DementiaPhase 2NCT03645694
Social Support Aid For People With Dementia
A Phase 2 study testing Social Support Aid in people with Dementia and Memory Loss, run by University of Minnesota.
Trial summary
The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Dementia, Memory Loss
- What is being tested?
- Social Support Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 15 Aug 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PWMCs must be:
- A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss.
- Able to complete surveys in English or Spanish
- SLUMS score of 20 or above
- Care partners of PWMCs must be:
- 21 years of age and over;
- self-identify as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'');
- indicate a willingness to use the SSA
Who cannot join
- Indicates an unwillingness to use the SSA.
About this study
The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.
Read the detailed description
This project develops a novel social support aid (SSA) to allow persons with memory concerns (PWMCs) to more fully engage in their social network and enhance their quality of life. The SSA will assist people in an early stage of dementia, e.g., Alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. It provides memory cuing by displaying the names and relationships of the people with whom PWMCs are engaged. The investigators anticipate that the SSA will offer robust support for care partners and PWMCs in various communities. The SSA is not intended to replace caregiver aids, but rather augment them to further improve quality of life. Millions of Americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. While some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. Hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. Assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial.
This phase II Small Business Innovation Research project will continue work started in phase I and complete a product. The aim of this human subjects research protocol is to evaluate whether the SSA exerts positive benefits for PWMCs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (RCT) design. The investigators hypothesize that the proposed SSA will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.
- Conditions
- Dementia, Memory Loss
- Being tested
- Social Support Aid
- Keywords
- Caregiving, Technology, Social support
- Medical subject headings
- Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Support AidDevice
Please see earlier; the social support aid technology consists of a smartphone with a facial recognition software application and a smartwatch. Up to 1,000 individuals can be enrolled in the facial recognition application. Enrollment includes typing individuals names and relationships of the person with memory concern into the application and taking pictures of PWMC's faces at multiple angles. Once enrolled and in view of the smartphone's camera, the SSA's application recognizes the individual's face and alerts the smartwatch. The watch then vibrates and displays the individuals' name and relationship to the PWMC.
| Study group | Role | What they receive |
|---|---|---|
| SSA | Experimental | Individuals with memory concerns in the experimental arm received the prototype facial recognition technology, which included a smartphone and smartwatch. The smartphone was equipped with facial recognition software application; the smartwatch communicated information with the smartphone. Persons with memory concerns and their family care partners were given a demonstration on how to utilize the technology. Receives: Device: Social Support Aid |
| Control | No intervention | Control participants did not receive the technology; at the conclusion of follow-up, all controls were offered the technology to use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dementia Quality of Life
The 21-item modified Dementia Quality of Life instrument is a self-report survey that assesses various domains of quality of life in the person wtih dementia.
Measured: Baseline, 3-months, and 6-months
Change in Cantril quality of life ladder
The Cantril quality of life ladder is a single item survey that asks respondents to rate their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the ladder).
Measured: Baseline, 3-months, and 6-months
Secondary outcomes (2)
Pleasant events and activities of person with memory concerns
The Pleasant Events and Activities-AD Schedule Short Form is a 17-item self-report survey that measures the degree of enjoyment persons with dementia have engaging in a range of activities.
Measured: 3-months and 6-months
Change in the frequency and quality of social interactions of persons with memory concerns
Series of weekly, self-report calendar measures on types and quality of social interactions, developed for this study.
Measured: Baseline, 3-months, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Nov 2016
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual with memory concerns and their family caregivers were randomly assigned to receive the facial recognition technology or usual care.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Medical Electronics, National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645694
- Sponsor's protocol ID
- 1502S63961
- Other IDs
- R44AG041667
- Status last verified
- Apr 2022
- First submitted
- 17 Aug 2018
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McCarron HR, Zmora R, Gaugler JE. A Web-Based Mobile App With a Smartwatch to Support Social Engagement in Persons With Memory Loss: Pilot Randomized Controlled Trial. JMIR Aging. 2019 Jun 18;2(1):e13378. doi: 10.2196/13378.
PubMed 31518270
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Support Aid For People With Dementia
- ClinicalTrials.gov ID
- NCT03645694
- Acronym / sponsor ID
- 1502S63961
- Conditions
- Dementia, Memory Loss
- Keywords
- Caregiving, Technology, Social support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Advanced Medical Electronics, National Institute on Aging (NIA)
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine the acceptability, utility, and preliminary effectiveness of a facial recognition technology for persons with memory concerns and their family care partners.
