Scleroderma
Conditions
Keywords
systemic sclerosis, ssc
Brief summary
This Study is a collaborative project with partners (people with scleroderma and stakeholders) designed to refine an internet program for patients with scleroderma and to compare the internet program to an authoritative educational book (Taking Charge of Systemic Sclerosis \[TOSS\]). During a 16-week comparative effectiveness 16-week randomized controlled trial, the investigators will recruit up to 250 patients who will be randomized to either TOSS or authoritative book for patients, The Scleroderma Book: A Guide for Patients and Families.
Interventions
OTHERInternet-based self-management program
OTHERScleroderma book
Sponsors
University of New Mexico
Medical University of South Carolina
Patient-Centered Outcomes Research Institute
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All participants will be residents of the United States * Diagnosed with systemic scleroderma, * 18 years of age * Possess basic computer literacy and have access to a computer with Internet and email capabilities * Have the ability to communicate in English
Exclusion criteria
* No computer access * Inability to communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale | Baseline compared with 16 weeks, 6 months | EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health). |
| Change in Confidence in Self Management on the Patient Activation Measure Scale | Baseline compared with 16 weeks, 6 months | The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full activated. |
| Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | Baseline compared with 16 weeks, 6 months | The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction. |
| Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 | Baseline compared to 16 weeks and 6 months | Managing Daily Activities score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms. |
| Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 | Baseline compared to 16 weeks and 6 months | Managing Emotions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms. |
| Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 | Baseline compared to 16 weeks and 6 months | Managing Medication and Treatment score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms. |
| Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 | Baseline compared to 16 weeks and 6 months | Managing Social Interactions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms. |
| Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better social role functioning and a lower score represents poorer social role functioning. |
| Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology. |
| Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology. |
| Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology. |
| Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology. |
| Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain. |
| Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | 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. |
| Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | Baseline compared to 16 weeks and 6 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in PHQ-8 | Baseline compared to 16 weeks and 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 134 |
| 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 | 133 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 22 | 25 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Internet-based Self-management Program | Education Book Group |
|---|---|---|---|
| Age, Continuous | 53.7 years STANDARD_DEVIATION 11.7 | 54.3 years STANDARD_DEVIATION 10.1 | 52.9 years STANDARD_DEVIATION 13.1 |
| Anxiety scale on the PROMIS® 29 Profile v 2.0 outcome measure | 53.98 T Score STANDARD_DEVIATION 10 | 53.85 T Score STANDARD_DEVIATION 9.72 | 54.11 T Score STANDARD_DEVIATION 10.31 |
| Appearance Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | 16.96 units on a scale STANDARD_DEVIATION 8.85 | 17.1 units on a scale STANDARD_DEVIATION 9.53 | 16.81 units on a scale STANDARD_DEVIATION 8.13 |
| Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 1 | 28 Participants | 14 Participants | 14 Participants |
| Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 2 | 30 Participants | 15 Participants | 15 Participants |
| Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 3 | 50 Participants | 23 Participants | 27 Participants |
| Confidence in Self Management on the Patient Activation Measure Scale Patient Activation Level 4 | 159 Participants | 82 Participants | 77 Participants |
