50 Participants Needed

SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

(SPARC Trial)

SP
Overseen BySamantha Pairet
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.

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.12345

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.13678

Are You a Good Fit for This Trial?

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
See 2 more

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)
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Standard Care
  • Sarcoidosis Patient Assessment and Resource Companion App
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: SPARC GroupExperimental Treatment1 Intervention
Group II: Enhanced Standard Care Control GroupActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Feasibility of a Comprehensive Home Monitoring Program for Sarcoidosis. [2020]
Prognostic features of sarcoidosis course in a Brazilian cohort. [2022]
Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue. [2023]
The Burden of Comorbidity and Complexity in Sarcoidosis: Impact of Associated Chronic Diseases. [2019]
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]
Validation of the Sarcoidosis Diagnostic Score in a Multicontinental Study. [2023]
CTAS: a CT score to quantify disease activity in pulmonary sarcoidosis. [2018]
Sarcoidosis: patient treatment priorities. [2023]
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