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Taking Charge of Systemic Sclerosis (TOSS)

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ClinicalTrials.gov Identifier: NCT02494401
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : August 9, 2017
Sponsor:
Collaborators:
University of New Mexico
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, 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.

Condition or disease Intervention/treatment Phase
Scleroderma Other: Internet-based self-management program Other: Scleroderma book Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Actual Study Start Date : March 6, 2016
Actual Primary Completion Date : July 28, 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Arm Intervention/treatment
Active Comparator: 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.
Other: Internet-based self-management program
Education book group
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



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

Secondary Outcome Measures :
  1. 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

  2. Quality of life on the European Quality of Life-5 Dimensions (EQ-5D) scale [ Time Frame: at least 6 months ]
  3. Confidence in Self Management on the Patient Activation Measure scale [ Time Frame: at least 6 months ]
  4. Appearance Satisfaction on the Satisfaction with Appearance Scale (SWAP) scale [ Time Frame: at least 6 months ]
  5. Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: at least 6 months ]
  6. Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: at least 6 months ]
  7. Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: at least 6 months ]
  8. Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 [ Time Frame: at least 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494401


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
University of New Mexico
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Janet Poole University of New Mexico
Principal Investigator: Dinesh Khanna University of Michigan
Principal Investigator: Richard Silver Medical University of South Carolina

Responsible Party: Dinesh Khanna, MD, MS, Dinesh Khanna, MD,MS, PI, University of Michigan
ClinicalTrials.gov Identifier: NCT02494401     History of Changes
Other Study ID Numbers: CER-1310-08323.
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Dinesh Khanna, MD, MS, University of Michigan:
systemic sclerosis
ssc

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases