N/A
N=50
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Sarcoidosis · Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT05230693 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Proportion of Participants Recruited — 25; 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sarcoidosis Patient Assessment and Resource Companion App (Behavioral); Enhanced Standard Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Recruited |
25; 25 | — |
| PRIMARY Number of Participants Who Complete the Study |
25; 24 | — |
| PRIMARY Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions |
10; 15 | — |
| PRIMARY Treatment Satisfaction |
60.4; 49.1 | — |
| SECONDARY Change in Sarcoidosis Associated Fatigue From Baseline to Month 6 |
-7.1; 0.4 | — |
| SECONDARY Changes in Self-Efficacy From Baseline to Month 3 |
10.6; 0.6 | — |
| SECONDARY Changes in Stress From Baseline to Month 6 |
-5.0; -1.2 | — |
| SECONDARY Changes in Autonomous Motivation |
— | — |
| SECONDARY Changes in Quality of Life |
11.7; 1.3 | — |
Summary
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.
Eligibility Criteria
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 )
Data sourced from ClinicalTrials.gov (NCT05230693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.