Clinical trial NCT04051489: A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials
Official title: Test-retest Reliability and Validity of and a Novel Smartphone Application to Objectively Measure Physical Function in Individuals With Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Chronic Diseaase
Technology
Pain
Function
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
Collaborators: name: Tufts Medical Center
First posted: 2019-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes subjects who are greater than 50 years old and meet the ACR criteria for knee osteoarthritis.

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.

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).

Primary outcomes:
measure: Numeric Rating Scale - TEST RETEST (clinical setting)
timeFrame: Day 1
measure: Numeric Rating Scale - TEST RETEST (clinical setting)
timeFrame: 7 days after day 1
measure: Numeric Rating Scale - DIURNAL CHANGE (home setting)
timeFrame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
measure: The Get up and Go - TEST RETEST (clinical setting)
timeFrame: Day 1
measure: The Get up and Go - TEST RETEST (clinical setting)
timeFrame: 7 days after day 1
measure: The Get up and Go - DIURNAL CHANGE (home setting)
timeFrame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
measure: The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
timeFrame: Day 1
measure: The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
timeFrame: 7 days after day 1
measure: The 30 Seconds Sit to Stand - DIURNAL CHANGE (home setting)
timeFrame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
measure: The 20-meter Walk - TEST RETEST (clinical setting)
timeFrame: Day 1
measure: The 20-meter Walk - TEST RETEST (clinical setting)
timeFrame: 7 days after day 1
measure: The 20-meter Walk - DIURNAL CHANGE (home setting)
timeFrame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Federal University of São Carlos
state: São Paulo
Study officials:
affiliation: Universidade Federal de Sao Carlos
name: Lucas O Dantas, PT
role: PRINCIPAL_INVESTIGATOR
References: