Taking Charge of Systemic Sclerosis

NCT ID: NCT02494401

Last Updated: 2019-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-06

Study Completion Date

2018-02-28

Brief Summary

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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 Description

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Conditions

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Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Internet-based self-management program

Intervention Type OTHER

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.

Group Type OTHER

Scleroderma book

Intervention Type OTHER

Interventions

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Internet-based self-management program

Intervention Type OTHER

Scleroderma book

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Dinesh Khanna, MD, MS

Dinesh Khanna, MD,MS, PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Janet Poole

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Dinesh Khanna

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Richard Silver

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34337153 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29741230 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CER-1310-08323.

Identifier Type: -

Identifier Source: org_study_id

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