Intervention for Young Adults With Multiple Sclerosis

NCT04431323 | Completed

• 1 other identifier: 2676CESC
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

quality of life; young adults; biopsychosocial intervention

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Health-related Quality of Life up to 1 week post-intervention

  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.

  T0: baseline, T1: up to 1 week post-intervention

• Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire

  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.

  T1: up to 1 week post-intervention

Secondary Outcomes (25)

• Change from Baseline Resilience Features up to 1 week post-intervention

  T0: baseline, T1: up to 1 week post-intervention

• Change from Baseline Well-being up to 1 week post-intervention

  T0: baseline, T1: up to 1 week post-intervention

• Change from Baseline Mindfulness Traits up to 1 week post-intervention

  T0: baseline, T1: up to 1 week post-intervention

• Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS)

  T0: baseline, T1: up to 1 week post-intervention

• Change from Baseline Perceived Social Support up to 1 week post-intervention

  T0: baseline, T1: up to 1 week post-intervention

Study Arms (1)

biopsychosocial intervention

EXPERIMENTAL

Young adults with MS will receive an intervention (group setting) composed of physical activities (duration: 10-12 weeks; either dancing or walking) and psychosocial interventions (6-8 encounters). \[The intervention will start as soon as 8-10 patients will have been enrolled. A waiting list will be then created and patients contacted when the subsequent group starts. This waiting list does not serve as control group. One or more groups, respectively for the psychological intervention and the physical activities, may start at the same time but on different days, considering also the results of the co-creation phase.\]

Behavioral: ESPRIMO

Interventions

ESPRIMO BEHAVIORAL

Participants will receive the intervention during Phase 2. The intervention is based on the cognitive behavioral, the third-wave (mindfulness and acceptance and commitment therapy), and the positive psychology approach. The frequency of the intervention and the specific content and aims of the psychological and physical intervention will be based on the results of the surveys and the focus group discussion (Pre-phase and Phase 1). In order to maximize the benefit of the integrated intervention, all the three components of the interventions (i.e., psychological, motor exercise and social components) will be administered in the same time period. A preliminary theoretical framework of the intervention will be created prior to the survey phase according to the literature in the field. Specific aspects of this preliminary framework will be discussed during the co-creation phase and adapted after the analysis of the qualitative results.

biopsychosocial intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Explorative pre-phase "Exploring the psychological impact of the COVID-19 emergency"
• age range: 18-45 years;
• MS Diagnosis;
• Italian speakers;
• electronic informed consent signed.
• N/A
• Co-creation phase - Survey with young adults with MS
• age range: 18-45 years;
• MS diagnosis;
• Italian speakers;
• electronic informed consent signed.
• N/A
• Co-creation phase - Survey with Healthcare Providers
• being a healthcare professional working with MS patients;
• Italian speakers;

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi

Verona, Veneto, 37134, Italy

Location

Related Publications (23)

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  BACKGROUND

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  PMID: 38596329 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michela Rimondini

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

• Alberto Gajofatto Study Principal Investigator

  Azienda Ospedaliera Universitaria Integrata Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ESPRIMO is a feasibility study using a participatory design. It is composed of a pre-phase and three main consequential phases: * Pre-phase: Exploring the psychological impact of COVID-19 on young adults with MS using a cross-sectional web-based survey for patients with MS; * Phase 1 (Co-creation of the intervention): initial co-creation phase aiming to develop a biopsychosocial intervention (the so-called ESPRIMO intervention) targeted at young adults with MS, using cross-sectional web-based surveys for young adults with MS and healthcare providers as well as focus groups with patients; * Phase 2 (intervention): aiming to test preliminary effect, feasibility, and acceptability of the ESPRIMO intervention in a sample of young patients with MS; Phase 3 (Fine tuning of the intervention): evaluation of the results by the ESPRIMO Board (composed of four young adults with MS and three healthcare professionals) and subsequent fine-tuning of the ESPRIMO intervention.

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: June 16, 2020
• Study Start: May 13, 2020
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data can be made available upon reasonable request when data are published (6 months after publication).
• Access Criteria: Requestors will be required to sign a Data Access Agreement.

Locations

IT (1)