Covid 19 Research using Clinical Trials (Home Page)
Report for D012598: Sclerosis NIH
(Synonyms: Scleros, Sclerosi, Sclerosis, Scoliosi)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug818 | ESPRIMO Wiki | 0.35 |
| drug42 | 40mg of MitoQ Wiki | 0.35 |
| drug23 | 20 mg MitoQ Wiki | 0.35 |
| drug1692 | Online support Group Wiki | 0.35 |
| drug2076 | Repository Corticotropin Injection Wiki | 0.35 |
| drug2169 | SPIN-CHAT Program Wiki | 0.35 |
| drug2093 | Rifampin Wiki | 0.25 |
| drug262 | Azithromycin Wiki | 0.06 |
| drug1822 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009103 | Multiple Sclerosis NIH | 0.82 |
| D005221 | Fatigue NIH | 0.41 |
| D012594 | Scleroderma, Localized NIH | 0.35 |
| D012595 | Scleroderma, Systemic NIH | 0.35 |
| D020529 | Multiple Sclerosis, Relapsing-Remitting NIH | 0.35 |
| D011014 | Pneumonia NIH | 0.02 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012378 | Fatigue HPO | 0.41 |
| HP:0012344 | Morphea HPO | 0.35 |
| HP:0002090 | Pneumonia HPO | 0.02 |
There are 8 clinical trials
Clinical Trials
1 Antibiotic Treatment Trial Directed Against Chlamydia Pneumonia in Multiple Sclerosis
Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.
NCT00043264 Multiple Sclerosis Drug: Rifampin Drug: Azithromycin MeSH:Pneumonia Multiple Sclerosis Sclerosis
HPO:Pneumonia
2 A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects With Relapsing-remitting Multiple Sclerosis
This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.
NCT03126760 Relapsing, Remitting Multiple Sclerosis Drug: Repository Corticotropin Injection Drug: Placebo MeSH:Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis
Primary Outcomes
Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.
Measure: Response rate on Expanded Disability Status Scale (EDSS) at Day 42 Time: Day 42Description: Data for AE and SAE will be presented.
Measure: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: Up to Day 42Description: Data will be summarized for each visit.
Measure: Change from Baseline in diastolic/systolic blood pressures Time: Baseline and Up to Day 42Measure: Change from Baseline in respiratory rate Time: Baseline and Up to Day 42
Measure: Change from Baseline in heart rate Time: Baseline and Up to Day 42
Measure: Change from Baseline in body temperature Time: Baseline and Up to Day 42
Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - Hematology Time: Baseline and Up to Day 42
Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities - blood chemistry Time: Baseline and Up to Day 42
Measure: Change from Baseline in Clinically Significant Laboratory Test Abnormalities -urinalysis Time: Baseline and Up to Day 42
Secondary Outcomes
Description: The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.
Measure: The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs) Time: Days 7, 14, 21 and 42Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.
Measure: The response rates on EDSS and 90% CIs on Day 7 and Day 21 Time: Days 7 and 21Description: The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).
Measure: Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs Time: Days 7, 21 and 423 MitoQ for Fatigue in Multiple Sclerosis: A Placebo Controlled Trial
The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.
NCT04267926 Multiple Sclerosis Fatigue Drug: 20 mg MitoQ Drug: Placebo Drug: 40mg of MitoQ MeSH:Multiple Sclerosis Sclerosis Fatigue
HPO:Fatigue
Primary Outcomes
Description: MFIS is a self -reported fatigue survey. Scale 0 - 84
Measure: Modified Fatigue Inventory Scale (MFIS) Time: 12 weeks
Secondary Outcomes
Description: SDMT measures cognitive function. Scale 0-110
Measure: Symbol Digit Modalities Test (SDMT) Time: 12 weeks
Description: EDSS measures neurological function. Scale 0-10
Measure: Expanded Disability Status Scale (EDSS) Time: 12 weeks
Description: BDI is a self-reported questionnaire measuring depression. Scale 0-21
Measure: Beck's Depression Inventory (BDI) Time: 12 weeks
4 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
Primary Outcomes
Description: MFIS is a self -reported fatigue survey. Scale 0 - 84
Measure: Modified Fatigue Inventory Scale (MFIS) Time: 12 weeksSecondary Outcomes
Description: SDMT measures cognitive function. Scale 0-110
Measure: Symbol Digit Modalities Test (SDMT) Time: 12 weeksDescription: EDSS measures neurological function. Scale 0-10
Measure: Expanded Disability Status Scale (EDSS) Time: 12 weeksDescription: BDI is a self-reported questionnaire measuring depression. Scale 0-21
Measure: Beck's Depression Inventory (BDI) Time: 12 weeksContagious 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 Scleroderma Scleroderma, Systemic Systemic Sclerosis 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
5 The UK MS Regsiter COVID-19 Substudy
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-randomizationSecondary 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-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-randomizationThe aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.
