Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-30 @ 10:46 AM
Study NCT ID:
NCT05230693
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2022-01-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jamesw@musc.edu', 'phone': '843-792-3769', 'title': 'Ennis James, MD', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': "Patients were queried at month 0,1,3,6 regrading any perceived potential negative impact on the patient's health of using the smartphone app", 'eventGroups': [{'id': 'EG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants Recruited', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'OG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Recruitment compared to number approached', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Complete the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC App', 'description': 'Intervention group'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': "Participants complete the study in it's entirety and are able to use the app appropriately", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adherent', 'description': 'Patients in the SPARC App group that had 70% or better adherence to at least daily breathing awareness meditation'}, {'id': 'OG001', 'title': 'Nonadherent', 'description': 'Patients in the SPARC App group that were not adherent'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Adherence is defined by participants completing 70% of the breathing awareness meditation sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adherent', 'description': 'Patients in the SPARC App group that had 70% or better adherence to at least daily breathing awareness meditation'}, {'id': 'OG001', 'title': 'Nonadherent', 'description': 'Patients in the SPARC App group that were not adherent'}], 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': '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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Sarcoidosis Associated Fatigue From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'OG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 24', 'description': '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)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Self-Efficacy From Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC App', 'description': 'Intervention group'}, {'id': 'OG001', 'title': 'Enhanced Standard of Care', 'description': 'Control group'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '18.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 0 and Week 12', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Stress From Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'OG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 24', 'description': '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Autonomous Motivation', 'timeFrame': 'Week 0 and Week 24', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Changes in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'OG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 and Week 24', 'description': "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", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'FG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SPARC Group', 'description': 'Sarcoidosis Patient Assessment and Resource Companion App: 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'}, {'id': 'BG001', 'title': 'Enhanced Standard Care Control Group', 'description': 'Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Perceived Stress Scale (PSS-10)', 'classes': [{'categories': [{'measurements': [{'value': '19.9', 'spread': '7.0', 'groupId': 'BG000'}, {'value': '17.7', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '18.5', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0-40, lower score = lower stress', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fatigue Assessment Scale', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '30.8', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '30.8', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '0-50; higher scores = worse fatigue', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "King's Sarcoidosis Questionnaire", 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '47.6', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'QOL measure, range 0(poor)-100(better)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'includes all patients who completed at least 1 month of the study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-21', 'size': 593907, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-30T11:51', 'hasProtocol': True}, {'date': '2021-09-21', 'size': 2180745, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-25T15:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2022-01-25', 'resultsFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-23', 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Recruited', 'timeFrame': '6 months', 'description': 'Recruitment compared to number approached'}, {'measure': 'Number of Participants Who Complete the Study', 'timeFrame': '6 months', 'description': "Participants complete the study in it's entirety and are able to use the app appropriately"}, {'measure': 'Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions', 'timeFrame': '3 months', 'description': 'Adherence is defined by participants completing 70% of the breathing awareness meditation sessions'}, {'measure': 'Treatment Satisfaction', 'timeFrame': 'Month 3', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Change in Sarcoidosis Associated Fatigue From Baseline to Month 6', 'timeFrame': 'Week 0 and Week 24', 'description': '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)'}, {'measure': 'Changes in Self-Efficacy From Baseline to Month 3', 'timeFrame': 'Week 0 and Week 12', 'description': '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.'}, {'measure': 'Changes in Stress From Baseline to Month 6', 'timeFrame': 'Week 0 and Week 24', 'description': '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'}, {'measure': 'Changes in Autonomous Motivation', 'timeFrame': 'Week 0 and Week 24', 'description': '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.'}, {'measure': 'Changes in Quality of Life', 'timeFrame': 'Week 0 and Week 24', 'description': "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"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoidosis', 'Fatigue']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sarcoidosis diagnosis based on established criteria\n* ≥18 years old\n* able to speak, hear, and understand English\n* elevated SAF (FAS score ≥22)\n* owns smartphone with current data plan\n* willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)\n\nExclusion Criteria:\n\n* history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months\n* positive screening for potential major depression (Patient Health Questionnaire depression scale \\[PHQ-8; α = .86\\] score ≥10)\n* untreated sleep apnea (based on home sleep study testing)\n* sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications\n* \\>2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)\n* active substance abuse or binge drinking (\\>21 drinks/week )'}, 'identificationModule': {'nctId': 'NCT05230693', 'acronym': 'SPARC', 'briefTitle': 'SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue', 'orgStudyIdInfo': {'id': '00107105'}, 'secondaryIdInfos': [{'id': '1R21EB025525', 'link': 'https://reporter.nih.gov/quickSearch/1R21EB025525', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPARC Group', 'interventionNames': ['Behavioral: Sarcoidosis Patient Assessment and Resource Companion App']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Standard Care Control Group', 'interventionNames': ['Behavioral: Enhanced Standard Care']}], 'interventions': [{'name': 'Sarcoidosis Patient Assessment and Resource Companion App', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['SPARC Group']}, {'name': 'Enhanced Standard Care', 'type': 'BEHAVIORAL', 'description': 'Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.', 'armGroupLabels': ['Enhanced Standard Care Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'W. Ennis James', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}