A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms

Dementia, Mild Clinical Trial

Official title:

A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06417333
• Other study ID #: 230086
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the patient using speech

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Older patients who are willing to wear a smart wristband and have an Android smart phone

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Dementia
• Dementia, Mild

Intervention

Device:
• xiaomi mi band 7 smart wristband
Patients with mild dementia have been distributed xiaomi mi band 7 smart wristbands for health data collection

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University - Dementia Clinic	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months