Trial Outcomes & Findings for Evaluation of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together Program (NCT NCT04335279)

From April 9, 2020 to April 27, 2020, we recruited participants into a new SPIN COVID-19 Cohort internationally via social media announcements and from an existing systemic sclerosis cohort (the SPIN cohort). Ongoing SPIN Cohort participants were invited to enrol by email and via notices during regular SPIN Cohort assessments. Recruitment announcements were posted via social media and through patient organisation partners.

There were 560 eligible participants based on baseline questionnaires, of whom 246 indicated they were interested in participating in the trial; of these, 58 could not be reached to confirm enrolment and 16 were not randomly assigned owing to inability to match language or day and time availability. Thus, 172 were eligible and randomly assigned to intervention (n=86) or waitlist control (n=86). Of the 172, 93 (54%) were ongoing SPIN Cohort participants, and 79 (46%) were new participants.

Please note that for some participants, data was not available for some baseline characteristics

The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Raw scores are converted into T scores standardised in the US adult general population (mean=50, standard deviation=10). Higher scores represent more anxiety.

The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Raw scores are converted into T scores standardised in the US adult general population (mean=50, standard deviation=10). Higher scores represent more anxiety.

PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.

The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18 with higher scores indicating greater loneliness.

The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.

The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults. The unit of measure is MET(metabolic equivalent turnover)-minutes per week, which larger values meaning greater activity.

Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.

The COVID-19 Fears Questionnaire for Chronic Medical Conditions is a 10-item scale that ask participants to rate, on a typical day in the last week, how much they were afraid from "not at all" to "extremely" about aspects of COVID-19. Items are scored on a 5-point scale (range 1-5), total scores range from 10 to 50. Higher scores represent greater fear. The scale has been validated among people with scleroderma.