Trial Outcomes & Findings for Taking Charge of Systemic Sclerosis (NCT NCT02494401)

NCT ID: NCT02494401

Last Updated: 2019-08-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 267 participants
• Primary outcome timeframe: Baseline compared with 16 weeks, 6 months
• Results posted on: 2019-08-28

Participant Flow

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.

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.

Participant milestones

Measure	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	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
Overall Study STARTED	134	133
Overall Study Week 16	123	124
Overall Study 6 Month Follow up	109	106
Overall Study COMPLETED	109	106
Overall Study NOT COMPLETED	25	27

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	22	25
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Taking Charge of Systemic Sclerosis

Baseline characteristics by cohort

Measure	Internet-based Self-management Program n=134 Participants 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	Education Book Group n=133 Participants 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	Total n=267 Participants Total of all reporting groups
Age, Continuous	54.3 years STANDARD_DEVIATION 10.1 • n=5 Participants	52.9 years STANDARD_DEVIATION 13.1 • n=7 Participants	53.7 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	120 Participants n=7 Participants	243 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	102 Participants n=7 Participants	207 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	112 Participants n=5 Participants	109 Participants n=7 Participants	221 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	134 Participants n=5 Participants	133 Participants n=7 Participants	267 Participants n=5 Participants
Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8	47.41 T-Score STANDARD_DEVIATION 9.15 • n=5 Participants	47.58 T-Score STANDARD_DEVIATION 7.81 • n=7 Participants	47.50 T-Score STANDARD_DEVIATION 8.49 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Mobility	1.53 units on a scale STANDARD_DEVIATION 0.52 • n=5 Participants	1.61 units on a scale STANDARD_DEVIATION 0.49 • n=7 Participants	1.57 units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Self-Care	1.28 units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	1.79 units on a scale STANDARD_DEVIATION 0.49 • n=7 Participants	1.31 units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Usual Activities	1.78 units on a scale STANDARD_DEVIATION 0.50 • n=5 Participants	1.79 units on a scale STANDARD_DEVIATION 0.43 • n=7 Participants	1.79 units on a scale STANDARD_DEVIATION 0.46 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Pain Discomfort	1.93 units on a scale STANDARD_DEVIATION 0.48 • n=5 Participants	2.02 units on a scale STANDARD_DEVIATION 0.43 • n=7 Participants	1.98 units on a scale STANDARD_DEVIATION 0.46 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Anxiety	1.56 units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	1.63 units on a scale STANDARD_DEVIATION 0.62 • n=7 Participants	1.60 units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Visual Analogue Scale	67.47 units on a scale STANDARD_DEVIATION 18.01 • n=5 Participants	63.72 units on a scale STANDARD_DEVIATION 17.33 • n=7 Participants	65.6 units on a scale STANDARD_DEVIATION 17.74 • n=5 Participants
Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale EQ-5D Index	0.71 units on a scale STANDARD_DEVIATION 0.18 • n=5 Participants	0.69 units on a scale STANDARD_DEVIATION 0.16 • n=7 Participants	0.70 units on a scale STANDARD_DEVIATION 0.17 • n=5 Participants
Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 1	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 2	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 3	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 4	82 Participants n=5 Participants	77 Participants n=7 Participants	159 Participants n=5 Participants
Appearance Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale	17.1 units on a scale STANDARD_DEVIATION 9.53 • n=5 Participants	16.81 units on a scale STANDARD_DEVIATION 8.13 • n=7 Participants	16.96 units on a scale STANDARD_DEVIATION 8.85 • n=5 Participants
Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8	44.83 T-score STANDARD_DEVIATION 7.60 • n=5 Participants	44.71 T-score STANDARD_DEVIATION 6.77 • n=7 Participants	44.77 T-score STANDARD_DEVIATION 7.19 • n=5 Participants
Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 [	46.78 T-Score STANDARD_DEVIATION 9.29 • n=5 Participants	46.34 T-Score STANDARD_DEVIATION 8.75 • n=7 Participants	46.56 T-Score STANDARD_DEVIATION 9.01 • n=5 Participants
Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8	49.15 T-Score STANDARD_DEVIATION 9.06 • n=5 Participants	50.3 T-Score STANDARD_DEVIATION 8.29 • n=7 Participants	49.72 T-Score STANDARD_DEVIATION 8.69 • n=5 Participants
Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8	46.57 T Score STANDARD_DEVIATION 9.74 • n=5 Participants	46.66 T Score STANDARD_DEVIATION 8.96 • n=7 Participants	46.62 T Score STANDARD_DEVIATION 9.34 • n=5 Participants
Physical Function scale on the PROMIS® 29 Profile v 2.0 outcome measure	40.63 T Score STANDARD_DEVIATION 6.95 • n=5 Participants	40.17 T Score STANDARD_DEVIATION 6.15 • n=7 Participants	40.4 T Score STANDARD_DEVIATION 6.95 • n=5 Participants
Social Role scale on the PROMIS® 29 Profile v 2.0 outcome measure	43.74 T Score STANDARD_DEVIATION 8.63 • n=5 Participants	44.39 T Score STANDARD_DEVIATION 7.68 • n=7 Participants	44.06 T Score STANDARD_DEVIATION 8.17 • n=5 Participants
Anxiety scale on the PROMIS® 29 Profile v 2.0 outcome measure	53.85 T Score STANDARD_DEVIATION 9.72 • n=5 Participants	54.11 T Score STANDARD_DEVIATION 10.31 • n=7 Participants	53.98 T Score STANDARD_DEVIATION 10.0 • n=5 Participants
Depression scale on the PROMIS® 29 Profile v 2.0 outcome measure	51.04 T-Score STANDARD_DEVIATION 10.03 • n=5 Participants	51.59 T-Score STANDARD_DEVIATION 9.69 • n=7 Participants	51.31 T-Score STANDARD_DEVIATION 9.85 • n=5 Participants
Fatigue scale on the PROMIS® 29 Profile v 2.0 outcome measure	58.47 T-Score STANDARD_DEVIATION 10.52 • n=5 Participants	58.91 T-Score STANDARD_DEVIATION 10.31 • n=7 Participants	58.69 T-Score STANDARD_DEVIATION 10.40 • n=5 Participants
Pain Interference scale on the PROMIS® 29 Profile v 2.0 outcome measure	57.99 T-Score STANDARD_DEVIATION 9.37 • n=5 Participants	57.92 T-Score STANDARD_DEVIATION 9.22 • n=7 Participants	57.95 T-Score STANDARD_DEVIATION 9.28 • n=5 Participants
Visual Analogue Scale Pain Intensity scale on the PROMIS® 29 Profile v 2.0 outcome measure	4.08 T Score STANDARD_DEVIATION 2.21 • n=5 Participants	4.25 T Score STANDARD_DEVIATION 2.26 • n=7 Participants	4.16 T Score STANDARD_DEVIATION 2.24 • n=5 Participants
Sleep Disturbance scale on the PROMIS® 29 Profile v 2.0 outcome measure	55.22 T-score STANDARD_DEVIATION 6.96 • n=5 Participants	56.18 T-score STANDARD_DEVIATION 7.84 • n=7 Participants	55.7 T-score STANDARD_DEVIATION 7.41 • n=5 Participants
PHQ-8	8.61 units on a scale STANDARD_DEVIATION 5.39 • n=5 Participants	8.72 units on a scale STANDARD_DEVIATION 4.98 • n=7 Participants	8.67 units on a scale STANDARD_DEVIATION 5.18 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline compared with 16 weeks, 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 16 weeks	0.35 units on a scale Standard Deviation 6.12	0.94 units on a scale Standard Deviation 6.79
Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 6 months	0.50 units on a scale Standard Deviation 7.13	1.49 units on a scale Standard Deviation 6.67

SECONDARY outcome

Timeframe: Baseline compared with 16 weeks, 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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).

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale 16 weeks	0.002 units on a scale Standard Deviation 0.14	0.02 units on a scale Standard Deviation 0.14
Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale 6 months	0.002 units on a scale Standard Deviation 0.12	0.04 units on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline compared with 16 weeks, 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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".

