- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537729
Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding
August 20, 2024 updated by: Rebecca Davis, Grand Valley State University
A Randomized Controlled Trial of Visual Cues, Signage, and Spaced-Retrieval Education Within Long Term Care Communities to Assist With Wayfinding
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The ability to locate and travel successfully to a destination, known as wayfinding, is a significant problem for older adults with cognitive disorders.
Relocating to a new residence such as independent or assisted living is a time in which older adults with cognitive problems are most vulnerable to experiencing wayfinding problems.
Often these communities are not designed to facilitate wayfinding as they are complex, confusing, and lack distinctiveness.
Wayfinding problems can cause individuals' worlds to shrink, leading to a smaller life space (the spatial extent of travel within the community), decreased engagement, and dependence upon others for activities of daily living.
The overall goal of the proposed project is to assess the contribution of salient visual cues and Spaced Retrieval (SR) on wayfinding ability and life space in older adults with wayfinding problems who live in senior communities.
Salient cues, such as vivid pictures, statues and bright, distinctive signage can make senior residential communities more memorable and distinctive.
This study has three specific aims: a) to examine the effect of salient cues with and without SR on wayfinding ability initially and over time in older adults who have wayfinding deficits in senior communities; and b) To determine the effects of salient visual cues and SR on life space; and c) to determine subject characteristics that are most amenable to the intervention; wand which subject characteristics place persons at risk for less responsiveness to the intervention so that the intervention can be appropriately targeted.
There are three arms to the clinical trial to which nine care communities will be randomly assigned, including Arm 1 (control; no change to the care community); Arm 2 (colorful and familiar objects and signage placed within the care community); and Arm 3 (Arm 2 cues plus SR).
Participants will be individuals within the communities who exhibit problems finding their way.
They will be asked to find their way repeatedly to specific destinations over a period of a year.
Wayfinding performance, including how fast the participants find the test location and the errors they make compared between study Arms.
Life space will also be measured and compared between Arms.
It is hypothesized that individuals who are in care communities which are enhanced with salient cues will improve wayfinding when compared to care communities without salient cues.
In addition, Spaced Retrieval, which is an evidence-based memory strategy, is hypothesized to positively influence subjects' use of the cues and improve wayfinding performance.
Finally, it is hypothesized that wayfinding ability will correlate with life space.
The long term goals of this research are to test an evidence based intervention to enhance senior residences so that older adults who have wayfinding problems can more easily learn and remember their environments so that they can maintain independence.
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
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Allendale, Michigan, United States, 49401
- Grand Valley State University
-
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Ohio
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Chardon, Ohio, United States, 44024
- Brush Development
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
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.
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|
|
Experimental: Salient Cues
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.
|
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.
|
|
Experimental: Spaced retrieval education
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adjusted Wayfinding Speed (Feet Per Second)
Time Frame: Average over months 1, 3, 6, and 12
|
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.
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Average over months 1, 3, 6, and 12
|
|
Wayfinding Accuracy on Simple Route
Time Frame: Average over months 1, 3, 6, and 12
|
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
|
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Wayfinding Accuracy on Moderate and Complex Routes
Time Frame: Average over months 1, 3, 6, and 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life Space
Time Frame: Average over months 1, 3, 6, and 12
|
Tinetti's Nursing Home Life-Space Diameter scale measures life space on the scale from 0 to 100.
Higher scores represent larger life space.
|
Average over months 1, 3, 6, and 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Davis, PhD, Grand Valley State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2019
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
October 23, 2023
Study Registration Dates
First Submitted
May 4, 2018
First Submitted That Met QC Criteria
May 15, 2018
First Posted (Actual)
May 25, 2018
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
August 20, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P17203009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Within six months of final publication of the data.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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