Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations

ConditionDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorDrexel University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: EASE InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
90 minutes

Secondary outcomes

1

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.

Time frame
90 minutes
2

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.

Time frame
90 minutes
3

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.

Time frame
5 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Drexel University

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator