DementiaNCT04413851
Feasibility of Passive Data Collection in Dementia Subjects With Agitation
An observational study of Dementia and Alzheimer Disease, run by HealthMode Inc. at 2 sites in United States.
Trial summary
This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Vascular Dementia
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2020to 6 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible individuals who have a diagnosis of dementia and a recent history of agitation will sign an informed consent, with a legally authorized representative (LAR) when necessary, to enroll in the study.
Who may be able to join
- Male and female subjects 18 years and older.
- Subjects who have met DSM-5 criteria for Dementia (all cause)
- Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.
- Subjects resident in a group home, nursing home, or assisted living are eligible to participate.
- Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)
- Subjects who are willing and able to carry a smartphone and wear an activity tracker on their wrist or hand, alone or with the help of a caregiver.
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- Subjects who, either alone or with a caregiver, are able to operate a smartphone and wrist or hand-worn activity tracker, alone or with the help of a caregiver.
- Subjects who are in good general health prior to study participation as determined by a detailed medical history, and in the opinion of the Principal Investigator.
- Subjects, who are able to ambulate without an assistive device, or with a single point cane.
Who cannot join
- Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.
- Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virtual Research Site
New York, New York, 10001
Tucson Neuroscience Research, LLC
Tucson, Arizona, 85710
About this study
Official title: A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia
This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).
The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia, Frontotemporal Dementia, Lewy Body Dementia, Mixed Dementia
- Medical subject headings
- Dementia, Alzheimer Disease, Dementia, Vascular, Frontotemporal Dementia, Lewy Body Disease, Mixed Dementias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dementia | Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of passive and continuous data collection
Total time and percentage of continuous data collection for each stream of data aiming for >50% coverage.
Measured: 28 days
Secondary outcomes (1)
Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.
Caregiver and Staff engagement with the eCOA and EMA (threshold 80% completion) and responses to usability questionnaires at week 1 and 4 to provide feedback on comfort, usability and engagement. The score ranges from 10 to 50, higher score indicating a better usability.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jun 2020
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthMode Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413851
- Sponsor's protocol ID
- HM060401
- Status last verified
- Dec 2021
- First submitted
- 29 May 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Passive Collection of Activity Data in Subjects With Agitation in the Context of Dementia
- ClinicalTrials.gov ID
- NCT04413851
- Acronym / sponsor ID
- HM060401
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia, Frontotemporal Dementia, Lewy Body Dementia, Mixed Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HealthMode Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 4 Jun 2020 (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.
This is a multi-center, observational, feasibility study, to evaluate long term passive data collection, data quality, and user experience of HealthMode Agitation (Apps) to collect motion, location, physiological, and audio data; and eCOA and EMA responses with mobile devices (iPhone, Apple Watch).
The purpose of this study is to evaluate and improve HealthMode Apps data collection and usability in subjects experiencing agitation in the context of dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | –Subjects with a diagnosis of dementia who are experiencing agitation severe enough that it interferes with activities of daily living or social interaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible individuals who have a diagnosis of dementia and a recent history of agitation will sign an informed consent, with a legally authorized representative (LAR) when necessary, to enroll in the study.
Key inclusion criteria (9 listed)
- Male and female subjects 18 years and older.
- Subjects who have met DSM-5 criteria for Dementia (all cause)
- Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.
- Subjects resident in a group home, nursing home, or assisted living are eligible to participate.
- Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)
Key exclusion criteria (3 listed)
- Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.
- Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of passive and continuous data collection
Time frame: 28 days
Total time and percentage of continuous data collection for each stream of data aiming for >50% coverage.
1 secondary outcome
Tolerability of carrying a smartphone and wearing a data collection sensor on the wrist and/or hand in a population of subjects who may have frequent episodes of agitation or impulsive behavior.
Time frame: 28 days
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 17 Dec 2021.
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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.
2 sites 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 Alzheimer Disease, run by HealthMode Inc. at 2 sites 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 9 inclusion and 3 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 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Feasibility of passive and continuous data collection (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2021.