EASE) intervention in people with Dementia, run by Drexel University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justine S Sefcik, PhD, RN (6074347205, jss398@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Vocalizations (PVs) (time frame: 90 minutes). 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 6 Feb 2025.