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

May 11, 2024 updated by: Baris Ceyhan, Muğla Sıtkı Koçman University
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

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mugla, Turkey
        • Mugla Sitki Kocman University - Dementia Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Tugba Suzek, Dr., Head of The Bioinformatics Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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