Dementia, MildNCT06417333
A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms
A study testing xiaomi mi band 7 smart wristband in people with Dementia, Mild, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Mild
- What is being tested?
- xiaomi mi band 7 smart wristband
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Apr 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Older patients who are willing to wear a smart wristband and have an Android smart phone
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman University - Dementia Clinic
Muğla
About this study
In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech
Read the detailed description
3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database.
The data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices.
Mobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them.
MMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information
- Conditions
- Dementia, Mild
- Being tested
- xiaomi mi band 7 smart wristband
- Keywords
- dementia health data fitness tracking
- Medical subject headings
- Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xiaomi mi band 7 smart wristbandDevice
Patients with mild dementia have been distributed xiaomi mi band 7 smart wristbands for health data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period
The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, minimum is 0. A score of 24 or lower is indicative of cognitive impairment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Sep 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, MildStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 2 15 people groups were distributes wristbands during a 6 month span
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baris Ceyhan, Muğla Sıtkı Koçman University
- Investigators
- Tugba Suzek, Dr., Study chair, Head of The Bioinformatics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417333
- Sponsor's protocol ID
- 230086
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms
- ClinicalTrials.gov ID
- NCT06417333
- Acronym / sponsor ID
- 230086
- Conditions
- Dementia, Mild
- Keywords
- dementia health data fitness tracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 16 May 2024 (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.
In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech
Detailed description
3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database.
The data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices.
Mobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them.
MMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- 2 15 people groups were distributes wristbands during a 6 month span
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Older patients who are willing to wear a smart wristband and have an Android smart phone
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| xiaomi mi band 7 smart wristbandPatients with mild dementia have been distributed xiaomi mi band 7 smart wristbands for health data collection | Device | – |
Primary outcome
Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period
Time frame: 3 months
The Mini Mental State Examination (MMSE) is a tool that can be used to systematically and thoroughly assess mental status. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30, minimum is 0. A score of 24 or lower is indicative of cognitive impairment.
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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
Tugba Suzek, Dr. study chair
Head of The Bioinformatics Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xiaomi mi band 7 smart wristband in people with Dementia, Mild, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 1 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 16 May 2024. 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 Turkey (Türkiye). 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?
Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period (time frame: 3 months). 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 16 May 2024.