Sarcoidosis, Fatigue
Conditions
Brief 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. 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.
Interventions
BEHAVIORALSarcoidosis 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
BEHAVIORALEnhanced Standard Care
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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 )
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Recruited | 6 months | Recruitment compared to number approached |
| Number of Participants Who Complete the Study | 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 | 3 months | Adherence is defined by participants completing 70% of the breathing awareness meditation sessions |
| Treatment Satisfaction | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sarcoidosis Associated Fatigue From Baseline to Month 6 | Week 0 and Week 24 | 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) |
| Changes in Quality of Life | Week 0 and Week 24 | 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 |
| Changes in Self-Efficacy From Baseline to Month 3 | Week 0 and Week 12 | 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. |
| Changes in Stress From Baseline to Month 6 | Week 0 and Week 24 | 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 |
| Changes in Autonomous Motivation | Week 0 and Week 24 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Enhanced Standard Care Control Group Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit. | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Enhanced Standard Care Control Group | Total | SPARC Group |
|---|---|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 10.7 | 54.8 years STANDARD_DEVIATION 12.5 | 53.7 years STANDARD_DEVIATION 14.2 |
| Fatigue Assessment Scale | 30.8 units on a scale STANDARD_DEVIATION 7.1 | 30.8 units on a scale STANDARD_DEVIATION 6.6 | 30.8 units on a scale STANDARD_DEVIATION 6.3 |
| King's Sarcoidosis Questionnaire | 47.8 units on a scale STANDARD_DEVIATION 10.7 | 47.6 units on a scale STANDARD_DEVIATION 9.7 | 46.5 units on a scale STANDARD_DEVIATION 9.4 |
| Perceived Stress Scale (PSS-10) | 17.7 units on a scale STANDARD_DEVIATION 6.9 | 18.5 units on a scale STANDARD_DEVIATION 6.6 | 19.9 units on a scale STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized African American | 14 Participants | 22 Participants | 8 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 10 Participants | 26 Participants | 16 Participants |
| Sex: Female, Male Female | 14 Participants | 33 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants Who Complete the Study
Participants complete the study in it's entirety and are able to use the app appropriately
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPARC Group | Number of Participants Who Complete the Study | 25 Participants |
| Enhanced Standard Care Control Group | Number of Participants Who Complete the Study | 24 Participants |
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
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPARC Group | Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions | 10 Participants |
| Enhanced Standard Care Control Group | Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions | 15 Participants |
Primary
Proportion of Participants Recruited
Recruitment compared to number approached
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SPARC Group | Proportion of Participants Recruited | 25 Participants |
| Enhanced Standard Care Control Group | Proportion of Participants Recruited | 25 Participants |
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)
Time frame: Month 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPARC Group | Treatment Satisfaction | 60.4 units on a scale | Standard Deviation 16.4 |
| Enhanced Standard Care Control Group | Treatment Satisfaction | 49.1 units on a scale | Standard Deviation 15.1 |
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)
Time frame: Week 0 and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPARC Group | Change in Sarcoidosis Associated Fatigue From Baseline to Month 6 | -7.1 units on a scale | Standard Deviation 5.3 |
| Enhanced Standard Care Control Group | Change in Sarcoidosis Associated Fatigue From Baseline to Month 6 | 0.4 units on a scale | Standard Deviation 3.8 |
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.
Time frame: Week 0 and Week 24
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
Time frame: Week 0 and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPARC Group | Changes in Quality of Life | 11.7 units on a scale | Standard Deviation 10.3 |
| Enhanced Standard Care Control Group | Changes in Quality of Life | 1.3 units on a scale | Standard Deviation 9.6 |
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.
Time frame: Week 0 and Week 12
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| SPARC Group | Changes in Self-Efficacy From Baseline to Month 3 | 10.6 score on a scale | Standard Deviation 20 |
| Enhanced Standard Care Control Group | Changes in Self-Efficacy From Baseline to Month 3 | 0.6 score on a scale | Standard Deviation 18.8 |
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
Time frame: Week 0 and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SPARC Group | Changes in Stress From Baseline to Month 6 | -5.0 units on a scale | Standard Deviation 7.7 |
| Enhanced Standard Care Control Group | Changes in Stress From Baseline to Month 6 | -1.2 units on a scale | Standard Deviation 6.3 |