Taking Charge of Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management

Conditions
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Scleroderma

Intervention / Treatment
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* Other: Internet-based self-management program
* Other: Scleroderma book


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Internet-based self-management program<br>Internet-based self-management program Patients randomized to active treatment intervention will be assigned to the Internet program. The site will be accessed via secured website. The modules will be presented 1-2 per week and will be moderated by a researcher with expertise in moderating Discussion Boards. | Other: Internet-based self-management program<br> <br> |
| Other: Education book group<br>Educational book group. Participants in the control group will receive a copy of The Scleroderma Book: A Guide for Patients and Families, by Dr. Maureen Mayes. | Other: Scleroderma book<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline compared with 16 weeks, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Baseline compared with 16 weeks, 6 months | 
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline compared to 16 weeks and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic sclerosis, ssc