SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SPARC Group
|
Behavioral: 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
|
| Active Comparator: Enhanced Standard Care Control Group
|
Behavioral: Enhanced Standard Care
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
|
Outcome Measures
Primary Outcome Measures
- Proportion of Participants Recruited [Throughout the duration of the study, approximately 6 months]
Recruitment compared to number approached
- Number of participants who complete the study [Throughout the duration of the study, approximately 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 twice daily breathing awareness meditation sessions [Throughout the duration of the study, approximately 6 months]
Adherence is defined by participants completing 70% of the breathing awareness meditation sessions
- Number of participants who achieve treatment satisfaction [Throughout the duration of the study, approximately 6 months]
Treatment satisfaction is defined as providing an above average score on usability and satisfaction questionnaires (System Usability Scale >68, User Version of Mobile App Rating Scale >64, & Treatment Satisfaction Usability Scale >60)
Secondary Outcome Measures
- Change in Sarcoidosis Associated Fatigue [Week 0 and Week 24]
SAF is measured by Fatigue Assessment Scale which is a 10 item scale to assess for symptoms of chronic fatigue. A low score of 10 represents no fatigue and a high score of 50 represents severe fatigue.
- Changes in Self-Efficacy [Week 0 and Week 24]
Self-Efficacy is measured by the Fatigue Self-Efficacy Sale which is an 8 item scale to assess how the participant handles fatigue.
- Changes in Stress [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.
- 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.
- Changes in Quality of Life [Week 0 and Week 24]
Quality of life is measured by the 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Sarcoidosis diagnosis based on established criteria
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≥18 years old
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able to speak, hear, and understand English
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elevated SAF (FAS score ≥22)
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owns smartphone with current data plan
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willingness and ability to use app to engage in Breathing Awareness Meditation (BAM)
Exclusion Criteria:
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history of psychotic disorder, bipolar disorder, eating disorder, narcolepsy, cancer diagnosis or treatment in past 12 months
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positive screening for potential major depression (Patient Health Questionnaire depression scale [PHQ-8; α = .86] score ≥10)
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untreated sleep apnea (based on home sleep study testing)
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sarcoidosis exacerbation in past 3 months requiring increase in sarcoidosis medications
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2 hr travel distance to medical center (to reduce likelihood of no-show for focus groups)
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active substance abuse or binge drinking (>21 drinks/week )
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29403 |
Sponsors and Collaborators
- Medical University of South Carolina
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00107105
- 1R21EB025525