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The number of people living with dementia is rapidly increasing. With dementia’s impact on memory, communication, and self-identity, it is important to identify ways of meeting individual needs of diagnosed individuals and their caregivers. This study will test a new intervention, SENSE-GARDEN, that integrates autobiographical music, films, pictures, and scents with innovative technology to create an immersive environment tailored specifically for the individual.
The SENSE-GARDEN study is an Active Assisted Living Program–funded multicenter project. The primary objective of the study is to assess whether a personalized, innovative technology-based intervention can improve the well-being of older adults living with moderate to severe dementia. The study will also assess whether the intervention can improve coping and reduce burden in caregivers.
A controlled before-after study design will be used. There will be 3 sites in 3 trial countries: Belgium, Norway, and Portugal. A total of 55 people with dementia (PWDs) will be recruited. All eligible participants for the study will be randomized into the intervention or control group. For the first three months of the study, all participants will receive the SENSE-GARDEN intervention. For the final month of the study, the intervention group will continue visits to the SENSE-GARDEN, and the control group will discontinue visits. A mixed-methods approach will be used, including the use of standardized outcome measures, quantitative physiological data, and qualitative interview data.
The trials commenced recruitment in August 2019, and all data are expected to be collected by the end of May 2020. A user-centered design process is underway, with results from the first phase of user interviews indicating that people with mild cognitive impairment, family caregivers, and professional caregivers consider the SENSE-GARDEN to be a potentially valuable tool in providing numerous benefits to dementia care. Feasibility testing of the SENSE-GARDEN has been completed and results are expected to be published in October 2019.
Findings from the SENSE-GARDEN trials will provide insights into the use of technology for personalizing interventions to the PWD. This will have potential implications on not only dementia research, but it may also have influences on care practice.
DERR1-10.2196/14096
Dementia is an umbrella term for a variety of neurodegenerative diseases that most often affect memory, behavior, and communicative abilities [
People with dementia (PWDs) progressively disconnect from the world; they experience loss of function, especially memory, affecting their cognition, physical activity, and verbal and nonverbal communication. A person’s ability to communicate with others progressively worsens during the course of dementia, which can lead to the individual engaging in problem behaviors as an expression of unmet needs [
Continuing social contact with others and participating in activities is important for maintaining quality of life. Participating in past pleasant activities has an impact on functional ability and psychological well-being for PWDs living in residential care [
In recent years, studies have identified numerous complex needs of PWDs living in long-term care. These include management of challenging behaviors, maintenance of social relationships, involvement of people with cognitive deficits in meaningful activities, and supporting the emotional needs of all [
The study is performed as part of the SENSE-GARDEN EU project, funded by the Active Assisted Living (AAL) Program Call 2016. It is a 3-year project that brings together a consortium of partners across Belgium, Norway, Portugal, and Romania. This multidisciplinary project is embracing a user-centered design approach throughout the development and implementation of the intervention. The SENSE-GARDEN intervention addresses the need for individualized approaches to dementia care by creating a multisensory environment that automatically adapts to the individual with dementia. Through integrating autobiographical music, films, images, and scent with technology, the SENSE-GARDEN is able to offer an immersive experience tailored specifically for the individual based on an individual profile including preferences in music, images, videos, and personal media, such as family photos.
The project aims at creating virtual spaces that are automatically adaptable to the personal memories and individual preferences of the users. The design of the space is shown in
The rationale to include these elements in the SENSE-GARDEN intervention stems from the current evidence base of ways to improve the well-being of PWDs. For instance, there has been an increasing amount of research on combining biographical information with multimedia apps to create digital
Research also suggests that there is potential to use technology to create immersive environments in dementia care. A recent study investigated the effects of a
Considering the promising results of these studies, the innovative approach of SENSE-GARDEN has the potential to provide numerous benefits to its users. Together, it was anticipated that the integration of these components and various stimuli would complement each other to create an immersive environment that the PWD can connect with, for example, pictures of forest scenery could be combined with the sound of singing birds and the odor of a pine forest. Other scenarios may include seas, streets, the beach, urban, or rural areas according to the most meaningful memories of each individual PWD. Having this immersive environment tailored to the individual memories of each user will create a connection to the more active areas of the memory; such stimuli may result in various types of emotional states.
