A Novel Smartphone Application for "Smart" Knee Osteoarthritis Trials

Osteoarthritis, Knee Clinical Trial

Official title:

Test-retest Reliability and Validity of and a Novel Smartphone Application to Objectively Measure Physical Function in Individuals With Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051489
• Other study ID #: IRB #: 13237
• Status: Completed
• Start date: September 3, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: September 2021
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of São Carlos	São Carlos	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Tufts Medical Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scale - TEST RETEST (clinical setting)	A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.; A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.	Day 1
Primary	Numeric Rating Scale - TEST RETEST (clinical setting)	A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.; A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.	7 days after day 1
Primary	Numeric Rating Scale - DIURNAL CHANGE (home setting)	At home, a Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.A Numeric Rating Scale (NRS) will be applied to measure both knee pain. NRS is a well recognized tool to measure the intensity of pain that visually represents the intensity of pain that the individual believes to present. The scale will be displayed on the app and will have a range of 0 to 10, with 0 being the complete absence of pain and 10, the maximum intensity of pain reported by the individual.	Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
Primary	The Get up and Go - TEST RETEST (clinical setting)	In the clinical setting, the clinician asks the patient to stand up from a chair, walk 3 meters, turn around, return and sit back in the chair. The time on the test is used as a predictor of functional independence: below 20 seconds is considered normal and over 30 seconds as potentially indicative of increased risk for falls and functional dependence. For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters. After the test is completed, the data will be automatically sent to the cloud system.	Day 1
Primary	The Get up and Go - TEST RETEST (clinical setting)	In the clinical setting, the clinician asks the patient to stand up from a chair, walk 3 meters, turn around, return and sit back in the chair. The time on the test is used as a predictor of functional independence: below 20 seconds is considered normal and over 30 seconds as potentially indicative of increased risk for falls and functional dependence. For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters. After the test is completed, the data will be automatically sent to the cloud system.	7 days after day 1
Primary	The Get up and Go - DIURNAL CHANGE (home setting)	At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will pre-determine and tell the patient how many steps to take to achieve the distance of 3 meters. After the test is completed, the data will be automatically sent to the cloud system.	Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
Primary	The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)	In the clinical setting, the clinician asks the patient to sit in the middle of the chair, with the back straight, feet apart resting on the floor and in line with the shoulders. The patient has to rise from a sitting to a standing position as many times as possible in 30 seconds. With the results of this test, it is possible to evaluate a wide variety of skill levels, with scores ranging from 0 (for those unable to complete one repetition) to more than 20 repetitions (for the most physically fit individuals). For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period. After the test is completed, the data will be automatically sent to the cloud system.	Day 1
Primary	The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)	In the clinical setting, the clinician asks the patient to sit in the middle of the chair, with the back straight, feet apart resting on the floor and in line with the shoulders. The patient has to rise from a sitting to a standing position as many times as possible in 30 seconds. With the results of this test, it is possible to evaluate a wide variety of skill levels, with scores ranging from 0 (for those unable to complete one repetition) to more than 20 repetitions (for the most physically fit individuals). For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period. After the test is completed, the data will be automatically sent to the cloud system.	7 days after day 1
Primary	The 30 Seconds Sit to Stand - DIURNAL CHANGE (home setting)	At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a sitting position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically count the total sit to stand repetitions within a 30 seconds period. After the test is completed, the data will be automatically sent to the cloud system.	Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
Primary	The 20-meter Walk - TEST RETEST (clinical setting)	This test assesses gait speed and changes in patient's physical function over time. The clinician asks the patient to walk at a comfortable pace in a 20-meter unobstructed course and measures the time to perform the test. For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test. After the test is completed, the data will be automatically sent to the cloud system.	Day 1
Primary	The 20-meter Walk - TEST RETEST (clinical setting)	This test assesses gait speed and changes in patient's physical function over time. The clinician asks the patient to walk at a comfortable pace in a 20-meter unobstructed course and measures the time to perform the test. For the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test. After the test is completed, the data will be automatically sent to the cloud system.	7 days after day 1
Primary	The 20-meter Walk - DIURNAL CHANGE (home setting)	At home, for the automated test, the patient will wear a chest strap fixing the mobile phone over the sternum. On a standing position, the patient will open the mHealth App and through the use of audible feedback, will receive the same test instructions as in the clinic. With the use of algorithms, the mHealth App will automatically determine when the 20-meter distance is reached and will say to the patient to gradually stop, measuring the total time to complete the test. After the test is completed, the data will be automatically sent to the cloud system.	Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)