Clinical trial NCT02494401: Taking Charge of Systemic Sclerosis
Official title: Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Keywords: systemic sclerosis
ssc
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Medical University of South Carolina
name: Patient-Centered Outcomes Research Institute
First posted: 2015-07-10
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
timeFrame: Baseline compared with 16 weeks, 6 months
Secondary outcomes:
measure: Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
timeFrame: Baseline compared with 16 weeks, 6 months
measure: Change in Confidence in Self Management on the Patient Activation Measure Scale
timeFrame: Baseline compared with 16 weeks, 6 months
measure: Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
timeFrame: Baseline compared with 16 weeks, 6 months
measure: Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
measure: Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
timeFrame: Baseline compared to 16 weeks and 6 months
Other outcomes:
measure: Change in PHQ-8
timeFrame: Baseline compared to 16 weeks and 6 months
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of New Mexico
name: Janet Poole
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Dinesh Khanna
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Richard Silver
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.