Age-Related Memory Disorders, Alzheimer Dementia, Alzheimer Disease, Dementia
Conditions
Keywords
Alzheimer's disease, Age related memory disorders, Environment design, Long term care, Dementia
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.
Interventions
BEHAVIORALSalient 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.
BEHAVIORALSpaced 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.
Sponsors
Michigan State University
Grand Valley State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
62 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Wayfinding Speed (Feet Per Second) | 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. |
| Wayfinding Accuracy on Simple Route | 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). |
| Wayfinding Accuracy on Moderate and Complex Routes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Life Space | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Senior living communities were randomized, with individual participants clustered within senior living communities.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 5 |
| 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. | 57 |
| 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. | 5 |
| 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. | 50 |
| 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. | 5 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | COVID-19 Site Restrictions | 11 | 15 | 18 |
| Overall Study | Death | 2 | 2 | 7 |
| Overall Study | Decline in Health | 5 | 9 | 4 |
| Overall Study | Determined Ineligible | 0 | 0 | 1 |
| Overall Study | Investigator determined not in best interest for subject to continue | 1 | 0 | 0 |
| Overall Study | Subject Moved | 8 | 5 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Spaced Retrieval Education | Salient Cues | Control |
|---|---|---|---|---|
| Adjusted Wayfinding Speed Adjusted Wayfinding Speed (high complexity route) | 1.10 feet per second STANDARD_DEVIATION 0.67 | 1.12 feet per second STANDARD_DEVIATION 0.6 | 0.95 feet per second STANDARD_DEVIATION 0.48 | 1.29 feet per second STANDARD_DEVIATION 0.88 |
| Adjusted Wayfinding Speed Adjusted Wayfinding Speed (Low complexity route) | 2.08 feet per second STANDARD_DEVIATION 1.98 | 1.57 feet per second STANDARD_DEVIATION 1.05 | 2.91 feet per second STANDARD_DEVIATION 2.63 | 1.58 feet per second STANDARD_DEVIATION 1.36 |
| Adjusted Wayfinding Speed Adjusted Wayfinding Speed (moderate complexity route) | 1.45 feet per second STANDARD_DEVIATION 0.9 | 1.37 feet per second STANDARD_DEVIATION 0.74 | 1.61 feet per second STANDARD_DEVIATION 0.89 | 1.33 feet per second STANDARD_DEVIATION 1.05 |
| Age, Continuous | 85.07 years STANDARD_DEVIATION 5.88 | 84.26 years STANDARD_DEVIATION 6.49 | 85.59 years STANDARD_DEVIATION 6 | 85.37 years STANDARD_DEVIATION 5.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 50 Participants | 56 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 149 Participants | 50 Participants | 56 Participants | 43 Participants |
| Region of Enrollment United States | 150 participants | 50 participants | 57 participants | 43 participants |
| Sex: Female, Male Female | 118 Participants | 39 Participants | 46 Participants | 33 Participants |
| Sex: Female, Male Male | 32 Participants | 11 Participants | 11 Participants | 10 Participants |
| Tinetti Life Space | 53.25 score on a scale STANDARD_DEVIATION 15.1 | 57.96 score on a scale STANDARD_DEVIATION 16.48 | 52.61 score on a scale STANDARD_DEVIATION 13.34 | 47.63 score on a scale STANDARD_DEVIATION 12.34 |
| Wayfinding accuracy Wayfinding accuracy (high complexity route) | 0.16 proportion of possible errors on a route STANDARD_DEVIATION 0.13 | 0.14 proportion of possible errors on a route STANDARD_DEVIATION 0.13 | 0.21 proportion of possible errors on a route STANDARD_DEVIATION 0.13 | 0.12 proportion of possible errors on a route STANDARD_DEVIATION 0.12 |
| Wayfinding accuracy Wayfinding accuracy (low complexity route) | 0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.2 | 0.08 proportion of possible errors on a route STANDARD_DEVIATION 0.15 | 0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.25 | 0.12 proportion of possible errors on a route STANDARD_DEVIATION 0.2 |
| Wayfinding accuracy Wayfinding accuracy (moderate complexity route) | 0.11 proportion of possible errors on a route STANDARD_DEVIATION 0.13 | 0.10 proportion of possible errors on a route STANDARD_DEVIATION 0.12 | 0.10 proportion of possible errors on a route STANDARD_DEVIATION 0.13 | 0.14 proportion of possible errors on a route STANDARD_DEVIATION 0.15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 55 | 2 / 62 | 9 / 55 |
| other Total, other adverse events | 6 / 55 | 7 / 62 | 11 / 55 |
| serious Total, serious adverse events | 4 / 55 | 9 / 62 | 6 / 55 |
Outcome results
Primary
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.
