Taking Charge of Systemic Sclerosis

NCT02494401 | Completed Results

• 1 other identifier: CER-1310-08323.
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma

Keywords

systemic sclerosis; ssc

Outcome Measures

Primary Outcomes (1)

• Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8

  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.

  Baseline compared with 16 weeks, 6 months

Secondary Outcomes (15)

• Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale

  Baseline compared with 16 weeks, 6 months

• Change in Confidence in Self Management on the Patient Activation Measure Scale

  Baseline compared with 16 weeks, 6 months

• Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale

  Baseline compared with 16 weeks, 6 months

• Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8

  Baseline compared to 16 weeks and 6 months

• Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8

  Baseline compared to 16 weeks and 6 months

Other Outcomes (1)

• Change in PHQ-8

  Baseline compared to 16 weeks and 6 months

Study Arms (2)

Internet-based self-management program

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.

Other: Internet-based self-management program

Education book group

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.

Other: Scleroderma book

Interventions

Internet-based self-management program OTHER

Internet-based self-management program

Scleroderma book OTHER

Education book group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will be residents of the United States
• Diagnosed with systemic scleroderma,
• 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

You may not qualify if:

• No computer access
• Inability to communicate in English

Sponsors & Collaborators

• University of Michigan: lead
• University of New Mexico: collaborator
• Medical University of South Carolina: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

• Murphy SL, Whibley D, Kratz AL, Poole JL, Khanna D. Fatigue Predicts Future Reduced Social Participation, not Reduced Physical Function or Quality of Life in People with Systemic Sclerosis. J Scleroderma Relat Disord. 2021 Jun 1;6(2):187-193. doi: 10.1177/2397198320965383. Epub 2020 Sep 20.

  PMID: 34337153 DERIVED

• Khanna D, Serrano J, Berrocal VJ, Silver RM, Cuencas P, Newbill SL, Battyany J, Maxwell C, Alore M, Dyas L, Riggs R, Connolly K, Kellner S, Fisher JJ, Bush E, Sachdeva A, Evnin L, Raisch DW, Poole JL. Randomized Controlled Trial to Evaluate an Internet-Based Self-Management Program in Systemic Sclerosis. Arthritis Care Res (Hoboken). 2019 Mar;71(3):435-447. doi: 10.1002/acr.23595. Epub 2019 Feb 5.

  PMID: 29741230 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Janet Poole
• Organization: University of New Mexico

JPoole@salud.unm.edu

(505) 272-1753

Study Officials

• Janet Poole

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Dinesh Khanna

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Richard Silver

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dinesh Khanna, MD,MS, PI

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: July 10, 2015
• Study Start: March 6, 2016
• Primary Completion: July 28, 2017
• Study Completion: February 1, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 15, 2019

Record last verified: 2019-08

Locations

US (1)