HealthyNCT04052282
A Novel Smartphone Application for "Smart" Trials
An observational study of Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mobile Health App
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Sep 2019to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes healthy subjects who are equal or greater than 50 years old.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Test-retest Reliability and Validity of and a Novel Smartphone Application to Objectively Measure Physical Function in Healthy Individuals
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.
Read the detailed description
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
- Healthy
- Being tested
- Mobile Health App
- Keywords
- Technology, Physical Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health AppDevice
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile Health App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: 7 days after day 1
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.
Measured: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
Measured: Day 1
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.
Measured: 7 days after day 1
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.
Measured: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
Measured: Day 1
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.
Measured: 7 days after day 1
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.
Measured: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
Measured: Day 1
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.
Measured: 7 days after day 1
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.
Measured: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start3 Sep 2019
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Tufts Medical Center
- Responsible party
- Principal investigator, Lucas Ogura Dantas, Universidade Federal de Sao Carlos
- Investigators
- Lucas O Dantas, PT, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052282
- Sponsor's protocol ID
- IRB #:13237
- Status last verified
- Sep 2021
- First submitted
- 5 Aug 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-retest Reliability and Validity of and a Novel Smartphone Application to Objectively Measure Physical Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04052282
- Acronym / sponsor ID
- IRB #:13237
- Conditions
- Healthy
- Keywords
- Technology, Physical Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Tufts Medical Center
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health App - Healthy Individuals | – | Device: Mobile Health AppMobile 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes healthy subjects who are equal or greater than 50 years old.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health AppThere is no intervention | Device | Mobile Health App - Healthy Individuals |
Primary outcome
Numeric Rating Scale - TEST RETEST (clinical setting)
Time frame: Day 1
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.
Numeric Rating Scale - TEST RETEST (clinical setting)
Time frame: 7 days after day 1
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.
Numeric Rating Scale - DIURNAL CHANGE (home setting)
Time frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
The Get up and Go - TEST RETEST (clinical setting)
Time frame: Day 1
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.
The Get up and Go - TEST RETEST (clinical setting)
Time frame: 7 days after day 1
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.
The Get up and Go - DIURNAL CHANGE (home setting)
Time frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
Time frame: Day 1
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.
The 30 Seconds Sit to Stand - TEST RETEST (clinical setting)
Time frame: 7 days after day 1
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.
The 30 Seconds Sit to Stand - DIURNAL CHANGE (home setting)
Time frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
The 20-meter Walk - TEST RETEST (clinical setting)
Time frame: Day 1
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.
The 20-meter Walk - TEST RETEST (clinical setting)
Time frame: 7 days after day 1
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.
The 20-meter Walk - DIURNAL CHANGE (home setting)
Time frame: Day 1, day 3, and day 5 (within a week Mon, Wed, Fri)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas O Dantas, PT principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale - TEST RETEST (clinical setting) (time frame: Day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.