SclerodermaTOSSNCT02494401
Taking Charge of Systemic Sclerosis
A study testing Internet-based self-management program and Scleroderma book in people with Scleroderma, run by University of Michigan at 1 site in United States.
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]). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma
- What is being tested?
- Internet-based self-management program and Scleroderma book
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No computer access
- Inability to communicate in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
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
- Being tested
- Internet-based self-management program, Scleroderma book
- Keywords
- systemic sclerosis, ssc
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-management programOther
Scleroderma bookOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Scleroderma book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline compared with 16 weeks, 6 months
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".
Measured: Baseline compared with 16 weeks, 6 months
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.
Measured: Baseline compared with 16 weeks, 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
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.
Measured: Baseline compared to 16 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study start6 Mar 2016
- Primary completion28 Jul 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Dinesh Khanna, MD, MS, University of Michigan
- Investigators
- Janet Poole, Principal investigator, University of New MexicoDinesh Khanna, Principal investigator, University of MichiganRichard Silver, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494401
- Sponsor's protocol ID
- CER-1310-08323.
- Acronym
- TOSS
- Status last verified
- Aug 2019
- First submitted
- 22 May 2015
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34337153Khanna 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.
PubMed 29741230
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Charge of Systemic Sclerosis: Improving Patient Outcomes Through Self-management
- ClinicalTrials.gov ID
- NCT02494401
- Acronym / sponsor ID
- TOSS / CER-1310-08323.
- Conditions
- Scleroderma
- Keywords
- systemic sclerosis, ssc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- University of New Mexico, Medical University of South Carolina, Patient-Centered Outcomes Research Institute
- Study start
- 6 Mar 2016 (actual)
- Primary completion
- 28 Jul 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 15 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-management program | Active comparator | Other: Internet-based self-management programInternet-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. |
| Education book group | Other | Other: Scleroderma bookEducational 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- No computer access
- Inability to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based self-management program | Other | Internet-based self-management program |
| Scleroderma book | Other | Education book group |
Primary outcome
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8
Time frame: Baseline compared with 16 weeks, 6 months
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.
15 secondary outcomes
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale
Time frame: Baseline compared with 16 weeks, 6 months
Change in Confidence in Self Management on the Patient Activation Measure Scale
Time frame: Baseline compared with 16 weeks, 6 months
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale
Time frame: Baseline compared with 16 weeks, 6 months
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8
Time frame: Baseline compared to 16 weeks and 6 months
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8
Time frame: Baseline compared to 16 weeks and 6 months
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure
Time frame: Baseline compared to 16 weeks and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34337153Murphy 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.
- Derived from this study: PubMed 29741230Khanna 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Poole principal investigator
University of New Mexico
Dinesh Khanna principal investigator
University of Michigan
Richard Silver principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based self-management program and Scleroderma book in people with Scleroderma, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 (time frame: Baseline compared with 16 weeks, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02494401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.