Scleroderma
Conditions
Keywords
Systemic Sclerosis
Brief summary
The researchers seek to understand if the Resilience-based, Energy Management to Enhance Wellbeing and Fatigue (RENEW) program helps with scleroderma symptom management and disease burden. The researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.
Interventions
BEHAVIORALRENEW
RENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being.
Sponsors
Rheumatology Research Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants and study team member who randomizes participants are blinded to participant responses at randomization. However, following assignment the blind is broken.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of Systemic Sclerosis (SSc), any subtype * Report a mean score of at least 4 on the Fatigue Severity Scale; potential mean range 1-9 * Have access to a computer and an internet connection * Are able to speak and read English.
Exclusion criteria
* Currently undergoing structured rehabilitation or psychological treatment. * Other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access RENEW intervention, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue | Up to 12 weeks | Fatigue is measured by The Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue 13a. FACIT is a questionnaire with 13 questions and a score ranging from 13-65. Higher scores indicate greater fatigue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Interference | Up to 12 weeks | Pain interference is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference 4a scale Pain Interference 4a will assess self-reported consequences of pain with 4 questions ranked on a 5-point scale, from not at all to very much. The minimum score is 4 and the maximum score is 20. Lower scores suggest less pain interference. |
| Change in Resilience | Up to 12 weeks | Resilience is measured by Connor-Davidson Resilience Scale 10 (CD-RISC-10). It is a 10 item self-report rating scale 0 (not true at all) to 4 (true nearly all the time). The overall score range from 0 (no resilience) to 40 (High Resilience). |
| Change in Depressive symptoms | Up to 12 weeks | Depressive symptoms are measured by PROMIS depression 4a assesses self-reported negative mood (e.g., sadness), views of self (e.g., worthlessness), social cognition (e.g., loneliness), and decreased positive affect and engagement. Items are all answered on a 5-point scale from 1=Never to 5=Always. Scores can range from 0 meaning no anxiety/depression to 40 meaning high |
Countries
United States
Outcome results
None listed