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NCT Number: NCT06568107

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Drexel University

Philadelphia, Pennsylvania, 19104-2612, United States

Location status: Recruiting

Location contact

Justine S Sefcik, PhD, RN

CONTACT

[email protected]

607-434-7205

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Environmental And Sensory Experience (EASE) intervention

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Heart Rate (HR)

    Time frame: 90 minutes

    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.

  2. Electrodermal Activity

    Time frame: 90 minutes

    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.

  3. Acceptability of Intervention Measure

    Time frame: 5 minutes

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Justine S Sefcik, PhD, RN

CONTACT

[email protected]

6074347205

Sponsors and collaborators

Lead sponsor

Drexel University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations

Acronym: EASE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Feb 6, 2025

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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