SarcoidosisSPARCNCT05230693
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
A study testing Sarcoidosis Patient Assessment and Resource Companion App in people with Sarcoidosis and Fatigue, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Fatigue
- What is being tested?
- Sarcoidosis Patient Assessment and Resource Companion App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2022to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: The SPARC App: A 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.
- Conditions
- Sarcoidosis, Fatigue
- Being tested
- Sarcoidosis Patient Assessment and Resource Companion App, Enhanced Standard Care
- Medical subject headings
- Sarcoidosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcoidosis Patient Assessment and Resource Companion AppBehavioural
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 CareBehavioural
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| SPARC Group | Experimental | Not described Receives: Behavioral: Sarcoidosis Patient Assessment and Resource Companion App |
| Enhanced Standard Care Control Group | Active comparator | Not described Receives: Behavioral: Enhanced Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Recruited
Recruitment compared to number approached
Measured: 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
Measured: 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
Measured: 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)
Measured: Month 3
Secondary outcomes (5)
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)
Measured: 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.
Measured: Week 0 and Week 12
Changes in Stress From Baseline to Month 6
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
Measured: Week 0 and Week 24
Changes in Autonomous Motivation
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.
Measured: Week 0 and Week 24
Changes in Quality of Life
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
Measured: Week 0 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start23 Feb 2022
- Primary completion22 Dec 2022
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, W. Ennis James, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230693
- Sponsor's protocol ID
- 00107105
- Other IDs
- 1R21EB025525
- Acronym
- SPARC
- Status last verified
- Mar 2025
- First submitted
- 25 Jan 2022
- Last updated
- 6 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
- ClinicalTrials.gov ID
- NCT05230693
- Acronym / sponsor ID
- SPARC / 00107105
- Conditions
- Sarcoidosis, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC Group | Experimental | Behavioral: Sarcoidosis Patient Assessment and Resource Companion App |
| Enhanced Standard Care Control Group | Active comparator | Behavioral: Enhanced Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcoidosis Patient Assessment and Resource Companion AppThe 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 | Behavioural | SPARC Group |
| Enhanced Standard CareParticipants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. | Behavioural | Enhanced Standard Care Control Group |
Primary outcome
Proportion of Participants Recruited
Time frame: 6 months
Recruitment compared to number approached
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
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
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)
5 secondary outcomes
Change in Sarcoidosis Associated Fatigue From Baseline to Month 6
Time frame: Week 0 and Week 24
Changes in Self-Efficacy From Baseline to Month 3
Time frame: Week 0 and Week 12
Changes in Stress From Baseline to Month 6
Time frame: Week 0 and Week 24
Changes in Autonomous Motivation
Time frame: Week 0 and Week 24
Changes in Quality of Life
Time frame: Week 0 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sarcoidosis Patient Assessment and Resource Companion App in people with Sarcoidosis and Fatigue, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Recruited (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.