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Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding

Primary Purpose

Alzheimer Disease, Alzheimer Dementia, Age-Related Memory Disorders

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Salient Cues
Spaced Retrieval Education
Sponsored by
Grand Valley State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer's disease, Age related memory disorders, Environment design, Long term care, Dementia

Eligibility Criteria

62 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grand Valley State University
  • Brush Development

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Salient Cues

Spaced retrieval education

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Wayfinding Speed at 12 months
Wayfinding speed is a single value, and is calculated using the following formula: v=(total distance) / (total time) for the subject to find his/her way from the starting to end point of the route. Wayfinding speed will be compared between baseline and 12 months.

Secondary Outcome Measures

Change in wayfinding errors at 12 months
Wayfinding errors are calculated by dividing the number of wrong turns (errors) made on a route by the number of possible turns. This value will be compared between baseline and 12 months.
Change in Life Space at 12 months
Life space is defined as the spatial extent of mobility within an environment, and varies from a small life space (limited to one's room) to a large life space (travels outside of the care community). Life space will be measured using a modified version of Tinetti's Nursing Home Life-Space Diameter and scores will be compared between baseline and 12 months.
Change in Spatial Tracking - Life space at 12 months
For a sub-sample, an electronic monitoring device will provide data regarding the life space of participants. The location of the participants will be mapped onto Tinetti's life space zones and the extent of life space will be compared between baseline and the end of the study at 12 months.
Change in Spatial Tracking (Time spent at each life space zone) at 12 months
For a subsample, an electronic monitoring device will provide data regarding the life space of participants. The amount of time in seconds will be recorded for each life space zone. This value will be compared from baseline to the end of the study at 12 months.

Full Information

First Posted
May 4, 2018
Last Updated
November 17, 2022
Sponsor
Grand Valley State University
Collaborators
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT03537729
Brief Title
Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding
Official Title
A Randomized Controlled Trial of Visual Cues, Signage, and Spaced-Retrieval Education Within Long Term Care Communities to Assist With Wayfinding
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Grand Valley State University
Collaborators
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Alzheimer Dementia, Age-Related Memory Disorders, Dementia
Keywords
Alzheimer's disease, Age related memory disorders, Environment design, Long term care, Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Salient Cues
Arm Type
Experimental
Arm Description
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.
Arm Title
Spaced retrieval education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Salient Cues
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spaced Retrieval Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Wayfinding Speed at 12 months
Description
Wayfinding speed is a single value, and is calculated using the following formula: v=(total distance) / (total time) for the subject to find his/her way from the starting to end point of the route. Wayfinding speed will be compared between baseline and 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in wayfinding errors at 12 months
Description
Wayfinding errors are calculated by dividing the number of wrong turns (errors) made on a route by the number of possible turns. This value will be compared between baseline and 12 months.
Time Frame
12 months
Title
Change in Life Space at 12 months
Description
Life space is defined as the spatial extent of mobility within an environment, and varies from a small life space (limited to one's room) to a large life space (travels outside of the care community). Life space will be measured using a modified version of Tinetti's Nursing Home Life-Space Diameter and scores will be compared between baseline and 12 months.
Time Frame
12 months
Title
Change in Spatial Tracking - Life space at 12 months
Description
For a sub-sample, an electronic monitoring device will provide data regarding the life space of participants. The location of the participants will be mapped onto Tinetti's life space zones and the extent of life space will be compared between baseline and the end of the study at 12 months.
Time Frame
12 months
Title
Change in Spatial Tracking (Time spent at each life space zone) at 12 months
Description
For a subsample, an electronic monitoring device will provide data regarding the life space of participants. The amount of time in seconds will be recorded for each life space zone. This value will be compared from baseline to the end of the study at 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Davis, PhD
Organizational Affiliation
Grand Valley State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Valley State University
City
Allendale
State/Province
Michigan
ZIP/Postal Code
49401
Country
United States
Facility Name
Brush Development
City
Chardon
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding

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