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D012595: Scleroderma, Systemic

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

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Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug2556 Placebo oral capsule; From August 2020 'no additional treatment' Wiki 0.71
drug2979 SPIN-CHAT Program Wiki 0.71
drug2626 Prednisolone 5 mg Wiki 0.71

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D012594 Scleroderma, Localized NIH 0.71
D012598 Scoliosi NIH 0.50

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0012344 Morphea HPO 0.71

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Phase II Randomised Study of Oral Prednisolone in Early Diffuse Cutaneous Systemic Sclerosis (Initially Double-blind, Then Switched to Open-label Because of Covid-19)

This is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within 3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years. Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months. Please note: From August 2020, the trial was re-started following halt due to Covid-19 as open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at study exit.

NCT03708718
Conditions
  1. Systemic Sclerosis
Interventions
  1. Drug: Prednisolone 5 mg
  2. Drug: Placebo oral capsule; From August 2020 'no additional treatment'
MeSH:Scleroderma, Systemic Scleroderma, Diffuse Sclerosis

Primary Outcomes

Description: The mean difference in HAQ-DI at 3 months

Measure: Health Assessment Questionnaire Disability Index (HAQ-DI)

Time: Baseline to 3 months

Description: The difference in mRSS at 3 months

Measure: modified Rodnan Skin Score (mRSS)

Time: Baseline to 3 months

Secondary Outcomes

Description: HAQ-DI

Measure: Quality of life and functional ability - Assessed by Questionnaire

Time: Baseline to 6 weeks and 6 months

Description: Skin involvement as measured by the mRSS

Measure: Pain and disability

Time: Baseline to 6 weeks and 6 months

Description: 11-point Scleroderma Functional Index

Measure: Functional ability - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Assessment of Pruritus

Measure: Pain associated with itch - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Cochin Hand Function

Measure: Hand function - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Functional Assessment of Chronic Illness Therapy (FACIT)

Measure: Fatigue - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Hospital Anxiety and Depression Scale (HADS) . This questionnaire has 14 questions, each with 4 options designed to assess aspects of mental health

Measure: Anxiety and depression - Assessed by questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Helplessness Questionnaire

Measure: Health related quality of life - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Short Form (36) Health Survey

Measure: Health related quality of life - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: EuroQol 5 Dimensions

Measure: Health related quality of Life - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Patient Global Assessment

Measure: Pain and disability

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Physician Global Assessment

Measure: Pain and disability

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Digital Ulcer Count: The site and total number of ulcers on the hand are recorded by the patients clinician on a diagram of a hand

Measure: Assessment of pain - Clinician assessment

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Tender Friction Rubs - the total number of tendon friction rubs on 12 possible anatomical sites are recorded

Measure: Assessment of pain - Clinician assessment

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Joint Count: The number of tender or swollen joints are assessed from 14 anatomical sites (both left and right side) and recorded out of a total of 28 (14 sites, left and right side) tender joints and 28 swollen joints

Measure: Assessment of pain - Clinician assessment

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Assessment of Arthritis Index

Measure: Pain and disability - Assessed by Questionnaire

Time: Baseline to 6 weeks, 3 months and 6 months

Description: Assessment in percentage change of mRSS

Measure: Pain and disability

Time: Baseline to 6 weeks, 3 months and 6 months
2 A Partially Nested RCT to Evaluate the Effectiveness of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Program to Reduce Anxiety Among At-Risk Scleroderma Patients

Contagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.

NCT04335279
Conditions
  1. Scleroderma
  2. Scleroderma, Systemic
  3. Systemic Sclerosis
Interventions
  1. Other: SPIN-CHAT Program
MeSH:Scleroderma, Systemic Scleroderma, Diffuse Scleroderma, Localized Sclerosis
HPO:Morphea Scleroderma

Primary Outcomes

Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.

Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

Time: 4-weeks post-randomization

Secondary Outcomes

Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.

Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0

Time: 10-weeks post-randomization

Description: PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.

Measure: Depression symptoms: Patient Health Questionnaire (PHQ-8)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18.

Measure: Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.

Measure: Boredom: Multidimensional State Boredom Scale (MSBS-8)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults.

Measure: Physical activity: International Physical Activity Questionnaire - modified for the elderly (IPAQ-E)

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.

Measure: Adverse Effects

Time: 4-weeks post-randomization, 10-weeks post-randomization

Description: The COVID-19 Fears Questionnaire for Chronic Medical Conditions is a 10-item scale that ask participants to rate, on a typical day in the last week, how much they were afraid from "not at all" to "extremely" about aspects of COVID-19. Items are scored on a 5-point scale (range 1-5). Higher scores represent greater fear. The scale has been validated among people with scleroderma.

Measure: Fear: COVID-19 Fears Questionnaire for Chronic Medical Conditions

Time: 4-weeks post-randomization, 10-weeks post-randomization

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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