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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03537729
Other study ID # P17203009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date October 23, 2023

Study information

Verified date November 2023
Source Grand Valley State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date October 23, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 62 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Salient 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 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.

Locations

Country Name City State
United States Grand Valley State University Allendale Michigan
United States Brush Development Chardon Ohio

Sponsors (2)

Lead Sponsor Collaborator
Grand Valley State University Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 months
Secondary 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. 12 months
Secondary 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. 12 months
Secondary 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. 12 months
Secondary 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. 12 months
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