Taking Charge of Systemic Sclerosis

Scleroderma Clinical Trial

— TOSS  

Official title:

Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494401
• Other study ID #: CER-1310-08323.
• Status: Completed
• Phase: N/A
• Start date: March 6, 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: February 2018
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis

Intervention

Other:
• Internet-based self-management program

• Scleroderma book

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	Medical University of South Carolina, Patient-Centered Outcomes Research Institute, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in PHQ-8	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.	Baseline compared to 16 weeks and 6 months
Primary	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	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).	Baseline compared with 16 weeks, 6 months
Secondary	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".	Baseline compared with 16 weeks, 6 months
Secondary	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.	Baseline compared with 16 weeks, 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months
Secondary	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.	Baseline compared to 16 weeks and 6 months