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Confidence in Self Management on the Patient Activation Measure Scale 16 weeks	0.83 PAM level Standard Deviation 4.98	0.98 PAM level Standard Deviation 5.55
Change in Confidence in Self Management on the Patient Activation Measure Scale 6 months	0.90 PAM level Standard Deviation 5.22	1.70 PAM level Standard Deviation 4.50

SECONDARY outcome

Timeframe: Baseline compared with 16 weeks, 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale 16 weeks	0.82 units on a scale Standard Deviation 10.58	0.31 units on a scale Standard Deviation 9.56
Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale 6 months	0.18 units on a scale Standard Deviation 10.19	0.91 units on a scale Standard Deviation 9.88

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 16 weeks	0.17 units on a scale Standard Deviation 5.11	0.79 units on a scale Standard Deviation 4.52
Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 6 months	0.04 units on a scale Standard Deviation 4.56	0.48 units on a scale Standard Deviation 6.28

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 16 weeks	0.09 units on a scale Standard Deviation 6.28	0.73 units on a scale Standard Deviation 5.34
Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 6 months	0.71 units on a scale Standard Deviation 7.61	1.22 units on a scale Standard Deviation 7.66

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 16 weeks	0.54 units on a scale Standard Deviation 7.59	0.70 units on a scale Standard Deviation 6.29
Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 6 months	0.89 units on a scale Standard Deviation 8.31	0.49 units on a scale Standard Deviation 8.50

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 16 weeks	0.43 units on a scale Standard Deviation 6.94	0.99 units on a scale Standard Deviation 7.42
Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 6 months	0.40 units on a scale Standard Deviation 8.12	1.47 units on a scale Standard Deviation 7.95

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	0.05 units on a scale Standard Deviation 5.71	0.75 units on a scale Standard Deviation 4.83
Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	0.09 units on a scale Standard Deviation 4.93	1.08 units on a scale Standard Deviation 5.84

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	2.05 units on a scale Standard Deviation 17.19	2.24 units on a scale Standard Deviation 15.58
Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	1.19 units on a scale Standard Deviation 17.15	1.65 units on a scale Standard Deviation 15.29

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	0.16 units on a scale Standard Deviation 6.93	0.86 units on a scale Standard Deviation 7.64
Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	0.40 units on a scale Standard Deviation 8.55	-1.14 units on a scale Standard Deviation 8.35

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	0.08 units on a scale Standard Deviation 6.40	0.13 units on a scale Standard Deviation 6.76
Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	0.61 units on a scale Standard Deviation 7.75	-1.23 units on a scale Standard Deviation 7.95

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	0.005 units on a scale Standard Deviation 6.90	0.20 units on a scale Standard Deviation 7.19
Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	0.78 units on a scale Standard Deviation 6.90	-1.36 units on a scale Standard Deviation 8.36

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	-0.65 units on a scale Standard Deviation 6.96	-0.80 units on a scale Standard Deviation 6.95
Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	-0.58 units on a scale Standard Deviation 7.29	-1.03 units on a scale Standard Deviation 8.84

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	0.02 units on a scale Standard Deviation 1.91	-0.09 units on a scale Standard Deviation 2.32
Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	0.11 units on a scale Standard Deviation 1.78	0.19 units on a scale Standard Deviation 1.78

SECONDARY outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 16 weeks	-2.95 units on a scale Standard Deviation 6.22	-3.40 units on a scale Standard Deviation 6.62
Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure 6 months	-1.30 units on a scale Standard Deviation 6.74	-1.92 units on a scale Standard Deviation 6.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline compared to 16 weeks and 6 months

Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.

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.

Outcome measures

Measure	Internet-based Self-management Program n=123 Participants 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	Education Book Group n=124 Participants 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
Change in PHQ-8 16 weeks	-1.19 units on a scale Standard Deviation 5.02	-1.27 units on a scale Standard Deviation 4.99
Change in PHQ-8 6 months	-1.79 units on a scale Standard Deviation 5.06	1.63 units on a scale Standard Deviation 5.12

Adverse Events

Internet-based Self-management Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Education Book Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janet Poole

University of New Mexico

Phone: (505) 272-1753

Email: JPoole@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place