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Stepping Up For Inflammatory Arthritis

NCT ID: NCT02912221

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2019-11-24

Brief Summary

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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

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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

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Arthritis, Psoriatic Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Incentive

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

Group Type ACTIVE_COMPARATOR

Incentive

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexis Ogdie-Beatty, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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825214

Identifier Type: -

Identifier Source: org_study_id