A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials

Universidade Federal de Sao Carlos

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Other: Mobile health App - Test

Study type: Observational

Funder types: Other

Identifiers

NCT04051489

IRB #: 13237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

20 participants in 1 patient group

Mobile App

Description:

Individuals with symptomatic knee osteoarthritis

Treatment:

Other: Mobile health App - Test