Detailed description
This project develops a novel social support aid (SSA) to allow persons with memory concerns (PWMCs) to more fully engage in their social network and enhance their quality of life. The SSA will assist people in an early stage of dementia, e.g., Alzheimer's disease or related dementia, who desire social interaction, but struggle to remember names and relationships. It provides memory cuing by displaying the names and relationships of the people with whom PWMCs are engaged. The investigators anticipate that the SSA will offer robust support for care partners and PWMCs in various communities. The SSA is not intended to replace caregiver aids, but rather augment them to further improve quality of life. Millions of Americans have dementia, the loss of mental functions, e.g., thinking, memory, and reasoning, which interferes with their daily functioning. While some cases of dementia are caused by medical conditions that can be treated, most cannot be reversed. Hence, the focus switches from treatment to palliative care, i.e., developing a plan to make life easier and more comfortable for individuals with dementia and their caregivers. Assistive technologies to enhance living with dementia, let alone studies that evaluate their efficacy, are underdeveloped. The proposed project aims to begin filling this scientific and clinical gap by developing a social support aid and formally evaluating its utility via a sufficiently powered randomized controlled trial.
This phase II Small Business Innovation Research project will continue work started in phase I and complete a product. The aim of this human subjects research protocol is to evaluate whether the SSA exerts positive benefits for PWMCs' social connections, communication, and quality of life via an embedded experimental mixed methods design that combines the collection and analysis of qualitative data within a traditional randomized controlled trial (RCT) design. The investigators hypothesize that the proposed SSA will exert positive benefits on the social connections, communication, and quality of life of people in early stage dementia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual with memory concerns and their family caregivers were randomly assigned to receive the facial recognition technology or usual care.
| Arm | Type | Receives |
|---|---|---|
| SSA | Experimental | Device: Social Support AidIndividuals with memory concerns in the experimental arm received the prototype facial recognition technology, which included a smartphone and smartwatch. The smartphone was equipped with facial recognition software application; the smartwatch communicated information with the smartphone. Persons with memory concerns and their family care partners were given a demonstration on how to utilize the technology. |
| Control | No intervention | –Control participants did not receive the technology; at the conclusion of follow-up, all controls were offered the technology to use. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A physician diagnosis of early-stage Alzheimer's disease, mild cognitive impairment, or a self-identified concern of memory loss.
- Able to complete surveys in English or Spanish
- SLUMS score of 20 or above
- 21 years of age and over;
- self-identify as someone who provides assistance to the PWMC because of their memory loss (these individuals are called ''care partners,'' as these individuals may or may not provide the intensive hands-on care typical of ''caregivers'');
Key exclusion criteria (1 listed)
- Indicates an unwillingness to use the SSA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Support AidPlease see earlier; the social support aid technology consists of a smartphone with a facial recognition software application and a smartwatch. Up to 1,000 individuals can be enrolled in the facial recognition application. Enrollment includes typing individuals names and relationships of the person with memory concern into the application and taking pictures of PWMC's faces at multiple angles. Once enrolled and in view of the smartphone's camera, the SSA's application recognizes the individual's face and alerts the smartwatch. The watch then vibrates and displays the individuals' name and relationship to the PWMC. | Device | SSA |
Primary outcome
Change in Dementia Quality of Life
Time frame: Baseline, 3-months, and 6-months
The 21-item modified Dementia Quality of Life instrument is a self-report survey that assesses various domains of quality of life in the person wtih dementia.
Change in Cantril quality of life ladder
Time frame: Baseline, 3-months, and 6-months
The Cantril quality of life ladder is a single item survey that asks respondents to rate their overall quality of life on a scale of 0 (bottom of the latter) to 10 (top of the ladder).
2 secondary outcomes
Pleasant events and activities of person with memory concerns
Time frame: 3-months and 6-months
Change in the frequency and quality of social interactions of persons with memory concerns
Time frame: Baseline, 3-months, and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Results publication: PubMed 31518270McCarron HR, Zmora R, Gaugler JE. A Web-Based Mobile App With a Smartwatch to Support Social Engagement in Persons With Memory Loss: Pilot Randomized Controlled Trial. JMIR Aging. 2019 Jun 18;2(1):e13378. doi: 10.2196/13378.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Social Support Aid in people with Dementia and Memory Loss, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dementia Quality of Life (time frame: Baseline, 3-months, and 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.