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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| Medical University of South Carolina | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based self-management program | Other |
| ||
| Scleroderma book |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Confidence in Self Management on the Patient Activation Measure Scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Poole | University of New Mexico | Principal Investigator |
| Dinesh Khanna | University of Michigan | Principal Investigator |
| Richard Silver | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34337153 | Derived | 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. | |
| 29741230 | Derived |
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Participants completed baseline questionnaires. Participants were randomized to the intervention or control condition using a 1:1 ratio and computer-generated block randomization, and were stratified based on scores on the Patient Health Questionnaire-8 (<10, >10) in the baseline questionnaire.
Study recruitment occurred at two sites, The University of Michigan and the Medical University of South Carolina. Recruitment also took place utilizing social media, with the help of our patient partners and the Sclerderma Foundation and Scleroderma Research Foundation.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Internet-based self-management program |
| FG001 | 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. Scleroderma book |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Internet-based self-management program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | age at time of enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared with 16 weeks, 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Internet-based self-management program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Poole | University of New Mexico | (505) 272-1753 | JPoole@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2015 | Jun 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Other |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| BG001 | 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. Scleroderma book |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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). 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. | Mean | Standard Deviation | T-Score |
|
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale | The (EQ-5D) provides a generic health-related quality of life assessment. The 5 domains listed in each row are scored into 3 levels, level 1 (no problem), level 2 (some problems), level 3 (extreme problems). Visual analogue scale is a vertical scale with end points of 0 and 100, 0 corresponds to " the worst health you can imagine", and 100 corresponds to "the best health you can imagine". Using a conversion algorithm, the EQ-5D index patient responses are converted into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health). | Mean | Standard Deviation | units on a scale |
|
| 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.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 summed score is finally transformed into a 0-100 point scale with higher scores indicating more confidence and knowledge in patients managing their condition | Count of Participants | Participants |
|
| Appearance 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. | Mean | Standard Deviation | units on a scale |
|
| 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 daily actvities. | Mean | Standard Deviation | T-score |
|
| 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 emotions. | Mean | Standard Deviation | T-Score |
|
| 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 medications and treatments. | Mean | Standard Deviation | T-Score |
|
| 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 social interactions. | Mean | Standard Deviation | T Score |
|
| 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. | Mean | Standard Deviation | T Score |
|
| 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 worse symptomatology, a lower score represents better symptomatology. | Mean | Standard Deviation | T Score |
|
| 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. | Mean | Standard Deviation | T Score |
|
| 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. | Mean | Standard Deviation | T-Score |
|
| 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. | Mean | Standard Deviation | T-Score |
|
| 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). A raw score is created from each short form that makes up the Profile. To find the total raw score for a short form with all questions answered, sum the values of the response to each question within each domain. 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. | Mean | Standard Deviation | T-Score |
|
| 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® are scored as 0 being no pain and 10 being the worst imaginable pain. | Mean | Standard Deviation | T Score |
|
| 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. | Mean | Standard Deviation | T-score |
|
| PHQ-8 | The Patient Health Questionnaire-8 (PHQ-8) is an 8-item questionnaire that is commonly used to measure depressive symptoms. The minimum score is 0 with a maximum score of 24. A score of ≥10 is consistent with depressed mood, a score of ≥20 is consistent with severely depressed mood. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. Scleroderma book |
|
|
|
| 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). | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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". | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | PAM level | Baseline compared with 16 weeks, 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared with 16 weeks, 6 months |
|
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| Other Pre-specified | 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. | Population analyzed at 6 months differs due to drop outs shown in participant flow table. | Posted | Mean | Standard Deviation | units on a scale | Baseline compared to 16 weeks and 6 months |
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| 1 |
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | 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. Scleroderma book | 0 | 133 | 0 | 133 | 0 | 133 |
Not provided
Not provided
| 6 months |
|
|
p value 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.008 | p value 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.23 | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.6 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.56 | p value for 6 month comparison | Superiority |
| 6 months |
|
|
p value for 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.07 | p value for 6 month comparison | Superiority |
| 6 months |
|
|
p value for 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.23 | p value for 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.33 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.12 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.84 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.18 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.09 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.04 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.63 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.7 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.49 | p value of 6 month comparison | Superiority |
| 6 months |
|
|
p value of 16 week comparison |
| Superiority |
| Wilcoxon (Mann-Whitney) | 0.82 | p value of 6 month comparison | Superiority |