SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Not Applicable

Completed

Conditions: Fatigue
Sarcoidosis

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

Registration Number: NCT05230693

Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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 )

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC Group	Sarcoidosis Patient Assessment and Resource Companion App	-
Enhanced Standard Care Control Group	Enhanced Standard Care	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions	3 months	Adherence is defined by participants completing 70% of the breathing awareness meditation sessions
Proportion of Participants Recruited	6 months	Recruitment compared to number approached
Number of Participants Who Complete the Study	6 months	Participants complete the study in it's entirety and are able to use the app appropriately
Treatment Satisfaction	Month 3	System Usability Scale (SUS) consists of ten statements each with five possible answers ranging from complete rejection to complete agreement. For each statement, the participant gives his or her approval or rejection in the form of a scale ranging from 1=strong approval to 5=strong rejection. The results of the SUS questionnaire are used to calculate a numerical value (SUS score). The results can have a value between 0 (worst application imaginable) and 100 (best application imaginable)

Secondary Outcome Measures

Name	Time	Method
Changes in Stress From Baseline to Month 6	Week 0 and Week 24	Stress is measured by the Perceived Stress Scale which is a 10 item scale that asks about feelings and thoughts during the last month. The scale ranges from 0-40, lower score meaning low stress, and a higher score meaning high stress. A negative change represents an improvement (decrease) in stress
Changes in Autonomous Motivation	Week 0 and Week 24	Autonomous motivation is measured by the Treatment Self-Regulation Questionnaire (TSRQ), which is a 15 item scale that assesses the degree of autonomous self-regulation to explain why participants engage or would engage in healthy behavior. The higher the score, the better the outcome.
Changes in Quality of Life	Week 0 and Week 24	Quality of life is measured by the King's Sarcoidosis Health Questionnaire (KSQ), which is a 29 item scale that asks the participant questions about their general health, lung health, medications, skin, and eyes. Reliability = .90 -.97. A positive change represents an improvement (increase) in QOL. range 0-100; positive number = improvement
Change in Sarcoidosis Associated Fatigue From Baseline to Month 6	Week 0 and Week 24	SAF is measured by Fatigue Assessment Scale which is a Fatigue Questionnaire (1 to 5-point scale x 10 questions for a total score range of 0 to 50) where a low value indicates less fatigued (better outcome) and a high value indicates more fatigued (worse outcome)
Changes in Self-Efficacy From Baseline to Month 3	Week 0 and Week 12	Self-Efficacy is measured by the Fatigue Self-Efficacy Sale which is an 8 item scale to assess how the participant handles fatigue. Scores range from 0 to 100, with higher scores representing better fatigue self-efficacy.