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Completed

NCT Number: NCT05230693

SPARC 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

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

Enhanced standard care

Behavioral

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

Primary outcomes

  1. Proportion of Participants Recruited

    Time frame: 6 months

    Recruitment compared to number approached

  2. Number of Participants Who Complete the Study

    Time frame: 6 months

    Participants complete the study in it's entirety and are able to use the app appropriately

  3. Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions

    Time frame: 3 months

    Adherence is defined by participants completing 70% of the breathing awareness meditation sessions

  4. Treatment Satisfaction

    Time frame: 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 outcomes

  1. Change in Sarcoidosis Associated Fatigue From Baseline to Month 6

    Time frame: 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)

  2. Changes in Self-Efficacy From Baseline to Month 3

    Time frame: 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.

  3. Changes in Stress From Baseline to Month 6

    Time frame: 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

  4. Changes in Autonomous Motivation

    Time frame: 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.

  5. Changes in Quality of Life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

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

Acronym: SPARC

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 9, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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