Back to resultsTaking Charge of Systemic Sclerosis (TOSS)
Primary Purpose
Scleroderma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internet-based self-management program
Scleroderma book
Sponsored by
About this trial
This is an interventional other trial for Scleroderma focused on measuring systemic sclerosis, ssc
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Internet-based self-management program
Education book group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).
Change in Confidence in Self Management on the Patient Activation Measure Scale
The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full "activated".
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
Managing Daily Activities 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.
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
Managing Emotions 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.
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
Managing Medication and Treatment 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.
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
Managing Social Interactions 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.
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents better physical function, a lower score represents poorer physical function.
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents better social role functioning and a lower score represents poorer social role functioning.
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain.
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Full Information
NCT ID
NCT02494401
First Posted
May 22, 2015
Last Updated
August 19, 2019
Sponsor
University of Michigan
Collaborators
University of New Mexico, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02494401
Brief Title
Taking Charge of Systemic Sclerosis
Acronym
TOSS
Official Title
Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2016 (Actual)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
University of New Mexico, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
Keywords
systemic sclerosis, ssc
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based self-management program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Education book group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Internet-based self-management program
Intervention Type
Other
Intervention Name(s)
Scleroderma book
Primary Outcome Measure Information:
Title
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
Description
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.
Time Frame
Baseline compared with 16 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
Description
EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).
Time Frame
Baseline compared with 16 weeks, 6 months
Title
Change in Confidence in Self Management on the Patient Activation Measure Scale
Description
The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full "activated".
Time Frame
Baseline compared with 16 weeks, 6 months
Title
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
Description
The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.
Time Frame
Baseline compared with 16 weeks, 6 months
Title
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
Description
Managing Daily Activities 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.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
Description
Managing Emotions 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.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
Description
Managing Medication and Treatment 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.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
Description
Managing Social Interactions 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.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents better physical function, a lower score represents poorer physical function.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents better social role functioning and a lower score represents poorer social role functioning.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), 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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain.
Time Frame
Baseline compared to 16 weeks and 6 months
Title
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Description
Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),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. A higher score represents worse symptomatology, a lower score represents better symptomatology.
Time Frame
Baseline compared to 16 weeks and 6 months
Other Pre-specified Outcome Measures:
Title
Change in PHQ-8
Description
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item questionnaire that is commonly used to measure depressive symptoms. A score of ≥10 is consistent with depressed mood with a score ranging from 0 to 24.
Time Frame
Baseline compared to 16 weeks and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Poole
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dinesh Khanna
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Silver
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34337153
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.
Results Reference
derived
PubMed Identifier
29741230
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.
Results Reference
derived
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Taking Charge of Systemic Sclerosis
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