NCT04354519 Multiple Sclerosis COVID-19 MeSH:Multiple Sclerosis Sclerosis
Primary Outcomes
Description: Targeted questionnaire dependent on COVID Status
Measure: Incidence of COVID-19 Infections within an MS Cohort in the UK Time: Through study completion, an average of 1 yearDescription: Monitor admission rates in linked population
Measure: Hospitalisations in MS Patients with COVID-19 Time: 1 Year (regular outputs)Description: Death data from routinely reported government level data (HES/PEDW)
Measure: Mortality Time: 1 Year from study commencementSecondary Outcomes
Description: Patient Reported Outcome for MS disability
Measure: Patient Reported Expanded Disability Status Score Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for anxiety and depression
Measure: Hospital Anxiety and Depression Scale Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status
Measure: Multiple Sclerosis Impact Scale 29 V2 Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for walking status
Measure: Multiple Sclerosis Walking Scale 12 V2 Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for impact of fatigue
Measure: Fatigue Severity Scale Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for general quality of life
Measure: EuroQol 5D (3l) Time: 1 year (at least 6 monthly)6 SUNLIGHT Study: Online Support Groups for Multiple Sclerosis (MS) to Address COVID-19
Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.
NCT04379661 MS (Multiple Sclerosis) COVID-19 Support Groups Behavioral: Online support Group MeSH:Multiple Sclerosis Sclerosis
Primary Outcomes
Description: Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Measure: Rate of completion Time: Up to 12 weeksDescription: Acceptable rate is defined as at least 66% of sessions being attended.
Measure: Rate of adherence Time: Up to 12 weeksSecondary Outcomes
Description: The STAI is a commonly used measure of trait and state anxiety that is scored from 20 (minimum score) to 80 (maximum score), with a higher scores indicating higher anxiety (worse outcome).
Measure: Score on the State Trait Anxiety Inventory (STAI) Time: Up to 12 weeksDescription: Mood as measured by change in depression or depressive symptoms will be measured with the 8-item PHQ-8 which is scored from 0 (minimum score) to 24 (maximum score), in which higher scores indicate higher depression or depressive symptoms (worse outcome).
Measure: Score on the Personal Health Questionnaire Depression Scale (PHQ-8) Time: Up to 12 weeks7 ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
This study aims to develop - in collaboration with patients with multiple sclerosis (MS)- a psychosocial and physical activity intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' health-related quality of life (HRQoL). Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS. Given that the ESPRIMO study will be conducted immediately after the COVID-19 emergency, it does not seem reasonable to start the co-creation of the intervention without taking into account the potential impact of this pandemic on the quality of life and well-being of patients with MS and on their management of care. Thus, the investigators seek to better understand the needs of the target population under these particular circumstances.
NCT04431323 Multiple Sclerosis Behavioral: ESPRIMO MeSH:Multiple Sclerosis Sclerosis
Primary Outcomes
Description: Health-related Quality of Life at 1 day post-intervention will be Health-related quality of life will be measured by the Italian version of the "Coop/Wonca charts" [van Weel et al., 1993] at baseline and 1 day post-intervention assessing the changes between the two time points. The Coop/Wonca questionnaire is a self-reported single-item scale to explore HRQoL, including physical (fitness and daily activities), mental (emotions), social domains (social contacts) and above that general health and change in health status [Weel et al., 1995]. Each chart consists of a single question referring to the preceding two weeks and are scored on a 5-level ordinal scale ranging from 1 (no impact) to 5 (high impact), illustrated by a simple picture.
Measure: Change from Baseline Health-related Quality of Life up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: An ad hoc questionnaire (one of the two specific outcome measures evaluating the feasibility of the intervention) using closed (rated by Likert scales ranging from 1 (not at all) to 10 (very much, with higher scores reflecting higher levels of acceptance and satisfaction) and open questions will be administered to evaluate the acceptance and satisfaction of participants. Information on participants' experience will inform the intervention and its administration and will reduce barriers to participation for future patients.
