Back to resultsSPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue (SPARC)
Primary Purpose
Sarcoidosis, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sarcoidosis Patient Assessment and Resource Companion App
Enhanced Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis
Eligibility Criteria
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 )
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SPARC Group
Enhanced Standard Care Control Group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of Participants Recruited
Recruitment compared to number approached
Number of participants who complete the study
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
Adherence is defined by participants completing 70% of the breathing awareness meditation sessions
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05230693
First Posted
January 25, 2022
Last Updated
July 31, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
1. Study Identification
Unique Protocol Identification Number
NCT05230693
Brief Title
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Acronym
SPARC
Official Title
The SPARC App: A Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
July 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPARC Group
Arm Type
Experimental
Arm Title
Enhanced Standard Care Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Sarcoidosis Patient Assessment and Resource Companion App
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Standard Care
Intervention Description
Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Primary Outcome Measure Information:
Title
Proportion of Participants Recruited
Description
Recruitment compared to number approached
Time Frame
Throughout the duration of the study, approximately 6 months
Title
Number of participants who complete the study
Description
Participants complete the study in it's entirety and are able to use the app appropriately
Time Frame
Throughout the duration of the study, approximately 6 months
Title
Number of participants who maintain adherence to twice daily breathing awareness meditation sessions
Description
Adherence is defined by participants completing 70% of the breathing awareness meditation sessions
Time Frame
Throughout the duration of the study, approximately 6 months
Title
Number of participants who achieve treatment satisfaction
Description
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)
Time Frame
Throughout the duration of the study, approximately 6 months
Secondary Outcome Measure Information:
Title
Change in Sarcoidosis Associated Fatigue
Description
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.
Time Frame
Week 0 and Week 24
Title
Changes in Self-Efficacy
Description
Self-Efficacy is measured by the Fatigue Self-Efficacy Sale which is an 8 item scale to assess how the participant handles fatigue.
Time Frame
Week 0 and Week 24
Title
Changes in Stress
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.
Time Frame
Week 0 and Week 24
Title
Changes in Autonomous Motivation
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.
Time Frame
Week 0 and Week 24
Title
Changes in Quality of Life
Description
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.
Time Frame
Week 0 and Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 )
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue
We'll reach out to this number within 24 hrs