SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Fatigue Clinical Trial

— SPARC  

Official title:

The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05230693
• Other study ID #: 00107105
• Secondary ID: 1R21EB025525
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: July 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 25, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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; a = .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 )

Related Conditions & MeSH terms

• Fatigue
• Sarcoidosis

Intervention

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
• Enhanced Standard Care
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Recruited	Recruitment compared to number approached	Throughout the duration of the study, approximately 6 months
Primary	Number of participants who complete the study	Participants complete the study in it's entirety and are able to use the app appropriately	Throughout the duration of the study, approximately 6 months
Primary	Number of participants who maintain adherence to twice daily breathing awareness meditation sessions	Adherence is defined by participants completing 70% of the breathing awareness meditation sessions	Throughout the duration of the study, approximately 6 months
Primary	Number of participants who achieve treatment satisfaction	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)	Throughout the duration of the study, approximately 6 months
Secondary	Change in Sarcoidosis Associated Fatigue	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.	Week 0 and Week 24
Secondary	Changes in Self-Efficacy	Self-Efficacy is measured by the Fatigue Self-Efficacy Sale which is an 8 item scale to assess how the participant handles fatigue.	Week 0 and Week 24
Secondary	Changes in Stress	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.	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.	Week 0 and Week 24
Secondary	Changes in Quality of Life	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.	Week 0 and Week 24