ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change from Baseline Health-related Quality of Life up to 1 week post-intervention
研究概览
简要总结
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.
详细描述
Being the most common neurological disease causing disability in young adults, multiple sclerosis (MS) does not only impair physical functions but is also often associated with fatigue, symptoms of depression and anxiety as well as reduced health related quality of life (HRQoL). Especially the first years after the diagnosis can be emotionally challenging and psychological adjustment problematic. Since MS is generally detected between the ages of 20 and 40, a period of great significance for professional and personal development, the adaptation to this chronic disease may become even more challenging.
It is now well established that psychological interventions aiming to support people with MS (e.g., Cognitive Behavioural Therapy, mindfulness-based interventions) do not only have a positive effect on psychological aspects, such as resilience, but also on physiological outcomes (e.g., fatigue, physical vitality) and on the perception of general health.
According to the literature, psychological well-being and HRQoL can be also promoted by regular physical activity and exercise (e.g., walking, ballroom dancing), which present the additional advantage of reducing some physical symptoms of MS. Practicing physical activity in groups enables participants also to socialize and create interpersonal relationships, which in turn may significantly affect patients' psychological well-being and illness perception.
Despite the positive impact of interventions focusing on either physical, psychological or social/interpersonal dimensions, there has been little discussion about the development of comprehensive interventions based on the bio-psycho-social model of disease. Even less attention has been paid to the development of early interventions tailored to young adults' needs and to the engagement of patients in the creation of such programs despite the fact that patient engagement has become a central priority for researchers and policy makers in medicine.
Therefore, the investigators aim to develop - in collaboration with patients with MS - a psychosocial and motor intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age range: 18-45 years;
- •MS Diagnosis;
- •Italian speakers;
- •electronic informed consent signed.
排除标准
- •Co-creation phase - Survey with young adults with MS
- •Inclusion Criteria:
- •age range: 18-45 years;
- •MS diagnosis;
- •Italian speakers;
- •electronic informed consent signed.
- •Exclusion Criteria:
- •Co-creation phase - Survey with Healthcare Providers
- •Inclusion Criteria:
- •being a healthcare professional working with MS patients;
- •Italian speakers;
- •electronic informed consent signed.
- •Exclusion Criteria:
- •Co-creation phase - Focus groups
- •Inclusion Criteria:
- •age range: 18-45 years;
- •MS diagnosis;
- •Italian speakers;
- •signed informed consent.
- •Exclusion Criteria:
- •Intervention phase
- •Inclusion Criteria:
- •age range: 18-45 years;
- •Ms diagnosis according to the revised McDonald Criteria [Thompson et al., 2018];
- •Italian speakers;
- •Signed informed consent.
- •Exclusion Criteria:
- •clinically relevant cognitive deficits as evaluated by the treating neurologist which may represent obstacles in filling the questionnaires and participating in the intervention;
- •severe psychiatric disorders, such as psychosis, bipolar disorder, active substance abuse problems, dissociative disorders, or a current diagnosis of major depression as evaluated by the neurologist or the clinical psychologist;
- •clinically relevant physical impairments rendering impossible the physical activities included in the intervention, defined as an Expanded Disability Status Scale (EDSS) score higher than 3.5 [Bowen et al., 2001].
结局指标
主要结局
Change from Baseline Health-related Quality of Life up to 1 week post-intervention
时间窗: T0: baseline, T1: 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.
Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire
时间窗: T1: up to 1 week post-intervention
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.
次要结局
- Change from Baseline Resilience Features 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 Well-being up to 1 week post-intervention(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)
- Change from Baseline Committed Action up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Attitudes up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from baseline number of steps/day to 5 days post-intervention(T0: baseline, T1: 5 days 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 Levels of Anxiety and Depression up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Illness Representations up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Perceived Autonomy Support up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Subjective Norms up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from Baseline Perceived Behavioral Control up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from baseline km traveled/day to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Change from Baseline number of hours of sleep/day to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Change from baseline heart rate to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Change from Baseline Autonomous Motivation up to 1 week post-intervention(T0: baseline, T1: up to 1 week post-intervention)
- Change from baseline number of active hours/day to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Change from baseline number of inactive hours/day to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Change from baseline heart rate variability to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions(T1: up to 1 week post-intervention)
- Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention(T0: baseline, T1: 5 days post-intervention)
- Number of Drop Outs(T1: up to 1 week post-intervention)
- Exact Time of Dropping Out(T1: up to 1 week post-intervention)