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Stepping Up For Inflammatory Arthritis (SUFIA)

Primary Purpose

Arthritis, Psoriatic, Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Incentive
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital at the University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Incentive

Arm Description

Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals

An incentive will be used for this arm to encourage participants to meet their step goals

Outcomes

Primary Outcome Measures

Percentage of Days Goal Met
The primary outcome will be percent of days meeting goal during the intervention period

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2016
Last Updated
December 4, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02912221
Brief Title
Stepping Up For Inflammatory Arthritis
Acronym
SUFIA
Official Title
Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
October 24, 2019 (Actual)
Study Completion Date
November 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic, Arthritis, Rheumatoid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals
Arm Title
Incentive
Arm Type
Active Comparator
Arm Description
An incentive will be used for this arm to encourage participants to meet their step goals
Intervention Type
Other
Intervention Name(s)
Incentive
Intervention Description
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 Measure Information:
Title
Percentage of Days Goal Met
Description
The primary outcome will be percent of days meeting goal during the intervention period
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
RAPID3
Description
Comparison of RAPID3 score and amount of physical activity
Time Frame
26 Weeks
Title
Psoriasis
Description
Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.
Time Frame
26 Weeks
Title
Patient Feedback
Description
Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26
Time Frame
14 Weeks and 26 Weeks
Title
Sleep Disturbance and Fatigue
Description
Changes in sleep disturbance and fatigue as determined by PROMIS forms.
Time Frame
26 Weeks
Title
Completion of Activities by Study Participants (Feasibility)
Description
Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis Ogdie-Beatty, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Stepping Up For Inflammatory Arthritis

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