Another important aspect of SENSE-GARDEN is the aim to support PWDs in sharing their life story with a caregiver. The theoretical underpinnings of this aim can be linked to previous study conducted on dementia and narrative. The literature has commented on the important role of digital media in conveying narratives and supporting meaningful conversations for PWDs and their caregivers [
Relatives will have a key role in the initial adaptation of the space by providing information regarding the past of the user. After this initial setting, the SENSE-GARDEN will automatically adjust to the individual person. Feedback during the sessions will allow the SENSE-GARDEN system to learn the preferences of each user, meaning that the sessions will become increasingly personalized with each visit.
Architectural sketches of the SENSE-GARDEN space (left:interior, right: exterior).
The study will test operational SENSE-GARDENs installed in the 3 study sites: Belgium, Norway, and Portugal. With these countries, a large coverage of the European context is achieved, allowing to study cultural, social, economic, and legal differences between the countries and European regions. The primary objective of this study is to determine whether the delivery of the innovative technology developed in SENSE-GARDEN can improve well-being in older adults with intermediate to advanced dementia. The WHO defines health as the “state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity” [
The study will examine 2 quantitative and 2 qualitative primary outcomes for the PWD, namely, reduction in behavioral and psychological symptoms in dementia (BPSD), improvement in cognitive function, increase in the feeling of social presence, and an increase in self-awareness and engagement. The primary outcomes for the informal caregiver (family caregivers) are a reduction in carer burden, improvement in carer coping and relief from stress, an increased quality of visits from the informal caregivers to the PWD, and an improvement in the quality of the relationship with their relative with dementia. The primary outcome for the professional caregiver is a reduction in caregiver burnout.
Secondary outcomes for the PWD are changes in the prescription of medication, International Classification of Functioning, Disability, and Health (ICF) scores, mortality rate compared with previous existing records, number of hospitalizations comparing control and intervention groups, and an improvement in physical function and balance.
Some interesting outcomes will be measured with an exploratory aim, but because of their nature as explained ahead, they may not allow for clear conclusions to be drawn. Instead, the purpose of these outcomes is to provide preliminary insights that can be built upon in future studies. These outcomes are as follows: a reduction in depressive symptoms and loneliness, relief from feelings related to the care burden, and improvement in quality of life.
The outcomes regarding depression and relief from feelings related to care burden are measured by means of semistructured interviews. The inclusion of people in later stages of dementia means that there may be challenges in applying these measures to all participants in the study.
A total of 4 months is a short amount of time, and therefore, it is not expected that a large improvement in the quality of life will be observed during this period. However, a small change in the quality of life may provide rationale for future longitudinal studies of the use of SENSE-GARDEN in dementia care, in which quality of life can be examined to a greater extent.
Physiological data will also be collected during the SENSE-GARDEN sessions. The Empatica E4 [
To ensure that the SENSE-GARDEN meets the needs of the users, the project has adopted a user-centered design approach to the development of the intervention. This user-centered design process is divided into 3 phases. An overview of the phases is shown in
The first phase focuses on collecting an initial impression of the user experience with nonfunctional low-fidelity prototypes of the SENSE-GARDEN (eg, mock-ups). Small groups of users will be invited to each test site to give their feedback on the overall concept of SENSE-GARDEN. These user groups will include professional care staff, family caregivers, and people living with mild cognitive impairment. Including these individuals at an early stage of the project will ensure that their views are incorporated into the development of SENSE-GARDEN.
The second phase focuses on creating experiences for individual users and aims at gaining a deeper understanding of the users’ needs and requirements. An Alpha version of the SENSE-GARDEN system will be available for this phase of testing. This initial prototype of the SENSE-GARDEN will be tested in a controlled environment. Following the test, a semistructured interview will be conducted with the user to gain a rich insight into their experience.
The third phase involves feasibility testing of the system in the form of pretrials. A small number of users will be recruited at each site (1-2 users). The SENSE-GARDEN test will be tailored to each individual user by using personalized media content, such as family photographs, videos from holidays, and favorite music. The purpose of these tests is to not only ensure that the system works but also define the process of creating individualized experiences for each user.
For the full trials, a controlled before-after study design will be used. The timeline for the study is shown in
The study will start in August 2019, with a recruiting period of 6 months. The intervention period for each participant will be 3 months, followed by 1 month in either the intervention or control condition. The total study period will be 10 months.
Overview of user centred design process.
Study timeline.
There will be 3 sites in 3 trial countries: Belgium, Norway, and Portugal. With these countries, a large coverage of the European context is achieved, allowing to study cultural, social, economic, and legal differences between the countries and European regions.
The test site in Belgium will be Aan de Beverdijk care home based in Hamont-Achel. This care home is part of the VULPIA group, a care provider that comprises 22 elderly care homes. Aan de Beverdijk focuses on providing tailored care based on the individual needs of its 90 residents. The test site in Norway will be Odda sjukeheim, a municipality-based care home for the elderly based in the center of Hardanger. The test site in Portugal will be the Lar Santa Joana Princesa care home for the elderly. This care home is a part of the Santa Casa de Misericórdia de Lisboa (SCML). SCML operates according to a humanitarian goal, and its care homes focus on promoting the quality of life of its residents.
Although it is inevitable that there will be differences among care homes, the SENSE-GARDEN space at each site is being custom-built for the specific purposes of this project. Each SENSE-GARDEN will have the same equipment, the same software and will be in a closed, private room. Having a controlled space at each test site will help reduce the amount of variability among the 3 countries.
This study will recruit a total of 55 PWDs living in care facilities, in a multisite trial with 3 sites. Details for each site are as follows: (1) Belgium—1 study site, 25 PWDs, 25 informal caregivers, and 3 professional caregivers, (2) Norway—1 study site, 15 PWDs, 15 informal caregivers, and 3 professional caregivers, and (3) Portugal—1 study site, 15 PWDs, 15 informal caregivers, and 3 professional caregivers.
Participants will be recruited at each study site by a professional caregiver from the SENSE-GARDEN team. The caregivers will inform potential participants about the study with the use of an information leaflet about the project. The potential participants who are interested in the study can then voluntarily express their willingness to participate. The participants who do not express an interest will not be contacted by the project team.
Professional caregivers included in the study will have at least 6 months experience in caring for dementia patients and a background in either nursing, occupational therapy, or physiotherapy or another relevant background when supported by long-term professional experience as a caregiver.
Before the study, the professional caregiver will have a 1-week training in SENSE-GARDEN use. This training comprises guidance on how to collect information from the participant and/or their family members for creating a user profile, upload media contents to the SENSE-GARDEN system, create
Each potential participant will undergo an assessment by a health professional for the evaluation of inclusion and exclusion criteria. For the participants fulfilling the criteria, a randomization to the intervention or control group will be performed.
To be included in the study, the participant must be aged ≥55 years and living with dementia in stage 2 (moderate) or stage 3 (severe) according to the Clinical Dementia Rating (CDR) Scale [
Other severe psychiatric disturbance diagnosed by Diagnostic and Statistical Manual of Mental Disorders (4th Edition, Text Revision) criteria, concurrent severe medical condition (extreme or disabling comorbidities), or physical disability not allowing participation in the SENSE-GARDEN activities.
The informal caregiver should be a family member or close friend of the PWD. There will be at least 1 informal caregiver for each PWD recruited.
There is no age limit for the informal caregivers; they should have a computer and internet connection and provide signed informed consent to participate.
During the 3 months of the intervention period, the PWD will visit the SENSE-GARDEN on an average of 3 times per week. Each participant should visit the SENSE-GARDEN a minimum of 25 times during the intervention period. Any participant who visits less than 25 times will be considered a dropout. On each visit to the SENSE-GARDEN, the PWD is accompanied by 1 caregiver (formal or informal). It is desirable that approximately one-third of the visits are performed with an informal caregiver.
Logs of interaction with the system will be collected continuously, including visit time and duration and system feedback given by the caregivers (through a tablet interface).
Observations will be made at 3 of the SENSE-GARDEN sessions during the intervention period. During this time, measurements on social presence and physical activity will be collected. Video recording will be required during the 3 observation sessions. The recordings will solely be used for data analysis and will not be shared. They will be accessible only to authorized researchers in charge of data analysis. Video recordings will only be made during sessions involving participants that have given their informed consent to being recorded.
For the control period, visits from the family will be logged during normal care.
The methods include the following types of data collection: self-reported measures, questionnaires, interviews, and observations. For interviews and questionnaires requiring the participation of the PWD, the capacity of the PWD to provide information will be considered. In the case of participants that are not competent to provide input, the tests will be performed with a proxy who will provide information on the patient’s behalf. In some cases, the presence of both the PWD and proxy will be considered.
The CDR Scale [
To decide how to best tailor the SENSE-GARDEN intervention to each individual participant, the Adolescent/Adult Sensory Profile will be used [
The following measures will be applied at baseline (T0), 4-week follow-up (T1), 12-week follow-up (T2), and a final follow-up at 16 weeks (T3). An overview of these measures is given in
Overview of outcome measures.
Outcome | Measurement | Timepoint | |
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A reduction in BPSDa | CMAIb and BANS-Sc | T0d, T1e, T2f, T3g | |
Improvement in quality of life | QUALIDh | T0, T1, T2, T3 | |
Reduction in depressive symptoms and loneliness | CSDDi | T0, T1, T2, T3 | |
Increase in the feeling of social presence | OERSj, OMEk, VNVIS-CRl | T1m, T2m, T3m | |
Improvement in cognitive function | Mini-Cogn, FASTo, GDSp | T0, T1, T2, T3 | |
Relief from feelings related to the care burden | Semistructured interview | T3 | |
Increase in self-awareness and engagement | Audio recordings analyzed using conversation analysis | T1m, T2m, T3m | |
ICFq scores | WHODAS 2.0r | T0, T1, T2, T3 | |
Prescription of medication | Medical records | T0, T1, T2, T3 | |
Mortality rate compared with previous existing records | Medical records | T0, T1, T2, T3 | |
Number of hospitalizations comparing control and intervention groups | Medical records | T0, T1, T2, T3 | |
Exploration of physiological data including electrodermal activity and heart rate | Empatica E4 wristband | T1m, T2m, T3m | |
Improvement in physical function and balance | FRTs | T0, T1, T2, T3 | |
|
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A reduction in caregiver burden | ZBIt | T0, T1, T2, T3 | |
Improvement in caregiver coping and relief from stress | Brief-COPEu | T0, T1, T2, T3 | |
An increased quality of visits to the person with dementia | FAVS-Dv | T0, T1, T2, T3 | |
An improvement in the quality of relationship with the person with dementia | QCPRw | T0, T1, T2, T3 | |
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Reduction in caregiver burnout | MBI-HSSx | T0, T1, T2, T3 |
aBPSD: behavioral and psychological symptoms of dementia.
bCMAI: Cohen–Mansfield Agitation Inventory.
cBANS-S: Bedford Alzheimer Nursing Scale–Severity.
dT0: baseline.
eT1: 4-week follow-up.
fT2: 12-week follow-up.
gT3: 16-week follow-up.
hQUALID: Quality of Life in Late Stage Dementia scale.
iCSDD: Cornell Scale for Depression in Dementia.
jOERS: Observed Emotion Rating Scale.
kOME: Observational Measurement of Engagement.
lVNVIS-CR: Verbal and Nonverbal Interaction Scale.
mMeasurement to be taken during SENSE-GARDEN session.
nMini-Cog: 3-min instrument to screen for cognitive impairment in older adults.
oFAST: Functional Assessment Staging Tool.
pGDS: Global Deterioration Scale.
qICF: International Classification of Functioning, Disability and Health.
rWHODAS 2.0: World Health organization Disability Assessment Schedule 2.0.
sFRT: Functional Reach Test.
tZBI: Zarit Burden Interview.
uBrief-COPE: abbreviated version of the Coping Orientation to Problems Experienced inventory, a self-report questionnaire.
vFAVS-D: Family Visit Scale for Dementia.
wQCPR: Quality of Carer Patient Relationship scale.
xMBI-HSS: Maslach Burnout Inventory–Human Services Survey.
