DementiaNCT05703490
An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living
An observational study of Dementia and Cognitive Impairment, run by Bijan Najafi, PhD at 1 site in United States.
Trial summary
Difficulties in performing instrumental activity of daily living (IADL) is often an indicator of cognitive decline in older adults, and monitoring IADL and daily functioning can assist in early diagnosis of dementia. The current methods for assessment of IADL are often restricted to a single domain assessment (e.g. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Impairment, Alzheimer Disease
- What is being tested?
- IADLSys system
- Type of treatment
- Pill or oral medicine
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 31 Dec 2024
- Phase
- Observational
- 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 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ambulatory older adults (over 50 years old) with and without cognitive impairment.
Who may be able to join
- 50 years or older
- Ambulatory and are living independently in a residential home with a caregiver/informant
- Willing and able to provide informed consent
Who cannot join
- Under 50 years
- immobility or inability to engage in IADL that are essential for independent living
- Patients with any clinically significant medical or psychiatric condition
- Recent stroke over last 6 months
- major hearing/visual impairment
- any acute diagnosis that may impact IADL (e.g., fracture, foot ulcer, recent surgery, etc)
Show all 9Show fewer
- residing in a nursing home or are receiving hospice care
- inability to communicate in English
- are unlikely to fully comply with the follow-up protocol
Trial locations and contacts
1 site in 1 country.
About this study
Difficulties in performing instrumental activity of daily living (IADL) is often an indicator of cognitive decline in older adults, and monitoring IADL and daily functioning can assist in early diagnosis of dementia. The current methods for assessment of IADL are often restricted to a single domain assessment (e.g. managing medication), or rely on subjective reporting by the patient or caregivers. Patients with mild AD typically lack awareness of their IADL deficits and generally overestimate their functional capacity. Proxies are also not always a reliable source of information, as they have a tendency to over or underestimate IADL deficits. In some cases, a proxy is not available or does not have enough knowledge about the patient's functional capacity. Direct measures taken during performance of IADL-related tasks in the clinic have better validity and do not suffer from reporter bias. However, they allow observation of only a small set of tasks and, even then, are quite time-consuming. To date, there are no objective methods for continuous and remote monitoring and assessment of IADL. The National Institute on Aging (NIA) has identified this need and released a specific request for SBIR/STTR applications. In response, BioSensics, in collaboration with Baylor College of Medicine (BCM), proposes to develop and commercialize a robust system for objective and continuous remote monitoring of IADL. This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space.
Read the detailed description
This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space. There are two key aspects of the technology: 1) physical tags (pTAGs): a series of sensors that can be attached to various objects to monitor the user's interaction with these objects, 2) PAMSys+: a pendant wearable sensor to monitor physical activity and the user's proximity to the pTAGs. As a part of this development, the investigators will create a base station to collect and transfer data from wireless sensors and wearable pendant to a secure backend cloud. A secure website will be developed to allow caregivers and medical professionals access and view collected data. For the validation of the platform, the investigators will recruit a total of 100 participants with and without cognitive impairment (50 subjects per group). Eligible subjects will undergo one week observational study while using the system at home. The investigators hypothesize that monitoring performance of IADLs, their timing, as well as other metrics like life space size and patterns of physical activity can discriminate between groups. Furthermore, the acceptability, perception of benefit, and ease of use of IADLSys will be assessed using a technology acceptance model questionnaire (TAM) adopted for tele-health applications
- Conditions
- Dementia, Cognitive Impairment, Alzheimer Disease
- Being tested
- IADLSys system
- Keywords
- dementia, activities of daily living, MCI, Telehealth, Smart home, IOT
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IADLSys systemDiagnostic test
Subjects will receive IADLSys system which includes interactive tablet and 5 paired pTAGs (bluetooth sensors to attach to objects of interest at home). The pTAGs monitor activities of daily living to assess if they are being completed and communicate with the tablet to keep record of interactions. We anticipate IADLSys enables to distinguish between groups with and without cognitive impairment and determine the severity of cognitive impairment in the cognitive impaired group.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Impaired Group | older adults (age 50 years and older) with either clinical diagnosis of cognitive impairment or determined to have cognitive impairment based on Montreal Cognitive Assessment (MoCA) Test, score of 26 or lower Receives: Diagnostic Test: IADLSys system | |
| Cognitive Intact Group | Older adults age matched with Cognitive Impaired Group with MoCA score of greater than 26 Receives: Diagnostic Test: IADLSys system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence is assessed by self-report as well as IADLSys
Measured: 1 week
Cognitive function
Cognitive function is assessed by Montreal Cognitive Assessment (MoCA) Test. A score of 26 or lower is considered as cognitive impaired.
