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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation

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Name (Synonyms) Correlation
D012598 Scoliosi NIH 0.35
D009103 Multiple Sclerosis NIH 0.33

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Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 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-intervention

Description: 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-intervention

Secondary 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: 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-intervention

Description: The exact time point of dropping out will also be assessed.

Measure: Exact Time of Dropping Out

Time: T1: up to 1 week post-intervention

Description: 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-intervention


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