Impact of a resilience-building energy management intervention for people with systemic sclerosis: a mixed methods study.

Objectives: People with SSc often experience fatigue, which significantly affects daily life functioning and quality of life. We aimed to explore participants' experiences of a peer health-coached resilience-building energy management to enhance well-being (RENEW) intervention on symptoms and well-being and to use mixed methods to compare how SSc duration influenced the experiences of participants who had clinically significant fatigue improvement vs those who did not. Methods: Semi-structured interviews were conducted with 21 participants from the parent clinical trial randomized to the RENEW intervention. Data were analysed using the rigorous and accelerated data reduction technique combined with thematic content analysis. A mixed methods approach used a joint display to identify themes related to the impact of SSc duration on fatigue improvement status. Participants were categorized into short/improvement, short/limited improvement, long/improvement, and long/limited improvement. Results: Our team generated four themes: participant and peer health-coach relationship, physical and psychological well-being improvement, need for a tailored approach and easy program access through technology. Mixed methods analysis revealed that, regardless of SSc duration, participants with improved fatigue reported increasing self-awareness of SSc-related symptoms and learning coping strategies to manage fatigue. Participants in the short/improvement group reported preferences for slower pacing of the program and pairing with a coach with similar symptom severity. Participants in the long/limited improvement group sought SSc-specific symptom management information. Conclusion: Incorporating peer health coaches and technology is beneficial for self-management interventions for people with SSc. Future tailoring of RENEW based on SSc duration and symptom severity is needed. Clinical trial registration number: clinicatrials.gov, NCT04908943.

Effects of a Resilience-Building Energy Management Program on Fatigue and Other Symptoms in Systemic Sclerosis: A Randomized Controlled Trial.

OBJECTIVE: Supported self-management interventions for individuals with systemic sclerosis (SSc) are needed. We examined the effects of a 12-week resilience-building energy management program (called RENEW) for fatigue and other patient-reported outcomes. METHODS: Participants, who had physician-diagnosed SSc, moderate to severe fatigue, and were ≥18 years old, were randomly assigned to RENEW or waitlist control in a 2:1 ratio. The RENEW intervention included an educational website/application plus nine virtual peer-led health coaching sessions. The primary outcome was change in the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary outcomes were change in Patient Reported Outcomes Measurement Information System measures of pain interference and depressive symptoms and Connor-Davidson Resilience Scale. Outcomes were assessed at baseline, 6 weeks, and 12 weeks. Multiple imputation was conducted; linear mixed models were used to assess group differences. A three-way interaction with group, time, and SSc duration was examined in each model. RESULTS: Among 173 participants (mean ± SD age 54.5 ± 11.7 years; 93% female, 85% White), 47% had diffuse cutaneous SSc; 57% were ≤5 years from diagnosis. At 12 weeks, compared to controls, RENEW participants had a clinically meaningful fatigue improvement (ß = -4.7; 95% confidence interval -6.7 to -2.7; P < 0.001) and improvement in all secondary outcomes. Among RENEW participants, individuals with shorter disease duration had greater improvements in fatigue at 12 weeks. CONCLUSION: An mHealth supported self-management intervention improved fatigue and other outcomes, particularly in newly diagnosed patients. This program may be broadly scalable for SSc symptom management.

How do patients define Raynaud's phenomenon? Differences between primary and secondary disease.

INTRODUCTION/OBJECTIVES: To examine how people define Raynaud's phenomenon (RP) based on their lived experiences and explore if differences exist depending on primary or secondary RP diagnosis. METHOD: An international survey was sent to people with RP through health systems, foundations, and social media. Qualitative coding of responses to an open text question regarding one's own definition of RP was performed and themes were identified. The prevalence of themes among the sample and then comparisons between themes among people who self-reported primary versus secondary diagnosis of RP were performed. RESULTS: There were 1345 respondents from 45 countries (mean age 51.5 years, 93% female) who defined RP in their own words; 17% reported primary RP and 83% reported secondary RP (69% of secondary RP was scleroderma-related, n = 927). Over half defined their RP by describing the body parts affected, color changes, pain, and triggers or situations in which an episode occurs. Patients with primary RP more frequently defined RP in terms of its impact on function/quality of life and pain compared to those with secondary RP (34.5% versus 25.3%, respectively, p=0.004; 54.0% versus 46.8%, p=0.05). Patients with secondary RP more frequently included specific body parts, color change, the management of attacks, and other digital vascular complications in their definition of RP. CONCLUSIONS: We have identified differences in how people with primary and secondary RP define RP, in terms of how they feel and function. Our findings have implications for the domains of outcome measures for assessing RP within different patient populations. Key Points • Pain is more often mentioned in primary RP and color change in secondary RP. • Over 25% of patients included reduced the quality of life as part of their RP definition. • The concept of "attack" is used to define RP by only 2% of patients.

Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis.

OBJECTIVE: In a pilot study, our group showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the current study was to compare an internet-based self-management program to a patient-focused educational book developed to assess measures of self-efficacy and other patient-reported outcomes in patients with SSc. METHODS: We conducted a 16-week randomized, controlled trial. RESULTS: Of the 267 participants who completed baseline questionnaires and were randomized to the intervention (internet: www.selfmanagescleroderma.com) or control (book) group, 123 participants (93%) in the internet group and 124 participants (94%) in the control group completed the 16-week randomized controlled trial (RCT). The mean ± SD age of all participants was 53.7 ± 11.7 years, 91% were women, and 79.4% had some college or a higher degree. The mean ± SD disease duration after diagnosis of SSc was 8.97 ± 8.50 years. There were no statistical differences between the 2 groups for the primary outcome measure (Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms: mean change of 0.35 in the internet group versus 0.94 in the control group; P = 0.47) and secondary outcome measures, except the EuroQol 5-domain instrument visual analog scale score (P = 0.05). Internet group participants agreed that the self-management modules were of importance to them, the information was presented clearly, and the website was easy to use and at an appropriate reading level. CONCLUSION: Our RCT showed that the internet-based self-management website was not statistically superior to an educational patient-focused book in improving self-efficacy and other measures. The participants were enthusiastic about the content and presentation of the self-management website.