Stepping Up For Inflammatory Arthritis (SUFIA)
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|ClinicalTrials.gov Identifier: NCT02912221|
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Psoriatic Arthritis, Rheumatoid||Other: Incentive||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis|
|Actual Study Start Date :||April 24, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
No Intervention: Control
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
An incentive will be used for this arm to encourage participants to meet their step goals
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.
- Percentage of Days Goal Met [ Time Frame: 12 Weeks ]The primary outcome will be percent of days meeting goal during the intervention period
- RAPID3 [ Time Frame: 26 Weeks ]Comparison of RAPID3 score and amount of physical activity
- Psoriasis [ Time Frame: 26 Weeks ]Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.
- Patient Feedback [ Time Frame: 14 Weeks and 26 Weeks ]Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26
- Sleep Disturbance and Fatigue [ Time Frame: 26 Weeks ]Changes in sleep disturbance and fatigue as determined by PROMIS forms.
- Completion of Activities by Study Participants (Feasibility) [ Time Frame: 26 Weeks ]Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912221
|United States, Pennsylvania|
|Hospital at the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Alexis Ogdie-Beatty, MD, MSCE||University of Pennsylvania|