Time frame: Average over months 1, 3, 6, and 12
Population: Participants walking routes
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (high complexity route) | 1.42 feet per second | Standard Error 0.09 |
| Control | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (moderate complexity route) | 1.83 feet per second | Standard Error 0.09 |
| Control | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (low complexity route) | 2.32 feet per second | Standard Error 0.15 |
| Salient Cues | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (moderate complexity route) | 1.97 feet per second | Standard Error 0.09 |
| Salient Cues | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (low complexity route) | 2.87 feet per second | Standard Error 0.14 |
| Salient Cues | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (high complexity route) | 1.48 feet per second | Standard Error 0.08 |
| Spaced Retrieval Education | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (low complexity route) | 2.33 feet per second | Standard Error 0.14 |
| Spaced Retrieval Education | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (high complexity route) | 1.57 feet per second | Standard Error 0.08 |
| Spaced Retrieval Education | Adjusted Wayfinding Speed (Feet Per Second) | Adjusted Wayfinding Speed (moderate complexity route) | 1.81 feet per second | Standard Error 0.09 |
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: <0.0195% CI: [0.18, 0.91]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: 0.9695% CI: [-0.35, 0.37]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: <0.0195% CI: [-0.89, -0.18]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.2395% CI: [-0.09, 0.38]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.995% CI: [-0.25, 0.22]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.1795% CI: [-0.38, 0.07]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.5895% CI: [-0.16, 0.28]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.1595% CI: [-0.06, 0.37]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.3795% CI: [-0.11, 0.29]Mixed Models Analysis
Primary
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).
Time frame: Average over months 1, 3, 6, and 12
Population: Participants who completed wayfinding assessments.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on moderate route | 0.21 proportion of errors made on route | Standard Error 0.03 |
| Control | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on complex route | 0.10 proportion of errors made on route | Standard Error 0.02 |
| Salient Cues | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on moderate route | 0.14 proportion of errors made on route | Standard Error 0.02 |
| Salient Cues | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on complex route | 0.13 proportion of errors made on route | Standard Error 0.02 |
| Spaced Retrieval Education | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on moderate route | 0.12 proportion of errors made on route | Standard Error 0.02 |
| Spaced Retrieval Education | Wayfinding Accuracy on Moderate and Complex Routes | Wayfinding accuracy on complex route | 0.08 proportion of errors made on route | Standard Error 0.02 |
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.0495% CI: [0.44, 0.99]Generalized mixed model analysis
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.0195% CI: [0.39, 0.9]Generalized mixed model analysis
Comparison: The null hypothesis was that means of two arms on the moderate complexity route are equal, the alternative was that means were not equal.p-value: 0.6195% CI: [0.6, 1.35]Generalized mixed model analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.2695% CI: [0.84, 1.88]Generalized mixed model analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.2595% CI: [0.53, 1.19]Generalized mixed model analysis
Comparison: The null hypothesis was that means of two arms on the high complexity route are equal, the alternative was that means were not equal.p-value: 0.0395% CI: [0.42, 0.94]Generalized mixed model analysis
Primary
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).
Time frame: Average over months 1, 3, 6, and 12
Population: Participants who completed wayfinding.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Wayfinding Accuracy on Simple Route | 0.083 proportion of errors made on route | Standard Error 0.01 |
| Salient Cues | Wayfinding Accuracy on Simple Route | 0.046 proportion of errors made on route | Standard Error 0.01 |
| Spaced Retrieval Education | Wayfinding Accuracy on Simple Route | 0.053 proportion of errors made on route | Standard Error 0.01 |
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: 0.0495% CI: [-0.07, -0.01]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: 0.195% CI: [-0.07, 0.01]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms on the low complexity route are equal, the alternative was that means were not equal.p-value: 0.6995% CI: [-0.03, 0.04]Mixed Models Analysis
Secondary
Life Space
Tinetti's Nursing Home Life-Space Diameter scale measures life space on the scale from 0 to 100. Higher scores represent larger life space.
Time frame: Average over months 1, 3, 6, and 12
Population: Participants who completed life space assessments.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Control | Life Space | 52.63 score on a scale | Standard Error 1.36 |
| Salient Cues | Life Space | 50.91 score on a scale | Standard Error 1.2 |
| Spaced Retrieval Education | Life Space | 51.84 score on a scale | Standard Error 1.28 |
Comparison: The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.p-value: 0.3195% CI: [-5.03, 1.6]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.p-value: 0.6695% CI: [-4.23, 2.66]Mixed Models Analysis
Comparison: The null hypothesis was that means of two arms are equal, the alternative was that means were not equal.p-value: 0.5795% CI: [-2.3, 4.17]Mixed Models Analysis