An interventional study of Salient Cues and Spaced Retrieval Education in Alzheimer Disease, Alzheimer Dementia and Age-Related Memory Disorders, sponsored by Grand Valley State University. Completed at 2 sites in United States. Open to participants aged 62 Years and older. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Grand Valley State University · Not applicable, Interventional, and Supportive care
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.
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 172 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Grand Valley State University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Salient Cues
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.
Behavioral: Salient Cues · Behavioral: Spaced Retrieval Education
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.
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
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
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
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
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.
| Milestone | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Started | 55 | 62 | 55 |
| Completed month 0 | 43 | 57 | 50 |
| Completed month 1 | 39 | 54 | 47 |
| Completed month 3 | 35 | 52 | 46 |
| Completed month 6 | 27 | 33 | 25 |
| Completed | 25 | 28 | 21 |
| Not completed | 30 | 34 | 34 |
| Withdrew: Death | 2 | 2 | 7 |
| Withdrew: Withdrawal by subject | 3 | 3 | 0 |
| Withdrew: Subject moved | 8 | 5 | 4 |
| Withdrew: Investigator determined not in best interest for subject to continue | 1 | 0 | 0 |
| Withdrew: Covid-19 site restrictions | 11 | 15 | 18 |
| Withdrew: Decline in health | 5 | 9 | 4 |
| Withdrew: Determined ineligible | 0 | 0 | 1 |
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.
| feet per second | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Adjusted Wayfinding Speed (low complexity route) | 2.32 ± 0.15 | 2.87 ± 0.14 | 2.33 ± 0.14 |
| Adjusted Wayfinding Speed (moderate complexity route) | 1.83 ± 0.09 | 1.97 ± 0.09 | 1.81 ± 0.09 |
| Adjusted Wayfinding Speed (high complexity route) | 1.42 ± 0.09 | 1.48 ± 0.08 | 1.57 ± 0.08 |
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).
| proportion of errors made on route | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Wayfinding Accuracy on Simple Route | 0.083 ± 0.01 | 0.046 ± 0.01 | 0.053 ± 0.01 |
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).
| proportion of errors made on route | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Wayfinding accuracy on moderate route | 0.21 ± 0.03 | 0.14 ± 0.02 | 0.12 ± 0.02 |
| Wayfinding accuracy on complex route | 0.10 ± 0.02 | 0.13 ± 0.02 | 0.08 ± 0.02 |
Tinetti's Nursing Home Life-Space Diameter scale measures life space on the scale from 0 to 100. Higher scores represent larger life space.
| score on a scale | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Life Space | 52.63 ± 1.36 | 50.91 ± 1.20 | 51.84 ± 1.28 |
Collected over One year from baseline.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 7/55 (12.7%) | 4/55 (7.3%) | 6/55 (10.9%) |
| Salient Cues | 2/62 (3.2%) | 9/62 (14.5%) | 7/62 (11.3%) |
| Spaced Retrieval Education | 9/55 (16.4%) | 6/55 (10.9%) | 11/55 (20%) |
| Event | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| HospitalizationGeneral disorders | 4/55 | 7/62 | 5/55 |
| Fall with injuryGeneral disorders | 0/55 | 3/62 | 2/55 |
| Event | Control | Salient Cues | Spaced Retrieval Education |
|---|---|---|---|
| Minor IllnessGeneral disorders | 1/55 | 0/62 | 4/55 |
| Fall with injuryGeneral disorders | 2/55 | 3/62 | 3/55 |
| Fall without injuryGeneral disorders | 2/55 | 3/62 | 2/55 |
| Outpatient HospitalizationGeneral disorders | 0/55 | 1/62 | 1/55 |
| Too fatiguedGeneral disorders | 1/55 | 0/62 | 1/55 |
Baseline characteristics data were collected only on the participant level.
| Age, Continuous(years) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Mean | 85.37 ± 5.16 | 85.59 ± 6.00 | 84.26 ± 6.49 | 85.07 ± 5.88 |
| Sex: Female, Male(Participants) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Female | 33 | 46 | 39 | 118 |
| Male | 10 | 11 | 11 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 43 | 56 | 50 | 149 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 43 | 56 | 50 | 149 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| United States | 43 | 57 | 50 | 150 |
| Adjusted Wayfinding Speed(feet per second) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Adjusted Wayfinding Speed (Low complexity route) | 1.58 ± 1.36 | 2.91 ± 2.63 | 1.57 ± 1.05 | 2.08 ± 1.98 |
| Adjusted Wayfinding Speed (moderate complexity route) | 1.33 ± 1.05 | 1.61 ± 0.89 | 1.37 ± 0.74 | 1.45 ± 0.90 |
| Adjusted Wayfinding Speed (high complexity route) | 1.29 ± 0.88 | 0.95 ± 0.48 | 1.12 ± 0.60 | 1.10 ± 0.67 |
| Wayfinding accuracy(proportion of possible errors on a route) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Wayfinding accuracy (low complexity route) | 0.12 ± 0.20 | 0.11 ± 0.25 | 0.08 ± 0.15 | 0.11 ± 0.20 |
| Wayfinding accuracy (moderate complexity route) | 0.14 ± 0.15 | 0.10 ± 0.13 | 0.10 ± 0.12 | 0.11 ± 0.13 |
| Wayfinding accuracy (high complexity route) | 0.12 ± 0.12 | 0.21 ± 0.13 | 0.14 ± 0.13 | 0.16 ± 0.13 |
| Tinetti Life Space(score on a scale) | Control | Salient Cues | Spaced Retrieval Education | Total |
|---|---|---|---|---|
| Mean | 47.63 ± 12.34 | 52.61 ± 13.34 | 57.96 ± 16.48 | 53.25 ± 15.10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within six months of final publication of the data.
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.
Ran from Jun 2019 to primary completion in Aug 2023, 50 months.
Results were first posted in Nov 2024, 1 year 2 months after primary completion.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's 50 months is above that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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