SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Medical University of South Carolina50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoidosis Fatigue

Interventions

Sarcoidosis Patient Assessment and Resource Companion AppBEHAVIORAL

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 CareBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 )

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Proportion of Participants Recruited

Recruitment compared to number approached

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: Month 3

Secondary Outcomes

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)

Time frame: 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.

Data from ClinicalTrials.gov

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