Stepping Up For Inflammatory Arthritis

Study Overview
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Brief Summary
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This study will examine the benefits of a monitored physical activity program for participants with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) using a wearable activity device (e.g.fitbit). The goals of this pilot study are to examine 1) whether an incentive is better than no incentive in maintaining an increased level of physical activity and 2) the benefits of physical activity on patient reported disease activity in inflammatory arthritis.

Detailed Description
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Rheumatoid arthritis (RA) and psoriatic arthritis (PsA) are chronic, systemic inflammatory disorders affecting 1-2% of the US population. Ongoing chronic inflammation and lack of exercise due to arthritis are each associated with pain, fatigue, depression, muscle loss, obesity, and development of chronic diseases such as cardiovascular disease and diabetes, all of which impact physical functioning and quality of life. Increases in physical activity can significantly impact each one of these outcomes and are likely to positively impact a patients experience of their disease. This study will examine the benefits of a monitored physical activity program. This study will use a wearable activity device (e.g. fitbit) to monitor step counts and will incentivize one group to achieve higher step counts than the control group. The primary goal of this pilot study will be to determine whether one incentive (loss aversion) is better than no incentive in increasing step counts and maintaining an increased level of physical activity. Additional outcomes of interest are patient reported disease activity (using the RAPID3 patient reported outcome) and physician measured disease activity, quality of life assessments and weight loss.

Official Title
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Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis

Conditions
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Arthritis, Psoriatic, Arthritis, Rheumatoid

Intervention / Treatment
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* Other: Incentive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of RA or PsA by a rheumatologist Followed by a Penn rheumatologist Age 18-80 A RAPID3 score of 3 An active email account Owns a smart phone and able to download an application Willing to take internet based surveys weekly and allow data from a smart phone application to be uploaded Exclusion Criteria: Inability to walk or regular use of a wheel chair or assistive device (e.g., walker or cane) Hospitalization within the past 30 days Heart or lung disease that precludes participation in an exercise study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals | |
| Active Comparator: Incentive<br>An incentive will be used for this arm to encourage participants to meet their step goals | Other: Incentive<br>* Both groups will receive fitbits to track their physical activity, however one arm of the study may receive additional incentives to achieve their step count goal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days Goal Met | The primary outcome will be percent of days meeting goal during the intervention period | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAPID3 | Comparison of RAPID3 score and amount of physical activity | 26 Weeks | 
| Psoriasis | Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis. | 26 Weeks | 
| Patient Feedback | Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26 | 14 Weeks and 26 Weeks | 
| Sleep Disturbance and Fatigue | Changes in sleep disturbance and fatigue as determined by PROMIS forms. | 26 Weeks | 
| Completion of Activities by Study Participants (Feasibility) | Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic | 26 Weeks |