The Bedford Alzheimer Nursing Scale–Severity (BANS-S) [
Observational measures will be used to determine the level of social engagement in the participants with dementia. These tools will be the Observed Emotion Rating Scale (OERS) [
Observations will be made during at least 2 of the SENSE-GARDEN sessions for each participant. For participants in the intervention group, recordings will be taken during a SENSE-GARDEN session in week 4, week 12, and week 16. Participants randomized to the control group will only have recordings taken during a session in week 4 and week 12, as these individuals will no longer be visiting the SENSE-GARDEN after week 12.
The Mini-Cog [
Conversation analysis will be used to assess the PWD’s level of self-awareness and engagement with both the SENSE-GARDEN stimuli and the caregiver conducting the session. To conduct conversation analysis, audio recordings of certain SENSE-GARDEN sessions will be taken.
Medical records will be used to assess prescription of medication and mortality rate compared with previous existing record, and they will also be used to compare the number of hospitalizations between the control and intervention groups.
ICF scores will be collected using the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [
The Functional Reach Test (FRT) [
The FRT is a widely used tool to screen for balance problems in older adults. The test comprises a brief physical task that asks the individual to reach forward without moving his or her feet. The test measures the amount of maximum excursion that the individual is able to cover without losing balance or taking a step.
The Empatica E4 [
The Cornell Scale for Depression in Dementia (CSDD) [
The Quality of Life in Late Stage Dementia (QUALID) scale [
A semistructured dyadic interview will be conducted with the PWD and their family caregiver at the end of the study period. This interview will be used to explore the relationship between the 2 individuals. One factor will be the relief from feelings related to the care burden.
The Zarit Burden Interview [
The Brief-COPE [
The Family Visit Scale for Dementia [
The Quality of Carer Patient Relationship scale [
The Maslach Burnout Inventory–Human Services Survey (MBI-HSS) [
Quantitative data will be analyzed using SPSS Statistics version 25 (IMB Corp). Stratification by gender, age, and type and stage of dementia will be used to analyze the data. Repeated measures analysis of variance (ANOVA) will be used to assess whether the SENSE-GARDEN intervention has an effect on participants over time. Given the novelty of the SENSE-GARDEN intervention, it is not possible to assess the previous literature for clinically meaningful differences. However, Cohen
Cohen
For this study, repeated measures ANOVA will be performed on the data using SPSS to assess the effects of the intervention over the numerous time points (T0-T3). We estimate that a sample size of 55 will have over 80% power to detect a medium difference between means at a .05 significance level.
Qualitative interview data will be analyzed using thematic analysis [
Applications for ethical approval have been submitted by the 3 study sites in accordance to the national regulation. This study has been submitted to Norway’s Regional Committee for Medical and Health Research Ethics and is currently under assessment (document ID 1094463).
Confidentiality of private health information will be ensured according to the regulation (EU) 2016/679 (General Data Protection Regulation). All private personal data will be deidentified: every unique identifying number, characteristic, or code identifier of the individual, relatives, or employers will be removed, so that the information can be used alone or in combination with other information. The resulting data will be analyzed by a statistician to ensure that no individually identifiable health information remains.
The consent of participants will be required. They will be provided a letter of informed consent to be signed, together with an information sheet. The participants will be informed regarding the study’s aims and protocol and what involvement the study will comprise. The participants will be made aware of their right to withdraw from the study at any time. Information regarding confidentiality and data protection will be given. The letter of consent will be signed by the patient, when competent, or otherwise a legal tutor, signing as proxy.
An important ethical consideration for users is the exit strategy at the end of the project. All care organizations in the consortium have initially expressed their interest in evaluating the potential of keeping the SENSE-GARDEN after project end. The YOUSE GmbH method will be used also in connection with the exit strategy.
