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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

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.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Arthritis, Rheumatoid Other: Incentive Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Percentage of Days Goal Met [ Time Frame: 12 Weeks ]
    The primary outcome will be percent of days meeting goal during the intervention period


Secondary Outcome Measures :
  1. RAPID3 [ Time Frame: 26 Weeks ]
    Comparison of RAPID3 score and amount of physical activity

  2. Psoriasis [ Time Frame: 26 Weeks ]
    Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.

  3. Patient Feedback [ Time Frame: 14 Weeks and 26 Weeks ]
    Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26

  4. Sleep Disturbance and Fatigue [ Time Frame: 26 Weeks ]
    Changes in sleep disturbance and fatigue as determined by PROMIS forms.

  5. Completion of Activities by Study Participants (Feasibility) [ Time Frame: 26 Weeks ]
    Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Alexis Ogdie-Beatty, MD, MSCE University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02912221    
Other Study ID Numbers: 825214
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases