Trial Outcomes & Findings for Effects of Visual Cues and Education for People Who Live Within Long Term Care Communities to Assist in Wayfinding (NCT NCT03537729)

Last Updated: 2024-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

172 participants

Primary outcome timeframe

Average over months 1, 3, 6, and 12

Results posted on

2024-11-04

Participant Flow

Fifteen senior living communities were enrolled and randomized to one of three arms between June 2019 and June 2022. Residents (individual participants) were recruited from each community. The first participant was enrolled on June 12, 2019 and the last was enrolled on June 16, 2022. There was a significant pause in enrollment due to the COVID-19 pandemic.

Senior living communities were randomized, with individual participants clustered within senior living communities.

Unit of analysis: Senior Living Communities

Participant milestones

Participant milestones
Measure	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.	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: 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 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: 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.
Overall Study STARTED	55 5	62 5	55 5
Overall Study Completed Month 0	43 5	57 5	50 5
Overall Study Completed Month 1	39 5	54 5	47 5
Overall Study Completed Month 3	35 5	52 5	46 5
Overall Study Completed Month 6	27 3	33 3	25 3
Overall Study COMPLETED	25 3	28 3	21 3
Overall Study NOT COMPLETED	30 2	34 2	34 2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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: 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 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: 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.
Overall Study Death	2	2	7
Overall Study Withdrawal by Subject	3	3	0
Overall Study Subject Moved	8	5	4
Overall Study Investigator determined not in best interest for subject to continue	1	0	0
Overall Study COVID-19 Site Restrictions	11	15	18
Overall Study Decline in Health	5	9	4
Overall Study Determined Ineligible	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=5 Senior Living Communities 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 n=5 Senior Living Communities 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: 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 n=5 Senior Living Communities 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: 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.	Total n=15 Senior Living Communities Total of all reporting groups
Age, Continuous	85.37 years STANDARD_DEVIATION 5.16 • n=5 Participants	85.59 years STANDARD_DEVIATION 6.00 • n=7 Participants	84.26 years STANDARD_DEVIATION 6.49 • n=5 Participants	85.07 years STANDARD_DEVIATION 5.88 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	46 Participants n=7 Participants	39 Participants n=5 Participants	118 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	32 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	56 Participants n=7 Participants	50 Participants n=5 Participants	149 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	56 Participants n=7 Participants	50 Participants n=5 Participants	149 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	57 participants n=7 Participants	50 participants n=5 Participants	150 participants n=4 Participants
Adjusted Wayfinding Speed Adjusted Wayfinding Speed (Low complexity route)	1.58 feet per second STANDARD_DEVIATION 1.36 • n=5 Participants	2.91 feet per second STANDARD_DEVIATION 2.63 • n=7 Participants	1.57 feet per second STANDARD_DEVIATION 1.05 • n=5 Participants	2.08 feet per second STANDARD_DEVIATION 1.98 • n=4 Participants
Adjusted Wayfinding Speed Adjusted Wayfinding Speed (moderate complexity route)	1.33 feet per second STANDARD_DEVIATION 1.05 • n=5 Participants	1.61 feet per second STANDARD_DEVIATION 0.89 • n=7 Participants	1.37 feet per second STANDARD_DEVIATION 0.74 • n=5 Participants	1.45 feet per second STANDARD_DEVIATION 0.90 • n=4 Participants
Adjusted Wayfinding Speed Adjusted Wayfinding Speed (high complexity route)	1.29 feet per second STANDARD_DEVIATION 0.88 • n=5 Participants	0.95 feet per second STANDARD_DEVIATION 0.48 • n=7 Participants	1.12 feet per second STANDARD_DEVIATION 0.60 • n=5 Participants	1.10 feet per second STANDARD_DEVIATION 0.67 • n=4 Participants
Wayfinding accuracy Wayfinding accuracy (low complexity route)	0.12 proportion of possible errors on a route STANDARD_DEVIATION 0.20 • n=5 Participants	0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.25 • n=7 Participants	0.08 proportion of possible errors on a route STANDARD_DEVIATION 0.15 • n=5 Participants	0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.20 • n=4 Participants
Wayfinding accuracy Wayfinding accuracy (moderate complexity route)	0.14 proportion of possible errors on a route STANDARD_DEVIATION 0.15 • n=5 Participants	0.10 proportion of possible errors on a route STANDARD_DEVIATION 0.13 • n=7 Participants	0.10 proportion of possible errors on a route STANDARD_DEVIATION 0.12 • n=5 Participants	0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.13 • n=4 Participants
Wayfinding accuracy Wayfinding accuracy (high complexity route)	0.12 proportion of possible errors on a route STANDARD_DEVIATION 0.12 • n=5 Participants	0.21 proportion of possible errors on a route STANDARD_DEVIATION 0.13 • n=7 Participants	0.14 proportion of possible errors on a route STANDARD_DEVIATION 0.13 • n=5 Participants	0.16 proportion of possible errors on a route STANDARD_DEVIATION 0.13 • n=4 Participants
Tinetti Life Space	47.63 score on a scale STANDARD_DEVIATION 12.34 • n=5 Participants	52.61 score on a scale STANDARD_DEVIATION 13.34 • n=7 Participants	57.96 score on a scale STANDARD_DEVIATION 16.48 • n=5 Participants	53.25 score on a scale STANDARD_DEVIATION 15.10 • n=4 Participants