| Depression scale on the PROMIS® 29 Profile v 2.0 outcome measure | 51.31 T-Score STANDARD_DEVIATION 9.85 | 51.04 T-Score STANDARD_DEVIATION 10.03 | 51.59 T-Score STANDARD_DEVIATION 9.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants | 105 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 49 Participants | 22 Participants | 27 Participants |
| Fatigue scale on the PROMIS® 29 Profile v 2.0 outcome measure | 58.69 T-Score STANDARD_DEVIATION 10.4 | 58.47 T-Score STANDARD_DEVIATION 10.52 | 58.91 T-Score STANDARD_DEVIATION 10.31 |
| Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 | 44.77 T-score STANDARD_DEVIATION 7.19 | 44.83 T-score STANDARD_DEVIATION 7.6 | 44.71 T-score STANDARD_DEVIATION 6.77 |
| Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 [ | 46.56 T-Score STANDARD_DEVIATION 9.01 | 46.78 T-Score STANDARD_DEVIATION 9.29 | 46.34 T-Score STANDARD_DEVIATION 8.75 |
| Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 | 49.72 T-Score STANDARD_DEVIATION 8.69 | 49.15 T-Score STANDARD_DEVIATION 9.06 | 50.3 T-Score STANDARD_DEVIATION 8.29 |
| Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 | 46.62 T Score STANDARD_DEVIATION 9.34 | 46.57 T Score STANDARD_DEVIATION 9.74 | 46.66 T Score STANDARD_DEVIATION 8.96 |
| Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 | 47.50 T-Score STANDARD_DEVIATION 8.49 | 47.41 T-Score STANDARD_DEVIATION 9.15 | 47.58 T-Score STANDARD_DEVIATION 7.81 |
| Pain Interference scale on the PROMIS® 29 Profile v 2.0 outcome measure | 57.95 T-Score STANDARD_DEVIATION 9.28 | 57.99 T-Score STANDARD_DEVIATION 9.37 | 57.92 T-Score STANDARD_DEVIATION 9.22 |
| PHQ-8 | 8.67 units on a scale STANDARD_DEVIATION 5.18 | 8.61 units on a scale STANDARD_DEVIATION 5.39 | 8.72 units on a scale STANDARD_DEVIATION 4.98 |
| Physical Function scale on the PROMIS® 29 Profile v 2.0 outcome measure | 40.4 T Score STANDARD_DEVIATION 6.95 | 40.63 T Score STANDARD_DEVIATION 6.95 | 40.17 T Score STANDARD_DEVIATION 6.15 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Anxiety | 1.60 units on a scale STANDARD_DEVIATION 0.61 | 1.56 units on a scale STANDARD_DEVIATION 0.61 | 1.63 units on a scale STANDARD_DEVIATION 0.62 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale EQ-5D Index | 0.70 units on a scale STANDARD_DEVIATION 0.17 | 0.71 units on a scale STANDARD_DEVIATION 0.18 | 0.69 units on a scale STANDARD_DEVIATION 0.16 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Mobility | 1.57 units on a scale STANDARD_DEVIATION 0.5 | 1.53 units on a scale STANDARD_DEVIATION 0.52 | 1.61 units on a scale STANDARD_DEVIATION 0.49 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Pain Discomfort | 1.98 units on a scale STANDARD_DEVIATION 0.46 | 1.93 units on a scale STANDARD_DEVIATION 0.48 | 2.02 units on a scale STANDARD_DEVIATION 0.43 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Self-Care | 1.31 units on a scale STANDARD_DEVIATION 0.49 | 1.28 units on a scale STANDARD_DEVIATION 0.48 | 1.79 units on a scale STANDARD_DEVIATION 0.49 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Usual Activities | 1.79 units on a scale STANDARD_DEVIATION 0.46 | 1.78 units on a scale STANDARD_DEVIATION 0.5 | 1.79 units on a scale STANDARD_DEVIATION 0.43 |
| Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Scale Visual Analogue Scale | 65.6 units on a scale STANDARD_DEVIATION 17.74 | 67.47 units on a scale STANDARD_DEVIATION 18.01 | 63.72 units on a scale STANDARD_DEVIATION 17.33 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 7 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 221 Participants | 112 Participants | 109 Participants |
| Region of Enrollment United States | 267 Participants | 134 Participants | 133 Participants |
| Sex: Female, Male Female | 243 Participants | 123 Participants | 120 Participants |
| Sex: Female, Male Male | 24 Participants | 11 Participants | 13 Participants |
| Sleep Disturbance scale on the PROMIS® 29 Profile v 2.0 outcome measure | 55.7 T-score STANDARD_DEVIATION 7.41 | 55.22 T-score STANDARD_DEVIATION 6.96 | 56.18 T-score STANDARD_DEVIATION 7.84 |
| Social Role scale on the PROMIS® 29 Profile v 2.0 outcome measure | 44.06 T Score STANDARD_DEVIATION 8.17 | 43.74 T Score STANDARD_DEVIATION 8.63 | 44.39 T Score STANDARD_DEVIATION 7.68 |
| Visual Analogue Scale Pain Intensity scale on the PROMIS® 29 Profile v 2.0 outcome measure | 4.16 T Score STANDARD_DEVIATION 2.24 | 4.08 T Score STANDARD_DEVIATION 2.21 | 4.25 T Score STANDARD_DEVIATION 2.26 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 134 | 0 / 133 |
| other Total, other adverse events | 0 / 134 | 0 / 133 |
| serious Total, serious adverse events | 0 / 134 | 0 / 133 |
Outcome results
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.
