SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

NCT05230693 | Completed Results

• 2 other identifiers: 001071051R21EB025525
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis; Fatigue

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in Sarcoidosis Associated Fatigue From Baseline to Month 6

  Week 0 and Week 24

• Changes in Self-Efficacy From Baseline to Month 3

  Week 0 and Week 12

• Changes in Stress From Baseline to Month 6

  Week 0 and Week 24

• Changes in Autonomous Motivation

  Week 0 and Week 24

• Changes in Quality of Life

  Week 0 and Week 24

Study Arms (2)

SPARC Group

EXPERIMENTAL

Behavioral: Sarcoidosis Patient Assessment and Resource Companion App

Enhanced Standard Care Control Group

ACTIVE COMPARATOR

Behavioral: Enhanced Standard Care

Interventions

Sarcoidosis Patient Assessment and Resource Companion App BEHAVIORAL

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

SPARC Group

Enhanced Standard Care BEHAVIORAL

Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.

Enhanced Standard Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 )

Sponsors & Collaborators

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

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Fatigue

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ennis James, MD
• Organization: Medical University of South Carolina

jamesw@musc.edu

843-792-3769

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 9, 2022
• Study Start: February 23, 2022
• Primary Completion: December 22, 2022
• Study Completion: July 25, 2023
• Last Updated: April 6, 2025
• Results First Posted: July 25, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)