Arthritis, PsoriaticSUFIANCT02912221
Stepping Up For Inflammatory Arthritis
A study testing Incentive in people with Arthritis, Psoriatic and Arthritis, Rheumatoid, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- What is being tested?
- Incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2017to 24 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
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.
Read the 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.
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- Being tested
- Incentive
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncentiveOther
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals |
| Incentive | Active comparator | An incentive will be used for this arm to encourage participants to meet their step goals Receives: Other: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Days Goal Met
The primary outcome will be percent of days meeting goal during the intervention period
Measured: 12 Weeks
Secondary outcomes (5)
RAPID3
Comparison of RAPID3 score and amount of physical activity
Measured: 26 Weeks
Psoriasis
Physician-assessed psoriasis severity as measured by body surface area (BSA) involved in patients with concurrent psoriasis.
Measured: 26 Weeks
Patient Feedback
Patient feedback as determined by qualitative surveys taken at Week 14 and Week 26
Measured: 14 Weeks and 26 Weeks
Sleep Disturbance and Fatigue
Changes in sleep disturbance and fatigue as determined by PROMIS forms.
Measured: 26 Weeks
Completion of Activities by Study Participants (Feasibility)
Percentage completion of study activities (weekly questionnaires and transmission of activity into Epic
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start24 Apr 2017
- Primary completion24 Oct 2019
- Study completion24 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexis Ogdie-Beatty, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912221
- Sponsor's protocol ID
- 825214
- Acronym
- SUFIA
- Status last verified
- Dec 2020
- First submitted
- 21 Sep 2016
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Increased Physical Activity on Patient Reported Measures of Disease Activity in Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT02912221
- Acronym / sponsor ID
- SUFIA / 825214
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 24 Oct 2019 (actual)
- Study completion
- 24 Nov 2019 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will be reimbursed for participation in the study but will not receive other encouragements for meeting fitbit and step count goals |
| Incentive | Active comparator | Other: IncentiveAn incentive will be used for this arm to encourage participants to meet their step goals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncentiveBoth 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. | Other | Incentive |
Primary outcome
Percentage of Days Goal Met
Time frame: 12 Weeks
The primary outcome will be percent of days meeting goal during the intervention period
5 secondary outcomes
RAPID3
Time frame: 26 Weeks
Psoriasis
Time frame: 26 Weeks
Patient Feedback
Time frame: 14 Weeks and 26 Weeks
Sleep Disturbance and Fatigue
Time frame: 26 Weeks
Completion of Activities by Study Participants (Feasibility)
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Ogdie-Beatty, MD, MSCE principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive in people with Arthritis, Psoriatic and Arthritis, Rheumatoid, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Days Goal Met (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.