NCT03537729

Brief Summary

The ability to find one's way in the world is known as wayfinding. Many older adults who live in senior communities, such as independent living and assisted living residences, find wayfinding very challenging. Often times, these communities are not designed in a way that helps people find their way very easily. When people cannot find their way, they can get lost, be dependent upon others for getting out and about, or even be afraid to leave their rooms. The purpose of this study is to find out if distinctive signs and decorative elements, along with a special type of education called Spaced-Retrieval education, help residents in these communities find their way more effectively. Twelve senior communities will be assigned by chance to one of three conditions, including: 1) control - no change (the community stays the same); 2) signs and decorative elements enhanced; and 3) signs, decorative elements, and special education added. After agreeing to be in the study, the participants will be asked to find their way to certain places in their community four times over a year. Some people will be asked to participate in educational sessions on wayfinding. In addition, some people will be asked to wear a location tracker, (like a fitness tracker), for four weeks during the year. How well people find their way, along with how much they travel about within the communities, will be compared between the three groups. It is hypothesized that those in the communities with special signs and decorative elements will find their way more effectively than those in the control communities. It is also hypothesized that participants in the communities with the special education intervention will find their way better than those without the education. Finally, it is hypothesized that participants in the communities with signs and cues and education will travel about further distances than those in the control communities. The results of the study can help people who have a tendency to get lost find their way more effectively in their community, and this could result in more independence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
1 year until next milestone

Study Start

First participant enrolled

June 12, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 4, 2024

Completed
Last Updated

November 4, 2024

Status Verified

August 1, 2024

Enrollment Period

4.2 years

First QC Date

May 4, 2018

Results QC Date

February 26, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

Alzheimer's diseaseAge related memory disordersEnvironment designLong term careDementia

Outcome Measures

Primary Outcomes (3)

  • Adjusted Wayfinding Speed (Feet Per Second)

    Subjects walked three pre-specified routes in the senior living community (simple, moderate, and complex). They were timed as they walked the route using a computer application called DOTT. Rest periods, elevator wait times and errors (wrong turns) were indicated in DOTT as the participant traversed the route. The adjusted wayfinding speed was calculated as the length of the route in linear feet divided by time in seconds the subject took to walk the route, minus rest periods and elevator wait times, plus 120 seconds added per error.

    Average over months 1, 3, 6, and 12

  • Wayfinding Accuracy on Simple Route

    Accuracy was measured via proportion of errors, calculated as number of errors made by a participant when walking a pre-specified route divided by number of possible errors on a route. Errors were defined as a subject making a wrong turn at a decision point, or a U-turn in a hallway the wrong direction. Higher value reflects lower accuracy (higher proportion of errors).

    Average over months 1, 3, 6, and 12

  • Wayfinding Accuracy on Moderate and Complex Routes

    Accuracy was measured via proportion of errors, calculated as number of errors made by a participant when walking a pre-specified route divided by number of possible errors on a route. Errors were defined as a subject making a wrong turn at a decision point, or a U-turn in a hallway the wrong direction. Higher value reflects lower accuracy (higher proportion of errors).

    Average over months 1, 3, 6, and 12

Secondary Outcomes (1)

  • Life Space

    Average over months 1, 3, 6, and 12

Study Arms (3)

Control

NO INTERVENTION

There will be no modifications to décor or signage in the existing care community, and no education on wayfinding. However, subjects will receive the same testing that is provided for the other arms at the designated time periods.

Salient Cues

EXPERIMENTAL

Special signs and salient cues will be added to the community along the routes being measured for wayfinding. The cues will be comprised of pictures, objects, and signage.

Behavioral: Salient Cues

Spaced retrieval education

EXPERIMENTAL

This condition will have signage and cues as in Arm 2 added to the care communities. In addition, a spaced retrieval (SR) memory intervention strategy will be implemented individually for each resident participating in the study to help them remember the presence and function of the environmental wayfinding cues.

Behavioral: Salient CuesBehavioral: Spaced Retrieval Education

Interventions

Salient CuesBEHAVIORAL

Salient cues are those that capture the individual's attention. Information that is complex, novel, and difficult to identify takes more processing resources than those that are simple and familiar. Cues such as pictures and wall hangings, along with bright and meaningful signs, will be placed at key decision points within the senior communities.

Salient CuesSpaced retrieval education

Spaced Retrieval (SR) is an evidence-based memory strategy that is used to teach individuals with memory loss new or previously known information. In this study, participants in Arm 3 will receive twelve 30-minute educational sessions to help them use the salient cues to find their way.

Spaced retrieval education

Eligibility Criteria

Age62 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 62 or older;
  • Wayfinding impairment identified by the subject or staff and exhibited at baseline, including problems finding their way among three defined locations (these may differ among care communities);
  • Ability to move self either independently by walking or using mobility aids (self-mobile; any mobility aids are acceptable)
  • Ability to communicate with researchers and follow directions
  • Ability to see and read signs in English.

You may not qualify if:

  • Chronic health conditions that impair the ability to participate in the study, such as severe chronic obstructive pulmonary disease (COPD) (limiting movement) or terminal illness;
  • Signs of rapid deterioration in health during the past 6 months as evidenced by staff communication or medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Grand Valley State University

Allendale, Michigan, 49401, United States

Location

Brush Development

Chardon, Ohio, 44024, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseMemory DisordersDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was conducted during a world-wide pandemic, causing cessation of study activities and participant attrition. The sample was a convenience sample; those who participated may be different than those who did not. We were unable to recruit a diverse sample due to the lack of diversity in the independent living and assisted living settings; this limits generalizability of the findings. The intraclass correlation was higher than expected due to the routes being community specific.

Results Point of Contact

Title
Dr. Rebecca Davis
Organization
Grand Valley State University

Study Officials

  • Rebecca Davis, PhD

    Grand Valley State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 25, 2018

Study Start

June 12, 2019

Primary Completion

August 30, 2023

Study Completion

October 23, 2023

Last Updated

November 4, 2024

Results First Posted

November 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The proposed research will include data from approximately 138 subjects from nine senior living communities. The final dataset will include de-identified data, including certain demographics, wayfinding data, and cognitive tests. We will make the data and associated documentation (code book, description of variables) available to users in Scholarworks. ScholarWorks@GVSU is an open-access repository maintained by the Grand Valley State University (GVSU) Libraries. It is anticipated that the data would be available after the PI has published the final results, or within two years of the completion of the study. The repository will have the de-identified data set, along with a description of each variable and any statistical formulas used to create the variable.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Within six months of final publication of the data.
Access Criteria
We will make the data and associated documentation (code book, description of variables) available to users in Scholarworks. ScholarWorks@GVSU is an open-access repository maintained by the GVSU Libraries. It is anticipated that the data would be available after the PI has published the final results, or within two years of the completion of the study. The repository will have the de-identified data set, along with a description of each variable and any statistical formulas used to create the variable.

Locations