SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Study Overview
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Brief Summary
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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.

Official Title
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The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Conditions
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Sarcoidosis, Fatigue

Intervention / Treatment
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* Behavioral: Sarcoidosis Patient Assessment and Resource Companion App
* Behavioral: Enhanced Standard Care


Participation Criteria
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Eligibility Criteria
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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 )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC Group<br> | Behavioral: Sarcoidosis Patient Assessment and Resource Companion App<br>* 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<br>|
| Active Comparator: Enhanced Standard Care Control Group<br> | Behavioral: Enhanced Standard Care<br>* Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Recruited | Recruitment compared to number approached | Throughout the duration of the study, approximately 6 months | 
| Number of participants who complete the study | Participants complete the study in it's entirety and are able to use the app appropriately | Throughout the duration of the study, approximately 6 months | 
| Number of participants who maintain adherence to twice daily breathing awareness meditation sessions | Adherence is defined by participants completing 70% of the breathing awareness meditation sessions | Throughout the duration of the study, approximately 6 months | 
| Number of participants who achieve treatment satisfaction | Treatment satisfaction is defined as providing an above average score on usability and satisfaction questionnaires (System Usability Scale >68, User Version of Mobile App Rating Scale >64, & Treatment Satisfaction Usability Scale >60) | Throughout the duration of the study, approximately 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sarcoidosis Associated Fatigue | SAF is measured by Fatigue Assessment Scale which is a 10 item scale to assess for symptoms of chronic fatigue. A low score of 10 represents no fatigue and a high score of 50 represents severe fatigue. | Week 0 and Week 24 | 
| Changes in Self-Efficacy | Self-Efficacy is measured by the Fatigue Self-Efficacy Sale which is an 8 item scale to assess how the participant handles fatigue. | Week 0 and Week 24 | 
| Changes in Stress | 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. | Week 0 and Week 24 | 
| Changes in Autonomous Motivation | 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. | Week 0 and Week 24 | 
| Changes in Quality of Life | Quality of life is measured by the 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. | Week 0 and Week 24 |