Measure: Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire Time: T1: up to 1 week post-interventionSecondary Outcomes
Description: Resilience will be measured using the Italian version of the "Connor-Davidson Resilience Scale" [CD-RISC; Connor & Davidson, 2003] at baseline and 1 day post-intervention assessing the changes between the two time points. The CD-RISC is designed to assess resilience features in adolescents and adults and composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 "not true at all" to 4 "true nearly all of the time"), with higher scores reflecting higher levels of resilience.
Measure: Change from Baseline Resilience Features up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Well-being will be measured using the Italian version of the "Short Form 12 general health questionnaire" [SF12, Apolone et al., 2001] at baseline and 1 day post-intervention assessing the changes between the two time points. The SF12 is a validated 12-item questionnaire with Physical and Mental Component Summary (PCS and MCS, respectively) scores. The SF12 uses different types of scales (e.g., Yes/No questions, scales ranging from 1(always) to 6 (never)).
Measure: Change from Baseline Well-being up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Mindfulness traits will be assessed using the Italian version of the "Five Facet Mindfulness Questionnaire" [FFMQ; Baer et al., 2006; Giovannini et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points. The FFMQ-SF is a 24-item self-report questionnaire measuring one general mindfulness factor and five secondary facets (i.e., Observe, Describe, Act with Awareness, Nonjudge, and Nonreact) on a 5-point Likert scale, ranging from 1 ("never or very rarely true") to 5 ("very often or always true"), with higher total scores reflecting a greater degree of mindfulness.
Measure: Change from Baseline Mindfulness Traits up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Self-efficacy will be measured using the "Self-Efficacy in Multiple Sclerosis Scale" [SEMS; Bonino et al., 2016] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 15-item self-completion instrument using a 5-point Likert scale (from 0 = not at all confident to 4 = very confident). Items are conceptually allocated to two areas: "Goal setting" (9 items) and "Symptom management" (6 items).
Measure: Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS) Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived social support will be measured using the "Multidimensional Scale of Perceived Social Support" [MSPSS; Prezza & Principato, 2002; Zimet et al., 1988] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 12-item self-report measure, assessing on a 7-point Likert scale (from 1 "strongly disagree" to 7 "strongly agree") the level of perceived social support of various sources: family, friends, and significant others.
Measure: Change from Baseline Perceived Social Support up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Levels of anxiety and depression will be measured using the "Hospital Anxiety and Depression Scale" [HADS; Zigmond & Snaith, 1983; Costantini et al., 1999] at baseline and 1 day post-intervention assessing the changes between the two time points. The HADS is a brief self-report questionnaire composed of 14 items describing on a 4-point scale from 0 to 3 the levels of anxiety a person is experiencing. HADS anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms). A HADS-A and HADS-D score of ≥8 indicates a high risk of anxiety and depressive disorder.
Measure: Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Illness perception will be measured using the "Brief Illness Perception Questionnaire" [Brief IPQ-R; Broadbent et al., 2006; Pain et al., 2006] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 9-item self-completion instrument using a 5-point Likert scale (from "strongly disagree" to "strongly agree") providing a quantitative measurement of the components of illness representations [Leventhal et al., 1984; Leventhal et al., 1997].
Measure: Change from Baseline Illness Representations up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: The construct of committed action is measured applying the Italian version of the "The Committed Action Questionnaire-8" (CAQ-8) [McCracken et al., 2015] at baseline and 1 day post-intervention assessing the changes between the two time points. The CAQ-8, a short version of The Committed Action Questionnaire [McCracken, 2013], is an 8-item questionnaire using a 7-point Likert scale (from 0 = never true to 6 = always true).
Measure: Change from Baseline Committed Action up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Fatigue will be measured applying the "Fatigue Scale for Motor and Cognitive Functions" [FSMC; Penner et al., 2009; Elbers et al., 2012] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a self-report fatigue questionnaires validated in patients with multiple sclerosis (MS) and useful to evaluate both motor and cognitive fatigue. It is composed by 20 items evaluated on a Likert scale, ranging from 1 (it never happens) to 5 (it always happens), with higher scores reflecting higher levels of motor and cognitive fatigue.
