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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
267
University of Michigan
Ann Arbor, Michigan, United States
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
Managing Symptoms score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time frame: Baseline compared with 16 weeks, 6 months
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).
Time frame: Baseline compared with 16 weeks, 6 months
Change in Confidence in Self Management on the Patient Activation Measure Scale
The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full "activated".
Time frame: Baseline compared with 16 weeks, 6 months
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.
Time frame: Baseline compared with 16 weeks, 6 months
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Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
Managing Daily Activities score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
Managing Emotions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
Managing Medication and Treatment score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
Managing Social Interactions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better physical function, a lower score represents poorer physical function.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better social role functioning and a lower score represents poorer social role functioning.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time frame: Baseline compared to 16 weeks and 6 months
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain.
Time frame: Baseline compared to 16 weeks and 6 months
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time frame: Baseline compared to 16 weeks and 6 months