Overview

This trial is active, not recruiting.

Condition scleroderma
Treatments internet-based self-management program, scleroderma book
Sponsor University of Michigan
Collaborator University of New Mexico
Start date March 2016
End date August 2017
Trial size 267 participants
Trial identifier NCT02494401, CER-1310-08323.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
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.
internet-based self-management program
(Other)
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.
scleroderma book

Primary Outcomes

Measure
Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
time frame: at least 6 months

Secondary Outcomes

Measure
Composite Outcome measure on the PROMIS® 29 profile v 2.0 scale
time frame: at least 6months
Quality of life on the European Quality of Life-5 Dimensions (EQ-5D) scale
time frame: at least 6 months
Confidence in Self Management on the Patient Activation Measure scale
time frame: at least 6 months
Appearance Satisfaction on the Satisfaction with Appearance Scale (SWAP) scale
time frame: at least 6 months
Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
time frame: at least 6 months
Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
time frame: at least 6 months
Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
time frame: at least 6 months
Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
time frame: at least 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Principal investigator Janet Poole
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Michigan.