Measure: Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived autonomy support (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Perceived Autonomy Support Scale for Exercise Setting" (PASSES; Hagger et al., 2007) at baseline and 1 day post-intervention assessing the changes between the two time points. The 12 items are rated on a 7-point Likert scale ranging from 1(totally disagree) to 7 (totally agree), with higher scores reflecting greater perceptions of autonomy support.
Measure: Change from Baseline Perceived Autonomy Support up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Autonomous motivation (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Behavioral Regulation in Exercise Questionnaire" [BREQ-3; Markland et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points. The 24 items are rated on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree).
Measure: Change from Baseline Autonomous Motivation up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Attitudes (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The scale comprises 6 items with responses provided on seven-points scales (with contrasting adjectives (e.g.,"bad - good", "harmful-beneficial").
Measure: Change from Baseline Attitudes up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Subjective norms (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The 3 items of the scale are rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with a greater single score (aggregated item scores) indicating greater normative social pressure toward the behavior.
Measure: Change from Baseline Subjective Norms up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived Behavioral Control (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The 3 items of the scale are rated on a 7-point Likert scale, with a greater single score (aggregated item scores) indicating greater perceived confidence toward the behavior.
Measure: Change from Baseline Perceived Behavioral Control up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of steps/day.
Measure: Change from baseline number of steps/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of km traveled/day.
Measure: Change from baseline km traveled/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of active hours/day.
Measure: Change from baseline number of active hours/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of inactive hours/day.
Measure: Change from baseline number of inactive hours/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of hours of sleep/day.
Measure: Change from Baseline number of hours of sleep/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate (HR).
Measure: Change from baseline heart rate to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate variability (HRV).
Measure: Change from baseline heart rate variability to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the estimated kilocalories consumed/day.
Measure: Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: The number of drop outs is the second specific outcome measure evaluating the feasibility of the intervention.
Measure: Number of Drop Outs Time: T1: up to 1 week post-interventionDescription: The exact time point of dropping out will also be assessed.
Measure: Exact Time of Dropping Out Time: T1: up to 1 week post-interventionDescription: Patients who drop out during the interventions will be contacted to assess the underlying reasons using an ad hoc questionnaire with open questions.
Measure: Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions Time: T1: up to 1 week post-intervention8 Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels of Multiple Sclerosis Patients in the COVID-19 Pandemic
Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack. When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.
NCT04438954 Multiple Sclerosis Covid-19 MeSH:Multiple Sclerosis Sclerosis Fatigue
HPO:Fatigue
Primary Outcomes
Description: Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9‐item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue
Measure: Fatigue Time: 4 week
Description: Physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ): short form. The online self-reporting questionnaire consisted of questions investigating the respondents' PA practice in terms of frequencies and durations of sitting, walking, moderate-intensity physical activities and vigorous-intensity physical activities. The MET-minutes per week (MET-min/week) were calculated using the following formula: intensity (MET) x duration x frequency. Physical activity levels were classified as physically inactive (<600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (> 3000 MET-min/week)
Measure: Physical activity Time: 4 week
Description: The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality.
Measure: Sleep quality Time: 4 week
Description: The Hospital Anxiety and Depression Scale (HADS) was composed by two subscales (i.e., anxiety and depression), with 7-items each. The anxiety part of HADS was used to evaluate the anxiety levels of the patients. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating higher anxiety level.
Measure: Anxiety Time: 4 week
HPO Nodes
Primary Outcomes
Description: Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9‐item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue
Measure: Fatigue Time: 4 weekDescription: Physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ): short form. The online self-reporting questionnaire consisted of questions investigating the respondents' PA practice in terms of frequencies and durations of sitting, walking, moderate-intensity physical activities and vigorous-intensity physical activities. The MET-minutes per week (MET-min/week) were calculated using the following formula: intensity (MET) x duration x frequency. Physical activity levels were classified as physically inactive (<600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (> 3000 MET-min/week)
Measure: Physical activity Time: 4 weekDescription: The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality.
Measure: Sleep quality Time: 4 weekDescription: The Hospital Anxiety and Depression Scale (HADS) was composed by two subscales (i.e., anxiety and depression), with 7-items each. The anxiety part of HADS was used to evaluate the anxiety levels of the patients. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating higher anxiety level.
Measure: Anxiety Time: 4 week