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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EB025525 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC Group | Experimental |
| |
| Enhanced Standard Care Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarcoidosis Patient Assessment and Resource Companion App | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Recruited | Recruitment compared to number approached | 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 | 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 | 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) | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Week 0 and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPARC Group | 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 |
| FG001 | Enhanced Standard Care Control Group | Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
includes all patients who completed at least 1 month of the study
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| ID | Title | Description |
|---|---|---|
| BG000 | SPARC Group | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants Recruited | Recruitment compared to number approached | Posted | Count of Participants | Participants | 6 months |
|
6 months
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SPARC Group | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ennis James, MD | Medical University of South Carolina | 843-792-3769 | jamesw@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2021 | Nov 30, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2021 | Jul 25, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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|
| Enhanced Standard Care | Behavioral | Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. |
|
| 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. | 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 | 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. | 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 | Week 0 and Week 24 |
| Enhanced Standard Care Control Group |
Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Perceived Stress Scale (PSS-10) | 0-40, lower score = lower stress | Mean | Standard Deviation | units on a scale |
|
| Fatigue Assessment Scale | 0-50; higher scores = worse fatigue | Mean | Standard Deviation | units on a scale |
|
| King's Sarcoidosis Questionnaire | QOL measure, range 0(poor)-100(better) | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Number of Participants Who Complete the Study | Participants complete the study in it's entirety and are able to use the app appropriately | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | Month 3 |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | Week 0 and Week 24 |
|
|
|
| Secondary | 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. | Posted | Median | Standard Deviation | score on a scale | Week 0 and Week 12 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Week 0 and Week 24 |
|
|
|
| Secondary | 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. | Not Posted | Week 0 and Week 24 | Participants |
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | Week 0 and Week 24 |
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|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Enhanced Standard Care Control Group | Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |