An interventional study of B-HIPE (Brief High Impact Preparatory Experience) in Multiple Sclerosis, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-05-11.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Not applicable, Interventional, and Treatment
Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.
The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A group of pwMS participate in a multidimensional integrate high-motivating rehabilitation program for the change of lifestyle and bad habits.
Behavioral: B-HIPE (Brief High Impact Preparatory Experience)
The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course). Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program.
FS-36 Health Related Quality of Life (HRQoL)
Questionnaire to Measure Health-Related Quality of Life
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
The Fatigue Severity Scale (FSS)
Questionnaire to Measure the fatigue
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Food frequency questionnaire (FFQ)
Questionnaire to evaluate usual frequency of foods and beverages
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
MSIS29- Multiple Sclerosis Impact Scale
A scale for the evaluation of the impact of MS on day-to-day life
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
MOS Sleep Scale (MOSS)
A scale for the evaluation of the quality and the quantity of sleep
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Restless Legs Scale (RLS)
A scale for the evaluation of the restless legs syndrome
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Six minute walking test (6MWT)
An exercise test used to assess aerobic capacity and endurance
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
Hospital Anxiety and Depression Scale (HADS)
A self-assessment scale for detecting states of depression and anxiety
Time frame: Change between the baseline - T0 (before the intervention) and 1 month after the end of the intervention (T1)
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus