Taking Charge of Systemic Sclerosis (TOSS)

University of Michigan

Status: Completed

Conditions: Scleroderma

Treatments: Other: Internet-based self-management program; Other: Scleroderma book

Study type: Interventional

Funder types: Other

Identifiers

NCT02494401

CER-1310-08323.

Details and patient eligibility

About

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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

Internet-based self-management program

Active Comparator group

Description:

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.

Treatment:

Other: Internet-based self-management program

Education book group

Other group

Description:

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.

Treatment:

Other: Scleroderma book