SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
NCT ID: NCT05230693
Last Updated: 2025-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2022-02-23
2023-07-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SPARC Group
Sarcoidosis Patient Assessment and Resource Companion App
The first group, called the "SPARC group" will be asked to download the SPARC app onto the participant's smartphone, will be shown how to use the app, and then will be asked to use the app to do guided meditations for ten minutes twice a day
Enhanced Standard Care Control Group
Enhanced Standard Care
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Interventions
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Sarcoidosis Patient Assessment and Resource Companion App
The first group, called the "SPARC group" will be asked to download the SPARC app onto the participant's smartphone, will be shown how to use the app, and then will be asked to use the app to do guided meditations for ten minutes twice a day
Enhanced Standard Care
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Eligibility Criteria
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Inclusion Criteria
* ≥18 years old
* able to speak, hear, and understand English
* elevated SAF (FAS score ≥22)
* owns smartphone with current data plan
* willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)
Exclusion Criteria
* positive screening for potential major depression (Patient Health Questionnaire depression scale \[PHQ-8; α = .86\] score ≥10)
* untreated sleep apnea (based on home sleep study testing)
* sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications
* \>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)
* active substance abuse or binge drinking (\>21 drinks/week )
18 Years
ALL
No
Sponsors
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National Institute for Biomedical Imaging and Bioengineering (NIBIB)
NIH
Medical University of South Carolina
OTHER
Responsible Party
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W. Ennis James
Assistant Professor
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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00107105
Identifier Type: -
Identifier Source: org_study_id
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