Osteoarthritis, KneeNCT02950090
MobilWise: Mobile Phone Remote Coaching After Worksite Joint ADventure Exposure
A study testing MobilWise and Fitbit Only in people with Osteoarthritis, Knee, run by Rush University Medical Center at 1 site in United States.
Trial summary
MobilWise, a worksite physical activity intervention for employees at high risk for knee osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a collaborating worksite to determine if remotely- coached physical activity counseling can increase and sustain physical activity in this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- MobilWise and Fitbit Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 30 Aug 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 y/o men and women after completion of the Joint ADventure intervention (included only overweight or obese persons over age 18 with chronic knee symptoms)
- naive to Joint ADventure (no Minimum BMI) but with knee symptoms of pain, aching or stiffness on most days over the past 3 months, and have the ability to ambulate at least household distances (50ft), the ability to speak and read English.
Who cannot join
- no primary diagnosis of fibromyalgia or inflammatory arthritis
- no co-morbidity that is more functionally limiting than the knee symptoms (e.g. spinal stenosis, peripheral vascular disease or residual effects of stroke)
- no co-morbid condition (based on medical history review) that contraindicates a physical activity intervention
- no total joint re- placement surgery within the past 1 year and no plans for total joint replacement in the next 12 months
- no plans to relocate away from the Chicago-land area in the next 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
MobilWise, a worksite physical activity intervention for employees at high risk for knee osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a collaborating worksite to determine if remotely- coached physical activity counseling can increase and sustain physical activity in this population. Knee osteoarthritis is a major public health problem and a leading cause of disability and work absenteeism/presenteeism in the US workforce. The overarching goal of this program is to develop and disseminate an affordable, efficient, efficacious physical activity intervention to large groups of employees at risk for knee OA. The Mobil Wise intervention is administered by health professionals, who will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via customized remote coach interface to 1) allow the remote coach to view and collect physical activity data generated by the personal monitor, and 2) use that data to formulate and provide tailored behavioral support, using motivational interviewing. This project has the potential to have a tremendous impact on improving symptoms and quality of life of persons with chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.
Read the detailed description
Because the US population is aging and obesity is rising dramatically, the epidemic of arthritis-associated disability and its associated costs will significantly worsen, largely due to the consequences of knee osteoarthritis (OA). Knee OA is already a major cause of work disability and work absenteeism/presenteeism, especially among obese and overweight employees. In addition, total knee replacement surgeries have increased by 161.5% among Medicare participants over the past 20 years and are expected to quadruple in the next 20 years. Increased physical activity can relieve the pain and activity limitations of individuals with knee OA, but this healthy lifestyle behavior has not been embraced by a substantial proportion of the employed population. The overarching goal of this program is to develop and disseminate an affordable, efficient, efficacious physical activity intervention that can assist large groups of employees with or at risk for knee OA to attain and maintain healthy physical activity behavior. MobilWise is a 12-week RCT pilot that will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via customized remote- coach interface to 1) allow a remote coach to view and collect physical activity data generated by the personal monitor, and 2) use that data to formulate and provide tailored behavioral support via mobile phone, ba sed on the supportive accountability model and using motivational interviewing. The MobilWise intervention will use the media communication mode preferred by the participant (text, voice call, or video chat) to attain and sustain healthy physical activity behavior in Blue Cross Blue Shield of Illinois employees with knee symptoms after previous completion of an in-person, intensive intervention (Joint ADventure). Six month follow-up measures are planned. Specific aims are to: 1) assess the feasibility of conducting a randomized controlled trial of the Mobil Wise intervention at this worksite, 2) estimate the effectiveness of the intervention to increase objectively-measured physical activity, 3) to develop/refine the customized remote coach-interface, dashboard, and coaching protocol, and 4) to examine the accuracy of the affordable personal monitor (Fitbit Flex) by comparing that output with data from the state-of-the-art GT3X+ accelerometer. This study leverages the combined clinical and technologic expertise of Northwestern's Arthritis Center Accelerometer Unit