Measured: Baseline
Secondary outcomes (5)
Changes in acceptability, perception of benefit, and ease of use of IADLSys System from baseline to follow up
Acceptability, perception of benefit, and ease of use will be assessed using Technology Acceptance Model questionnaire (TAM) adopted for tele-health applications. Initial opinions and scores from baseline will be compared to the answers at 1 week follow up.
Measured: baseline, 1 week
History of fall
Self report history of falls will be documented at baseline
Measured: Baseline
Depression
Depression is assessed by Center for Epidemiologic Studies Depression Scale (CES-D). Score ranges from 0 to 60, higher the score indicates presence of depression.
Measured: Baseline
Life Space
The Life Space Questionnaire is a measure of the extent of mobility of older adults. Score ranges from 0-9, with higher score indicating the particpant uses more of their space regularly.
Measured: one week
Adherence to physical activity monitoring from baseline to follow up
Adherence to physical activity monitoring by wearing a validated pendant sensor from baseline to 1 week will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done for 1 week from baseline to 1 week follow up.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Nov 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: The PI has moved to another institution
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bijan Najafi, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- BioSensics
- Responsible party
- Sponsor-investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703490
- Sponsor's protocol ID
- H-43413
- Status last verified
- Mar 2025
- First submitted
- 11 Oct 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee M, Mishra RK, Momin A, El-Refaei N, Bagheri AB, York MK, Kunik ME, Derhammer M, Fatehi B, Lim J, Cole R, Barchard G, Vaziri A, Najafi B. Smart-Home Concept for Remote Monitoring of Instrumental Activities of Daily Living (IADL) in Older Adults with Cognitive Impairment: A Proof of Concept and Feasibility Study. Sensors (Basel). 2022 Sep 7;22(18):6745. doi: 10.3390/s22186745.
PubMed 36146095
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Platform for Objective Monitoring of Instrumental Activities of Daily Living
- ClinicalTrials.gov ID
- NCT05703490
- Acronym / sponsor ID
- H-43413
- Conditions
- Dementia, Cognitive Impairment, Alzheimer Disease
- Keywords
- dementia, activities of daily living, MCI, Telehealth, Smart home, IOT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI has moved to another institution
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bijan Najafi, PhDUniversity, hospital or other
- Collaborators
- BioSensics
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Jan 2023 (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.
Difficulties in performing instrumental activity of daily living (IADL) is often an indicator of cognitive decline in older adults, and monitoring IADL and daily functioning can assist in early diagnosis of dementia. The current methods for assessment of IADL are often restricted to a single domain assessment (e.g. managing medication), or rely on subjective reporting by the patient or caregivers. Patients with mild AD typically lack awareness of their IADL deficits and generally overestimate their functional capacity. Proxies are also not always a reliable source of information, as they have a tendency to over or underestimate IADL deficits. In some cases, a proxy is not available or does not have enough knowledge about the patient's functional capacity. Direct measures taken during performance of IADL-related tasks in the clinic have better validity and do not suffer from reporter bias. However, they allow observation of only a small set of tasks and, even then, are quite time-consuming. To date, there are no objective methods for continuous and remote monitoring and assessment of IADL. The National Institute on Aging (NIA) has identified this need and released a specific request for SBIR/STTR applications. In response, BioSensics, in collaboration with Baylor College of Medicine (BCM), proposes to develop and commercialize a robust system for objective and continuous remote monitoring of IADL. This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space.
