Sarcoidosis is a systemic granulomatous inflammatory disease that disproportionately affects African Americans in the United States. Sarcoidosis associated fatigue (SAF) is reported by 80% of sarcoidosis patients (SPs) and is considered the most important predictor of quality of life (QoL) due to its negative effects on physical and psychological health. SPs experience significant stress, which has a strong association with increased fatigue and low quality of life. Mobile health technology-based (mHealth) stress management techniques including breathing awareness meditation (BAM) have been shown to reduce stress and fatigue and improve QoL in other chronic diseases. Besides our proof of concept trial, there have been no randomized controlled trials (RCTs) evaluating theory driven, tailored mHealth applications addressing SAF. In response to PA-18-389, the proposed R21will refine and test the Sarcoidosis Patient Assessment and Resource Companion (SPARC) app. SPARC includes multi-level components: 1) immediate physiological feedback of heart rate changes during BAM sessions, 2) objective indicator of BAM adherence via timestamp of heart rate data ,3) tailored text message delivered motivational feedback and reinforcement guided by self-determination theory and based upon adherence to daily BAM sessions, 4) healthcare provider & tech service phone access links and 5) automated summary reports to providers.
The aims are as follows:
Aim 1 : Develop and refine the SPARC App to assist SPs in coping with stress & SAF using BAM via further adaptation of Tension Tamer app (HL114957) using focus groups and post refinement lab based usability evaluations.
Aim 2 : Conduct a 12 week, 2-arm (SPARC vs. enhanced Standard Care) feasibility RCT in 50 SPs with SAF. Evaluations will occur at baseline, weeks 4 &12 and a post-trial follow-up at week 24. 2a: Primary outcomes of feasibility benchmarks: ? 80% recruitment, ?80 % retention rates & usability; ?.70 adherence to twice daily BAM sessions; ? 75 % of sample will score above average on usability & satisfaction questionnaires (SUS >68, uMARS >64& TSUQ >60). 2b: Secondary outcomes of changes in SAF, self-efficacy, stress, autonomous motivation, and QoL.
Aim 3 : Conduct focus groups after the SPARC trial with providers and staff (n=6-8) and with a random sample of SPARC users (n=12) to assess key user reactions including perceived acceptability, usability, salience, and identify sustainability facilitators/barriers. Triangulate data from AIMS 2 & 3 to further refine and optimize SPARC and prepare for a full-scale efficacy RCT. Long-term objective is to develop practical, effective and sustainable mHealth program for SAF. Dissemination of the SPARC App will help ameliorate the burden of SAF, decrease healthcare disparities, and improve QoL in SPs.
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.