PRIMARY outcome

Timeframe: Average over months 1, 3, 6, and 12

Population: Participants walking routes

Outcome measures

Outcome measures
Measure	Control n=43 Participants 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 n=57 Participants 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: 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 n=50 Participants 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: 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.
Adjusted Wayfinding Speed (Feet Per Second) Adjusted Wayfinding Speed (low complexity route)	2.32 feet per second Standard Error 0.15	2.87 feet per second Standard Error 0.14	2.33 feet per second Standard Error 0.14
Adjusted Wayfinding Speed (Feet Per Second) Adjusted Wayfinding Speed (moderate complexity route)	1.83 feet per second Standard Error 0.09	1.97 feet per second Standard Error 0.09	1.81 feet per second Standard Error 0.09
Adjusted Wayfinding Speed (Feet Per Second) Adjusted Wayfinding Speed (high complexity route)	1.42 feet per second Standard Error 0.09	1.48 feet per second Standard Error 0.08	1.57 feet per second Standard Error 0.08

PRIMARY outcome

Timeframe: Average over months 1, 3, 6, and 12

Population: Participants who completed wayfinding.

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).

Outcome measures

Outcome measures
Measure	Control n=43 Participants 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 n=57 Participants 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: 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 n=50 Participants 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: 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.
Wayfinding Accuracy on Simple Route	0.083 proportion of errors made on route Standard Error 0.01	0.046 proportion of errors made on route Standard Error 0.01	0.053 proportion of errors made on route Standard Error 0.01

PRIMARY outcome

Timeframe: Average over months 1, 3, 6, and 12

Population: Participants who completed wayfinding assessments.

Outcome measures

Outcome measures
Measure	Control n=43 Participants 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 n=57 Participants 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: 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 n=50 Participants 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: 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.
Wayfinding Accuracy on Moderate and Complex Routes Wayfinding accuracy on moderate route	0.21 proportion of errors made on route Standard Error 0.03	0.14 proportion of errors made on route Standard Error 0.02	0.12 proportion of errors made on route Standard Error 0.02
Wayfinding Accuracy on Moderate and Complex Routes Wayfinding accuracy on complex route	0.10 proportion of errors made on route Standard Error 0.02	0.13 proportion of errors made on route Standard Error 0.02	0.08 proportion of errors made on route Standard Error 0.02

SECONDARY outcome

Timeframe: Average over months 1, 3, 6, and 12

Population: Participants who completed life space assessments.

Tinetti's Nursing Home Life-Space Diameter scale measures life space on the scale from 0 to 100. Higher scores represent larger life space.

Outcome measures

Outcome measures
Measure	Control n=43 Participants 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 n=57 Participants 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: 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 n=50 Participants 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: 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.
Life Space	52.63 score on a scale Standard Error 1.36	50.91 score on a scale Standard Error 1.20	51.84 score on a scale Standard Error 1.28

Adverse Events

Control

Serious events: 4 serious events

Other events: 6 other events

Deaths: 7 deaths

Salient Cues

Serious events: 9 serious events

Other events: 7 other events

Deaths: 2 deaths

Spaced Retrieval Education

Serious events: 6 serious events

Other events: 11 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Control n=55 participants at risk 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 n=62 participants at risk 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: 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 n=55 participants at risk 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: 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.
General disorders Hospitalization	7.3% 4/55 • Number of events 4 • One year from baseline.	11.3% 7/62 • Number of events 9 • One year from baseline.	9.1% 5/55 • Number of events 5 • One year from baseline.
General disorders Fall with injury	0.00% 0/55 • One year from baseline.	4.8% 3/62 • Number of events 3 • One year from baseline.	3.6% 2/55 • Number of events 2 • One year from baseline.

Other adverse events

Other adverse events
Measure	Control n=55 participants at risk 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 n=62 participants at risk 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: 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 n=55 participants at risk 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: 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.
General disorders Outpatient Hospitalization	0.00% 0/55 • One year from baseline.	1.6% 1/62 • Number of events 1 • One year from baseline.	1.8% 1/55 • Number of events 1 • One year from baseline.
General disorders Fall with injury	3.6% 2/55 • Number of events 2 • One year from baseline.	4.8% 3/62 • Number of events 3 • One year from baseline.	5.5% 3/55 • Number of events 3 • One year from baseline.
General disorders Fall without injury	3.6% 2/55 • Number of events 2 • One year from baseline.	4.8% 3/62 • Number of events 3 • One year from baseline.	3.6% 2/55 • Number of events 2 • One year from baseline.
General disorders Minor Illness	1.8% 1/55 • Number of events 1 • One year from baseline.	0.00% 0/62 • One year from baseline.	7.3% 4/55 • Number of events 4 • One year from baseline.
General disorders Too fatigued	1.8% 1/55 • Number of events 1 • One year from baseline.	0.00% 0/62 • One year from baseline.	1.8% 1/55 • Number of events 1 • One year from baseline.

Additional Information

Dr. Rebecca Davis

Grand Valley State University

Phone: 616.331.3079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place