A Novel Smartphone Application for "Smart" Trials

NCT ID: NCT04052282

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-03

Study Completion Date

2021-08-01

Brief Summary

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The overarching goal is to develop a mHealth App that can use smartphone embedded sensors to objectively collect physical function data in healthy individuals in the context of daily life.

Detailed Description

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The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect physical function data in healthy individuals in the context of daily life. The investigators will perform technical development of an internet-interactive App to collect, analyze and transfer the subjects' data. As a proof-of-concept, the mHealth App will execute algorithms that automate deployment of three well-established physical function tests. In a laboratory setting, it will be evaluated usability, acceptability and reliability of the mHealth App compared with traditional performance tests among focus groups. The investigators will then evaluate its usability and acceptability when used in the participants' home environments.

Conditions

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Healthy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Mobile Health App - Healthy Individuals

Mobile health App - Test

Beta Testing 1: The Beta test 1 will be performed with participants inside the Research Center. The purpose of this phase is to increase usability, acceptability and reliability of the mHealth App in participants.

Beta Testing 2: The Beta test 2 will be performed with patients outside the Research Center, at their houses. The purpose is to focus on the mHealth App remote usability, acceptability, and data collection.

Mobile Health App

Intervention Type DEVICE

There is no intervention

Interventions

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Mobile Health App

There is no intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects at least 50 years old with symptomatic knee osteoarthritis
* English Speaker
* Be able to walk 20 meters without an assistive device, such as a cane, walker or crutches.
* Have an iPhone 6 or higher with internet connection.

Exclusion Criteria

* Prior surgery on either knee within 6 months of enrollment
* Received corticosteroid injection in the knee within 3 months of enrollment
* Evidence or history of knee disease or trauma
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

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Lucas Ogura Dantas

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lucas O Dantas, PT

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

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Federal University of São Carlos

São Carlos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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IRB #:13237

Identifier Type: -

Identifier Source: org_study_id

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