Taking Charge of Systemic Sclerosis

Not Applicable

Completed

• Conditions: Scleroderma
• Interventions: Other: Scleroderma book; Other: Internet-based self-management program

• Registration Number: NCT02494401
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Start: 2016-03-06
• Primary Completion: 2017-07-28
• Study Completion: 2018-02
• Results First Submitted: 2018-10-09
• Results First Submitted QC: 2019-07-08
• Status Verified: 2019-08
• Results First Posted: 2019-08-15
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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

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Exclusion Criteria

• No computer access
• Inability to communicate in English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education book group	Scleroderma book	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.
Internet-based self-management program	Internet-based self-management program	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.

Primary Outcome Measures

Name	Time	Method
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8	Baseline compared with 16 weeks, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale	Baseline compared with 16 weeks, 6 months	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).
Change in Confidence in Self Management on the Patient Activation Measure Scale	Baseline compared with 16 weeks, 6 months	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".
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8	Baseline compared to 16 weeks and 6 months	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.
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8	Baseline compared to 16 weeks and 6 months	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.
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale	Baseline compared with 16 weeks, 6 months	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.
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8	Baseline compared to 16 weeks and 6 months	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.
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8	Baseline compared to 16 weeks and 6 months	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.
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure	Baseline compared to 16 weeks and 6 months	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States