N/A
Completed N=267
Taking Charge of Systemic Sclerosis
Scleroderma
Source: ClinicalTrials.gov NCT02494401 ↗
Enrolled (actual)
267
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 — 0.35; 0.94; 0.50; 1.49 units on a scale — p=0.87
Summary
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative educational book (Taking Charge of Systemic Sclerosis [TOSS]). During a 16-week comparative effectiveness 16-week randomized controlled trial, the investigators will recruit up to 250 patients who will be randomized to either TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and Families.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 |
0.35; 0.94; 0.50; 1.49 | 0.87 |
| SECONDARY Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale |
0.002; 0.02; 0.002; 0.04 | 0.08 |
| SECONDARY Change in Confidence in Self Management on the Patient Activation Measure Scale |
0.83; 0.98; 0.90; 1.70 | 0.68 |
| SECONDARY Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale |
0.82; 0.31; 0.18; 0.91 | 0.96 |
| SECONDARY Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 |
0.17; 0.79; 0.04; 0.48 | 0.89 |
| SECONDARY Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 |
0.09; 0.73; 0.71; 1.22 | 0.69 |
| SECONDARY Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 |
0.54; 0.70; 0.89; 0.49 | 0.28 |
| SECONDARY Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 |
0.43; 0.99; 0.40; 1.47 | 0.93 |
| SECONDARY Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
0.05; 0.75; 0.09; 1.08 | 0.59 |
| SECONDARY Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
2.05; 2.24; 1.19; 1.65 | 0.51 |
| SECONDARY Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
0.16; 0.86; 0.40; -1.14 | 0.83 |
| SECONDARY Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
0.08; 0.13; 0.61; -1.23 | 0.64 |
| SECONDARY Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
0.005; 0.20; 0.78; -1.36 | 0.73 |
| SECONDARY Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
-0.65; -0.80; -0.58; -1.03 | 0.95 |
| SECONDARY Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
0.11; 0.19; 0.02; -0.09 | 0.05 |
| SECONDARY Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure |
-2.95; -3.40; -1.30; -1.92 | 0.29 |
Eligibility Criteria
Inclusion Criteria
- All participants will be residents of the United States
- Diagnosed with systemic scleroderma,
- 18 years of age
- Possess basic computer literacy and have access to a computer with Internet and email capabilities
- Have the ability to communicate in English
Exclusion Criteria
- No computer access
- Inability to communicate in English
Data sourced from ClinicalTrials.gov (NCT02494401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.