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

NCT06568107 | Recruiting DMC

• 2 other identifiers: 20030076935K23NR018673
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dementia

Outcome Measures

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.

  90 minutes

Secondary Outcomes (3)

• Heart Rate (HR)

  90 minutes

• Electrodermal Activity

  90 minutes

• Acceptability of Intervention Measure

  5 minutes

Study Arms (1)

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.

Behavioral: Environmental And Sensory Experience (EASE) intervention

Interventions

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.

EASE Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104-2612, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Environment; methyl hydroxyethyl cellulose; Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Investigative Techniques

Study Officials

• Justine S Sefcik

  Drexel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine S Sefcik, PhD, RN

CONTACT

6074347205; jss398@drexel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group - all participants enrolled in the study will receive the non-pharmacological intervention

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: October 31, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)