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

NCT ID: NCT06568107

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-07-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EASE Intervention

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.

Group Type: EXPERIMENTAL

Environmental And Sensory Experience (EASE) intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justine S Sefcik

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Locations

Drexel University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Justine S Sefcik, PhD, RN

Role: CONTACT

jss398@drexel.edu

6074347205

Facility Contacts

Justine S Sefcik, PhD, RN

Role: primary

jss398@drexel.edu

607-434-7205

Other Identifiers

5K23NR018673

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2003007693

Identifier Type: -

Identifier Source: org_study_id