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Stepping Up For Inflammatory Arthritis (SUFIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912221
Recruitment Status : Active, not recruiting
First Posted : September 23, 2016
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE September 21, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE April 24, 2017
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
Percentage of Days Goal Met [ Time Frame: 12 Weeks ]
The primary outcome will be percent of days meeting goal during the intervention period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2016)
  • 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: 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.
  • Feasibility [ Time Frame: 26 Weeks ]
    Feasibility: completion of study activities (weekly questionnaires and transmission of activity into Epic).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stepping Up For Inflammatory Arthritis
Official Title  ICMJE Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
Intervention  ICMJE Other: Incentive
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.
Study Arms  ICMJE
  • 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
    Intervention: Other: Incentive
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02912221
Other Study ID Numbers  ICMJE 825214
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The investigators will share the results of the study after completion of the study through publication in a peer-reviewed journal. Investigators wishing to use the de-identified dataset for additional analyses can contact the PI after publication.
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP