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SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Sarcoidosis
Fatigue

Treatments

Behavioral: Sarcoidosis Patient Assessment and Resource Companion App
Behavioral: Enhanced Standard Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05230693
1R21EB025525 (U.S. NIH Grant/Contract)
00107105

Details and patient eligibility

About

Fatigue is a pervasive and disabling symptom in sarcoidosis with limited treatment options. There is a significant association between heightened stress and sarcoidosis-associated fatigue. The proposed project will evaluate the usability/feasibility of a smartphone-based stress management application for the self-management of sarcoidosis-associated stress and fatigue.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Sarcoidosis diagnosis based on established 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

  • history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months
  • 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 )

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

SPARC Group
Experimental group
Treatment:
Behavioral: Sarcoidosis Patient Assessment and Resource Companion App
Enhanced Standard Care Control Group
Active Comparator group
Treatment:
Behavioral: Enhanced Standard Care

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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