Detailed description
This innovative platform, called IADLSys, will detect the timing and type of IADL for a wide range of daily functions, and will also monitor the user's physical activity and life-space. There are two key aspects of the technology: 1) physical tags (pTAGs): a series of sensors that can be attached to various objects to monitor the user's interaction with these objects, 2) PAMSys+: a pendant wearable sensor to monitor physical activity and the user's proximity to the pTAGs. As a part of this development, the investigators will create a base station to collect and transfer data from wireless sensors and wearable pendant to a secure backend cloud. A secure website will be developed to allow caregivers and medical professionals access and view collected data. For the validation of the platform, the investigators will recruit a total of 100 participants with and without cognitive impairment (50 subjects per group). Eligible subjects will undergo one week observational study while using the system at home. The investigators hypothesize that monitoring performance of IADLs, their timing, as well as other metrics like life space size and patterns of physical activity can discriminate between groups. Furthermore, the acceptability, perception of benefit, and ease of use of IADLSys will be assessed using a technology acceptance model questionnaire (TAM) adopted for tele-health applications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Impaired Group | – | Diagnostic Test: IADLSys systemolder adults (age 50 years and older) with either clinical diagnosis of cognitive impairment or determined to have cognitive impairment based on Montreal Cognitive Assessment (MoCA) Test, score of 26 or lower |
| Cognitive Intact Group | – | Diagnostic Test: IADLSys systemOlder adults age matched with Cognitive Impaired Group with MoCA score of greater than 26 |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory older adults (over 50 years old) with and without cognitive impairment.
Key inclusion criteria (3 listed)
- 50 years or older
- Ambulatory and are living independently in a residential home with a caregiver/informant
- Willing and able to provide informed consent
Key exclusion criteria (9 listed)
- Under 50 years
- immobility or inability to engage in IADL that are essential for independent living
- Patients with any clinically significant medical or psychiatric condition
- Recent stroke over last 6 months
- major hearing/visual impairment
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 |
|---|---|---|
| IADLSys systemSubjects will receive IADLSys system which includes interactive tablet and 5 paired pTAGs (bluetooth sensors to attach to objects of interest at home). The pTAGs monitor activities of daily living to assess if they are being completed and communicate with the tablet to keep record of interactions. We anticipate IADLSys enables to distinguish between groups with and without cognitive impairment and determine the severity of cognitive impairment in the cognitive impaired group. | Diagnostic test | Cognitive Impaired Group, Cognitive Intact Group |
Primary outcome
Medication adherence
Time frame: 1 week
Medication adherence is assessed by self-report as well as IADLSys
Cognitive function
Time frame: Baseline
Cognitive function is assessed by Montreal Cognitive Assessment (MoCA) Test. A score of 26 or lower is considered as cognitive impaired.
5 secondary outcomes
Changes in acceptability, perception of benefit, and ease of use of IADLSys System from baseline to follow up
Time frame: baseline, 1 week
History of fall
Time frame: Baseline
Depression
Time frame: Baseline
Life Space
Time frame: one week
Adherence to physical activity monitoring from baseline to follow up
Time frame: 1 week
Results and safety
The study was stopped early (reason given: The PI has moved to another institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Results publication: PubMed 36146095Lee M, Mishra RK, Momin A, El-Refaei N, Bagheri AB, York MK, Kunik ME, Derhammer M, Fatehi B, Lim J, Cole R, Barchard G, Vaziri A, Najafi B. Smart-Home Concept for Remote Monitoring of Instrumental Activities of Daily Living (IADL) in Older Adults with Cognitive Impairment: A Proof of Concept and Feasibility Study. Sensors (Basel). 2022 Sep 7;22(18):6745. doi: 10.3390/s22186745.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Cognitive Impairment, run by Bijan Najafi, PhD at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early (reason given: The PI has moved to another institution). Results are not available in the source record.
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?
Medication adherence (time frame: 1 week). 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 NCT05703490, 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 13 Mar 2025.