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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2980 | Placebo oral capsule; From August 2020 'no additional treatment' Wiki | 0.71 |
| drug3068 | Prednisolone 5 mg Wiki | 0.71 |
| drug3493 | SPIN-CHAT Program Wiki | 0.71 |
Navigate: Correlations HPO
There are 2 clinical trials
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.
Description: The mean difference in HAQ-DI at 3 months
Measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Time: Baseline to 3 monthsDescription: The difference in mRSS at 3 months
Measure: modified Rodnan Skin Score (mRSS) Time: Baseline to 3 monthsDescription: HAQ-DI
Measure: Quality of life and functional ability - Assessed by Questionnaire Time: Baseline to 6 weeks and 6 monthsDescription: Skin involvement as measured by the mRSS
Measure: Pain and disability Time: Baseline to 6 weeks and 6 monthsDescription: 11-point Scleroderma Functional Index
Measure: Functional ability - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Assessment of Pruritus
Measure: Pain associated with itch - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Cochin Hand Function
Measure: Hand function - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Functional Assessment of Chronic Illness Therapy (FACIT)
Measure: Fatigue - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: 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 monthsDescription: Helplessness Questionnaire
Measure: Health related quality of life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Short Form (36) Health Survey
Measure: Health related quality of life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: EuroQol 5 Dimensions
Measure: Health related quality of Life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Patient Global Assessment
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Physician Global Assessment
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: Assessment of Arthritis Index
Measure: Pain and disability - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Assessment in percentage change of mRSS
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsContagious 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.
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-randomizationDescription: 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-randomizationDescription: 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-randomizationDescription: 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-randomizationDescription: 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-randomizationDescription: 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-randomizationDescription: 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-randomizationDescription: 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-randomizationAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
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.
Drug Reports MeSH Reports HPO Reports