Time frame: Baseline compared with 16 weeks, 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 | 16 weeks | 0.94 units on a scale | Standard Deviation 6.79 |
| Education Book Group | Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8 | 6 months | 1.49 units on a scale | Standard Deviation 6.67 |
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.32Wilcoxon (Mann-Whitney)
p-value: 0.3Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -1.14 units on a scale | Standard Deviation 8.35 |
| Education Book Group | Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.86 units on a scale | Standard Deviation 7.64 |
p-value: 0.83Wilcoxon (Mann-Whitney)
p-value: 0.27Wilcoxon (Mann-Whitney)
p-value: 0.18Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared with 16 weeks, 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | 16 weeks | 0.82 units on a scale | Standard Deviation 10.58 |
| Internet-based Self-management Program | Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | 6 months | 0.18 units on a scale | Standard Deviation 10.19 |
| Education Book Group | Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | 16 weeks | 0.31 units on a scale | Standard Deviation 9.56 |
| Education Book Group | Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale | 6 months | 0.91 units on a scale | Standard Deviation 9.88 |
p-value: 0.96Wilcoxon (Mann-Whitney)
p-value: 0.69Wilcoxon (Mann-Whitney)
p-value: 0.6Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared with 16 weeks, 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | Change in Confidence in Self Management on the Patient Activation Measure Scale | 16 weeks | 0.83 PAM level | Standard Deviation 4.98 |
| Internet-based Self-management Program | Change in Confidence in Self Management on the Patient Activation Measure Scale | 6 months | 0.90 PAM level | Standard Deviation 5.22 |
| Education Book Group | Change in Confidence in Self Management on the Patient Activation Measure Scale | 16 weeks | 0.98 PAM level | Standard Deviation 5.55 |
| Education Book Group | Change in Confidence in Self Management on the Patient Activation Measure Scale | 6 months | 1.70 PAM level | Standard Deviation 4.5 |
p-value: 0.68Wilcoxon (Mann-Whitney)
p-value: 0.83Wilcoxon (Mann-Whitney)
p-value: 0.23Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.08 units on a scale | Standard Deviation 6.4 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.13 units on a scale | Standard Deviation 6.76 |
| Education Book Group | Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -1.23 units on a scale | Standard Deviation 7.95 |
p-value: 0.64Wilcoxon (Mann-Whitney)
p-value: 0.8Wilcoxon (Mann-Whitney)
p-value: 0.09Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.005 units on a scale | Standard Deviation 6.9 |
| Internet-based Self-management Program | Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | 0.78 units on a scale | Standard Deviation 6.9 |
| Education Book Group | Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.20 units on a scale | Standard Deviation 7.19 |
| Education Book Group | Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -1.36 units on a scale | Standard Deviation 8.36 |
p-value: 0.73Wilcoxon (Mann-Whitney)
p-value: 0.82Wilcoxon (Mann-Whitney)
p-value: 0.04Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 | 16 weeks | 0.79 units on a scale | Standard Deviation 4.52 |
| Education Book Group | Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8 | 6 months | 0.48 units on a scale | Standard Deviation 6.28 |
p-value: 0.89Wilcoxon (Mann-Whitney)
p-value: 0.32Wilcoxon (Mann-Whitney)
p-value: 0.56Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 | 16 weeks | 0.73 units on a scale | Standard Deviation 5.34 |
| Education Book Group | Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8 | 6 months | 1.22 units on a scale | Standard Deviation 7.66 |
p-value: 0.69Wilcoxon (Mann-Whitney)
