SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue (SPARC)

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

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.

Study Overview

• Status: Completed
• Conditions: Fatigue; Sarcoidosis
• Intervention / Treatment: Behavioral: Sarcoidosis Patient Assessment and Resource Companion App; Behavioral: Enhanced Standard Care

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPARC Group	Behavioral: 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
Active Comparator: Enhanced Standard Care Control Group	Behavioral: Enhanced Standard Care; Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Recruited	Recruitment compared to number approached	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	6 months
Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions	Adherence is defined by participants completing 70% of the breathing awareness meditation sessions	3 months
Treatment Satisfaction	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)	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Sarcoidosis Associated Fatigue From Baseline to Month 6	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)	Week 0 and Week 24
Changes in Stress From Baseline to Month 6	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	Week 0 and Week 24
Changes in Quality of Life	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	Week 0 and Week 24
Changes in Self-Efficacy From Baseline to Month 3	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.	Week 0 and Week 12

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Fatigue; Sarcoidosis
• Other Study ID Numbers: 00107105; 1R21EB025525 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No