and its Center for Behavioral Intervention Technologies, in cooperation with the Fitbit technology team and the Blue Cross Blue Shield of Illinois Corporation. If successful, a multi-site randomized controlled trial/R01 proposal will follow to demonstrate the effectiveness/cost-effectiveness of the Mobil Wise intervention in larger worksite populations. Given the influence that BCBS has in shaping future health practices and the scalability/generalizability of the proposed intervention, this research could have a tremendous impact on improving symptoms and quality of life for those with early knee OA as well as preventing the work absenteeism/presenteeism, work disability, and increased healthcare costs associated with knee OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- MobilWise, Fitbit Only
- Keywords
- Knee symptoms, physical activity, Fitbit, Accelerometer, remote coaching
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MobilWiseBehavioural
see arm description for MobilWise above
Fitbit OnlyBehavioural
see arm description for Fitbit above
| Study group | Role | What they receive |
|---|---|---|
| MobilWise | Experimental | MobilWise will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via Fitabase to: allow a remote coach to view and collect physical activity data generated by the personal monitor, and use that data to formulate and provide tailored behavioral support, using motivational interviewing. The coach has a phone conversation weekly x 12 using motivational interviewing with participants to set goals and encourage activity. Coaches mention patient use of treatment elements (accountability) and will be positively reinforcing for adherent participants, or will include positive statements for those who are not adherent (supportive).Participants are also encouraged to use all the features of Fitbit (social networking, challenges, email reminders). Receives: Behavioral: MobilWise |
| Fitbit Only | Active comparator | will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) to monitor their own progress and physical activity level without coaching support. Participants are again encouraged to use all the features of Fitbit (social networking, challenges, email reminders) to achieve activity levels. Receives: Behavioral: Fitbit Only |
| Waitlist Control | No intervention | Participants in the waitlist arm have exposure to the usual wellness supports provided by the company: Motiva is the internal corporate wellness program that is under the direction of the Chief Medical Officer. Initiated in 2000, Motiva is staffed by two full- time health professionals and two full-time healthy lifestyle professionals. Motiva provides wellness programming year round on a BCBSIL intranet web page plus an individual page called myMotiva, where self- assessment of health risks, including weight and physical activity behavior, is encouraged. Participating in myMotiva allows individuals to earn up to $200 per year in an incentive program called Wellness Rewards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer counts/day;
Minutes of non-sedentary activity/day
Measured: change from baseline and 3 months
Accelerometer counts/day;
Minutes of non-sedentary activity/day;
Measured: change from baseline to 6 months
Accelerometer counts/day;
Minutes of non-sedentary activity/day
Measured: change from 3 months to 6 months
Secondary outcomes (1)
Fitbit measured physical activity
Minutes of non-sedentary activity/day
Measured: 6 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2015
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950090
- Sponsor's protocol ID
- R21AR065054-01
- Status last verified
- May 2018
- First submitted
- 24 Oct 2016
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MobilWise: Mobile Phone Remote Coaching After Worksite Joint ADventure Exposure
- ClinicalTrials.gov ID
- NCT02950090
- Acronym / sponsor ID
- R21AR065054-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee symptoms, physical activity, Fitbit, Accelerometer, remote coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 31 Oct 2016 (estimated)
- 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.
MobilWise, a worksite physical activity intervention for employees at high risk for knee osteoarthritis (OA), is being tested in a developmental randomized controlled trial at a collaborating worksite to determine if remotely- coached physical activity counseling can increase and sustain physical activity in this population. Knee osteoarthritis is a major public health problem and a leading cause of disability and work absenteeism/presenteeism in the US workforce. The overarching goal of this program is to develop and disseminate an affordable, efficient, efficacious physical activity intervention to large groups of employees at risk for knee OA. The Mobil Wise intervention is administered by health professionals, who will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via customized remote coach interface to 1) allow the remote coach to view and collect physical activity data generated by the personal monitor, and 2) use that data to formulate and provide tailored behavioral support, using motivational interviewing. This project has the potential to have a tremendous impact on improving symptoms and quality of life of persons with chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.
