SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

(SPARC Trial)

Overseen By Samantha Pairet

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Psychotic disorder, Bipolar, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Enhanced Standard Care, Sarcoidosis Patient Assessment and Resource Companion App?

The SPARC App, part of the treatment, is expected to be a useful and feasible tool for improving fatigue and stress in sarcoidosis patients, as it provides self-management resources and breathing exercises that can be done at home, potentially overcoming barriers of traditional in-person programs. ^{1 2 3 4 5}

How does the Sarcoidosis Patient Assessment and Resource Companion App differ from other treatments for sarcoidosis?

The Sarcoidosis Patient Assessment and Resource Companion (SPARC) App is unique because it is a mobile health (mHealth) app specifically designed to help manage fatigue and stress in sarcoidosis patients through breathing awareness meditation and educational modules, offering a convenient alternative to in-person programs. ^{1 3 6 7 8}

What is the purpose of this trial?

This trial is testing a smartphone app designed to help sarcoidosis patients manage their stress, which may help reduce their fatigue.

Eligibility Criteria

Inclusion Criteria

You are willing and able to use a special app for Breathing Awareness Meditation (BAM).

Sarcoidosis diagnosis based on established criteria

able to speak, hear, and understand English

Exclusion Criteria

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)

>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a smartphone-based stress management application for self-management of sarcoidosis-associated stress and fatigue

6 months

Regular app usage and monitoring

Follow-up

Participants are monitored for changes in stress, motivation, and quality of life after treatment

4 weeks

Treatment Details

Interventions

• Enhanced Standard Care
• Sarcoidosis Patient Assessment and Resource Companion App

Participant Groups

Group I: SPARC Group Experimental Treatment 1 Intervention

Group II: Enhanced Standard Care Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Comprehensive Home Monitoring Program for Sarcoidosis. [2020]

2. Brazil pubmed.ncbi.nlm.nih.gov

Prognostic features of sarcoidosis course in a Brazilian cohort. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Burden of Comorbidity and Complexity in Sarcoidosis: Impact of Associated Chronic Diseases. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP): protocol for a multi-centre, longitudinal, observational study to identify clinical features that are predictive of sarcoidosis progression. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Validation of the Sarcoidosis Diagnostic Score in a Multicontinental Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

CTAS: a CT score to quantify disease activity in pulmonary sarcoidosis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Sarcoidosis: patient treatment priorities. [2023]