Trial Outcomes & Findings for SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue (NCT NCT05230693)

Results Overview

Recruitment compared to number approached

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

6 months

Results posted on

2025-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	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	Enhanced Standard Care Control Group Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Overall Study STARTED	25	25
Overall Study COMPLETED	21	18
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SPARC Smartphone Application for the Management of Sarcoidosis-Associated Fatigue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPARC Group n=25 Participants 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 Control Group n=24 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.	Total n=49 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 14.2 • n=5 Participants	56.0 years STANDARD_DEVIATION 10.7 • n=7 Participants	54.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized African American	8 Participants n=5 Participants	14 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Perceived Stress Scale (PSS-10)	19.9 units on a scale STANDARD_DEVIATION 7.0 • n=5 Participants	17.7 units on a scale STANDARD_DEVIATION 6.9 • n=7 Participants	18.5 units on a scale STANDARD_DEVIATION 6.6 • n=5 Participants
Fatigue Assessment Scale	30.8 units on a scale STANDARD_DEVIATION 6.3 • n=5 Participants	30.8 units on a scale STANDARD_DEVIATION 7.1 • n=7 Participants	30.8 units on a scale STANDARD_DEVIATION 6.6 • n=5 Participants
King's Sarcoidosis Questionnaire	46.5 units on a scale STANDARD_DEVIATION 9.4 • n=5 Participants	47.8 units on a scale STANDARD_DEVIATION 10.7 • n=7 Participants	47.6 units on a scale STANDARD_DEVIATION 9.7 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Recruitment compared to number approached

Outcome measures

Outcome measures
Measure	SPARC Group n=25 Participants 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 Control Group n=25 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Proportion of Participants Recruited	25 Participants	25 Participants

PRIMARY outcome

Timeframe: 6 months

Participants complete the study in it's entirety and are able to use the app appropriately

Outcome measures

Outcome measures
Measure	SPARC Group n=25 Participants 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 Control Group n=24 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Number of Participants Who Complete the Study	25 Participants	24 Participants

PRIMARY outcome

Timeframe: 3 months

Adherence is defined by participants completing 70% of the breathing awareness meditation sessions

Outcome measures

Outcome measures
Measure	SPARC Group n=25 Participants 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 Control Group n=25 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Number of Participants Who Maintain Adherence to at Least Daily Daily Breathing Awareness Meditation Sessions	10 Participants	15 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	SPARC Group n=10 Participants 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 Control Group n=15 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Treatment Satisfaction	60.4 units on a scale Standard Deviation 16.4	49.1 units on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	SPARC Group n=21 Participants 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 Control Group n=25 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Change in Sarcoidosis Associated Fatigue From Baseline to Month 6	-7.1 units on a scale Standard Deviation 5.3	0.4 units on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SPARC Group n=25 Participants 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 Control Group n=24 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Changes in Self-Efficacy From Baseline to Month 3	10.6 score on a scale Standard Deviation 20.0	0.6 score on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SPARC Group n=25 Participants 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 Control Group n=18 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Changes in Stress From Baseline to Month 6	-5.0 units on a scale Standard Deviation 7.7	-1.2 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SPARC Group n=21 Participants 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 Control Group n=18 Participants Enhanced Standard Care: Participants will receive education about reducing fatigue associated with sarcoidosis during a normal clinic visit.
Changes in Quality of Life	11.7 units on a scale Standard Deviation 10.3	1.3 units on a scale Standard Deviation 9.6

Adverse Events

SPARC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Standard Care Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ennis James, MD

Medical University of South Carolina

Phone: 843-792-3769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place