p-value: 0.29Wilcoxon (Mann-Whitney)
p-value: 0.07Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 | 6 months | 0.49 units on a scale | Standard Deviation 8.5 |
| Education Book Group | Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8 | 16 weeks | 0.70 units on a scale | Standard Deviation 6.29 |
p-value: 0.28Wilcoxon (Mann-Whitney)
p-value: 0.16Wilcoxon (Mann-Whitney)
p-value: 0.23Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 | 16 weeks | 0.99 units on a scale | Standard Deviation 7.42 |
| Education Book Group | Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8 | 6 months | 1.47 units on a scale | Standard Deviation 7.95 |
p-value: 0.93Wilcoxon (Mann-Whitney)
p-value: 0.54Wilcoxon (Mann-Whitney)
p-value: 0.33Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.75 units on a scale | Standard Deviation 4.83 |
| Education Book Group | Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | 1.08 units on a scale | Standard Deviation 5.84 |
p-value: 0.59Wilcoxon (Mann-Whitney)
p-value: 0.25Wilcoxon (Mann-Whitney)
p-value: 0.12Wilcoxon (Mann-Whitney)
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).
Time frame: Baseline compared with 16 weeks, 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale | 16 weeks | 0.02 units on a scale | Standard Deviation 0.14 |
| Education Book Group | Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale | 6 months | 0.04 units on a scale | Standard Deviation 0.15 |
p-value: 0.08Wilcoxon (Mann-Whitney)
p-value: 0.05Wilcoxon (Mann-Whitney)
p-value: 0.008Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | -3.40 units on a scale | Standard Deviation 6.62 |
| Education Book Group | Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -1.92 units on a scale | Standard Deviation 6.65 |
p-value: 0.29Wilcoxon (Mann-Whitney)
p-value: 0.58Wilcoxon (Mann-Whitney)
p-value: 0.49Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 2.24 units on a scale | Standard Deviation 15.58 |
| Education Book Group | Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | 1.65 units on a scale | Standard Deviation 15.29 |
p-value: 0.51Wilcoxon (Mann-Whitney)
p-value: 0.93Wilcoxon (Mann-Whitney)
p-value: 0.84Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | 0.19 units on a scale | Standard Deviation 1.78 |
| Education Book Group | Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -0.09 units on a scale | Standard Deviation 2.32 |
p-value: 0.05Wilcoxon (Mann-Whitney)
p-value: 0.62Wilcoxon (Mann-Whitney)
p-value: 0.7Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | 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 |
| Internet-based Self-management Program | 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 |
| Education Book Group | Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 16 weeks | -0.80 units on a scale | Standard Deviation 6.95 |
| Education Book Group | Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure | 6 months | -1.03 units on a scale | Standard Deviation 8.84 |
p-value: 0.95Wilcoxon (Mann-Whitney)
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.63Wilcoxon (Mann-Whitney)
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.
Time frame: Baseline compared to 16 weeks and 6 months
Population: Population analyzed at 6 months differs due to drop outs shown in participant flow table.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internet-based Self-management Program | Change in PHQ-8 | 16 weeks | -1.19 units on a scale | Standard Deviation 5.02 |
| Internet-based Self-management Program | Change in PHQ-8 | 6 months | -1.79 units on a scale | Standard Deviation 5.06 |
| Education Book Group | Change in PHQ-8 | 16 weeks | -1.27 units on a scale | Standard Deviation 4.99 |
| Education Book Group | Change in PHQ-8 | 6 months | 1.63 units on a scale | Standard Deviation 5.12 |
p-value: 0.87Wilcoxon (Mann-Whitney)
p-value: 0.89Wilcoxon (Mann-Whitney)
p-value: 0.82Wilcoxon (Mann-Whitney)