Clinical Trial: Taking Charge of Systemic Sclerosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University of Michigan

Current Primary Outcome: Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: at least 6 months ]

Original Primary Outcome: Confidence and Self Efficacy in the Managing Symptoms- PROMIS® Self-efficacy [ Time Frame: at least 6 montths ]

Current Secondary Outcome:

  • Composite Outcome measure on the PROMIS® 29 profile v 2.0 scale [ Time Frame: at least 6months ]
    Physical Function, Anxiety, Depression, Fatigue, Sleep disturbance,Ability to Participate in Social Roles and Activities, Pain interference and Pain Intensity
  • 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 ]


Original Secondary Outcome:

  • Compostie Outcome measure on the PROMIS® 29 profile v 2.0 scale [ Time Frame: at least 6months ]
    Function, Anxiety, Depression, Fatigue, Sleep disturbance, Pain and satisfaction with social roles
  • Quality of life in the European Quality of Life-5 Dimensions (EQ-5D) scale [ Time Frame: at least 6 months ]
  • Confidence in Self Management in the Patient Activation Measure scale [ Time Frame: at least 6 months ]
  • Appearance satisfaction in the Satisfaction with Appearance Scale (SWAP) scale [ Time Frame: at least 6 months ]


Information By: University of Michigan

Dates:
Date Received: May 22, 2015
Date Started: March 2016
Date Completion: November 2017
Last Updated: September 20, 2016
Last Verified: September 2016