Detailed description
Because the US population is aging and obesity is rising dramatically, the epidemic of arthritis-associated disability and its associated costs will significantly worsen, largely due to the consequences of knee osteoarthritis (OA). Knee OA is already a major cause of work disability and work absenteeism/presenteeism, especially among obese and overweight employees. In addition, total knee replacement surgeries have increased by 161.5% among Medicare participants over the past 20 years and are expected to quadruple in the next 20 years. Increased physical activity can relieve the pain and activity limitations of individuals with knee OA, but this healthy lifestyle behavior has not been embraced by a substantial proportion of the employed population. The overarching goal of this program is to develop and disseminate an affordable, efficient, efficacious physical activity intervention that can assist large groups of employees with or at risk for knee OA to attain and maintain healthy physical activity behavior. MobilWise is a 12-week RCT pilot that will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via customized remote- coach interface to 1) allow a remote coach to view and collect physical activity data generated by the personal monitor, and 2) use that data to formulate and provide tailored behavioral support via mobile phone, ba sed on the supportive accountability model and using motivational interviewing. The MobilWise intervention will use the media communication mode preferred by the participant (text, voice call, or video chat) to attain and sustain healthy physical activity behavior in Blue Cross Blue Shield of Illinois employees with knee symptoms after previous completion of an in-person, intensive intervention (Joint ADventure). Six month follow-up measures are planned. Specific aims are to: 1) assess the feasibility of conducting a randomized controlled trial of the Mobil Wise intervention at this worksite, 2) estimate the effectiveness of the intervention to increase objectively-measured physical activity, 3) to develop/refine the customized remote coach-interface, dashboard, and coaching protocol, and 4) to examine the accuracy of the affordable personal monitor (Fitbit Flex) by comparing that output with data from the state-of-the-art GT3X+ accelerometer. This study leverages the combined clinical and technologic expertise of Northwestern's Arthritis Center Accelerometer Unit and its Center for Behavioral Intervention Technologies, in cooperation with the Fitbit technology team and the Blue Cross Blue Shield of Illinois Corporation. If successful, a multi-site randomized controlled trial/R01 proposal will follow to demonstrate the effectiveness/cost-effectiveness of the Mobil Wise intervention in larger worksite populations. Given the influence that BCBS has in shaping future health practices and the scalability/generalizability of the proposed intervention, this research could have a tremendous impact on improving symptoms and quality of life for those with early knee OA as well as preventing the work absenteeism/presenteeism, work disability, and increased healthcare costs associated with knee OA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MobilWise | Experimental | Behavioral: MobilWiseMobilWise will use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) via Fitabase to: allow a remote coach to view and collect physical activity data generated by the personal monitor, and use that data to formulate and provide tailored behavioral support, using motivational interviewing. The coach has a phone conversation weekly x 12 using motivational interviewing with participants to set goals and encourage activity. Coaches mention patient use of treatment elements (accountability) and will be positively reinforcing for adherent participants, or will include positive statements for those who are not adherent (supportive).Participants are also encouraged to use all the features of Fitbit (social networking, challenges, email reminders). |
| Fitbit Only | Active comparator | Behavioral: Fitbit Onlywill use data transmitted from an affordable accelerometer-based personal monitor (Fitbit Flex) to monitor their own progress and physical activity level without coaching support. Participants are again encouraged to use all the features of Fitbit (social networking, challenges, email reminders) to achieve activity levels. |
| Waitlist Control | No intervention | –Participants in the waitlist arm have exposure to the usual wellness supports provided by the company: Motiva is the internal corporate wellness program that is under the direction of the Chief Medical Officer. Initiated in 2000, Motiva is staffed by two full- time health professionals and two full-time healthy lifestyle professionals. Motiva provides wellness programming year round on a BCBSIL intranet web page plus an individual page called myMotiva, where self- assessment of health risks, including weight and physical activity behavior, is encouraged. Participating in myMotiva allows individuals to earn up to $200 per year in an incentive program called Wellness Rewards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 y/o men and women after completion of the Joint ADventure intervention (included only overweight or obese persons over age 18 with chronic knee symptoms)
- naive to Joint ADventure (no Minimum BMI) but with knee symptoms of pain, aching or stiffness on most days over the past 3 months, and have the ability to ambulate at least household distances (50ft), the ability to speak and read English.
Key exclusion criteria (5 listed)
- no primary diagnosis of fibromyalgia or inflammatory arthritis
- no co-morbidity that is more functionally limiting than the knee symptoms (e.g. spinal stenosis, peripheral vascular disease or residual effects of stroke)
- no co-morbid condition (based on medical history review) that contraindicates a physical activity intervention
- no total joint re- placement surgery within the past 1 year and no plans for total joint replacement in the next 12 months
- no plans to relocate away from the Chicago-land area in the next 12 months.
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 |
|---|---|---|
| MobilWisesee arm description for MobilWise above | Behavioural | MobilWise |
| Fitbit Onlysee arm description for Fitbit above | Behavioural | Fitbit Only |
Primary outcome
Accelerometer counts/day;
Time frame: change from baseline and 3 months
Minutes of non-sedentary activity/day
Accelerometer counts/day;
Time frame: change from baseline to 6 months
Minutes of non-sedentary activity/day;
Accelerometer counts/day;
Time frame: change from 3 months to 6 months
Minutes of non-sedentary activity/day
1 secondary outcome
Fitbit measured physical activity
Time frame: 6 months of study
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 24 May 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MobilWise and Fitbit Only in people with Osteoarthritis, Knee, run by Rush University Medical Center at 1 site in United States.
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 2 inclusion and 5 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 24 May 2018. 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 United States. 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?
Accelerometer counts/day; (time frame: change from baseline and 3 months). The study lists 3 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 24 May 2018.