A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials

NCT ID: NCT04051489

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-03
• Study Completion Date: 2021-08-01

Brief Summary

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

Detailed Description

The goal is to develop a mHealth App using smartphone embedded sensors to objectively collect physical function data in individuals with knee osteoarthritis (KOA) in the context of daily life. It will be performed 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 of individuals with KOA. It will then evaluate its usability and acceptability when used in the participants' home environments. As an early indicator of construct validity, it will be examined if the physical function test measurements can detect diurnal variation in the impact of KOA.

Conditions

Osteoarthritis, Knee

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Mobile App

Individuals with symptomatic knee osteoarthritis

Mobile health App - Test

Intervention Type: OTHER

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 with knee osteoarthritis (KOA).

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.

Interventions

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 with knee osteoarthritis (KOA).

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.

Intervention Type: OTHER

Eligibility Criteria

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. * Confirmation of knee osteoarthritis will be based on American College of Rheumatology (ACR) classification criteria:

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 any other inflammatory arthritis (rheumatoid arthritis, gout, psoriatic arthritis).

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role: lead

Responsible Party

Lucas Ogura Dantas

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas O Dantas, PT

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Federal University of São Carlos

São Carlos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

IRB #: 13237

Identifier Type: -

Identifier Source: org_study_id