The trials commenced recruitment in August 2019. All data are expected to be collected by the end of May 2020. All phases of the user-centered design process have taken place, which has helped shape the development of SENSE-GARDEN. The results of the first phase have been published and presented at the Fourth International Conference on Human and Social Analytics 2018 (in press). Interviews with 52 users comprising people with mild cognitive impairment and informal and formal caregivers were conducted in November 2017. The aims of these interviews were to collect initial responses and attitudes toward the SENSE-GARDEN concept and investigate what benefits, if any, the users thought SENSE-GARDEN could provide in the care of PWDs.
The interviews were analyzed using thematic analysis [
Results from the second phase of the user-centered design process emphasized the importance of including personalized media contents. At the Norwegian test site, 3 user tests were conducted in a room with a prototype of the SENSE-GARDEN. The first test involved an 85-year-old lady with early-stage dementia and a professional caregiver. This lady did not feel
The third phase of user testing has been completed, which evaluated functional prototypes of the SENSE-GARDEN system. An example of a SENSE-GARDEN prototype is shown in
Photo of a test session using a prototype of SENSE-GARDEN.
This paper has outlined the objectives, study design, and preliminary results of an AAL-funded study, SENSE-GARDEN. To our knowledge, SENSE-GARDEN is the first intervention to combine multisensory stimuli, virtual technology, and autobiographical material to create an immersive and personalized room for PWDs. Our progress thus far has indicated the value of involving user groups in the initial stages of intervention development and has shown that these users have a positive outlook toward SENSE-GARDEN. The evaluation summary report has been provided in
A limitation of this study proposal is its small sample size. However, although the study may not be able to produce generalizable results, it will provide important insights into the use of a novel technology, such as SENSE-GARDEN for PWDs. The results will provide foundation for further study in the use of immersive, individualized environments and how these environments can be used to facilitate communication and person-centered care in residential care home environments.
A further limitation is the potential variance between the test sites. Implementing this study protocol in 3 different countries may be difficult in terms of ensuring that the SENSE-GARDEN intervention is delivered in the same manner in each care home. Cultural differences between the test sites may mean that methods of facilitation from care home staff could affect the overall SENSE-GARDEN experience, therefore, influencing the results from the study. However, all professional care staff will be given the same training on how to use the SENSE-GARDEN. This training should help to ensure that the intervention is conducted in a similar way at each test site.
Despite these limitations, this study has the potential to provide important contributions to current research on dementia care. The interdisciplinary nature of this project will allow us to evaluate the SENSE-GARDEN from multiple perspectives, such as technical, sociological, and psychological. The findings from the full trials have the potential to offer numerous implications on future research in dementia care and also in promoting person-centered care in practice.
Active Assisted Living evaluation summary report.
Active Assisted Living
analysis of variance
Bedford Alzheimer Nursing Scale–Severity
behavioral and psychological symptoms of dementia
Clinical Dementia Rating
Cohen–Mansfield Agitation Inventory
Cornell Scale for Depression in Dementia
electrodermal activity
Functional Assessment Staging Tool
Functional Reach Test
Global Deterioration Scale
International Classification of Functioning, Disability and Health
Maslach Burnout Inventory–Human Services Survey
Observed Emotion Rating Scale
Observational Measurement of Engagement
people with dementia
Quality of Life in Late Stage Dementia scale
Santa Casa de Misericórdia de Lisboa
Verbal and Nonverbal Interaction Scale
World Health Organization
WHO Disability Assessment Schedule 2.0
SENSE-GARDEN (AAL/Call2016/054-b/2017, with implementation period June 2017-May 2020) is funded by AAL Program, cofunded by the European Commission and National Funding Authorities of Norway, Belgium, Romania, and Portugal.
This protocol is based on a funded grant proposal. All coauthors contributed to the design of the study and participated in the initial user-centered design phase of the project. IC, AM, RD, MZ and MB provided clinical expertise on the decision of outcome measures. GG and AS drafted the paper. IC, KT, JS, AM, RD, MZ, MB, and WM reviewed and helped produce the final paper.
None declared.