Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54)
研究概览
简要总结
The aim of the project is to investigate the impact of a multiple sclerosis specific telemedicine mindfulness-based Intervention on the quality of life of people with multiple sclerosis and their caregivers.
详细描述
The mindfulness protocol will be modified according to multiple sclerosis clinical peculiarities and implemented with a multimedia web-based software.
The project will be divided in two parts. During the first phase of the project, a standard mindfulness-based stress reduction protocol will be modified according to clinical peculiarities and specific needs of people with multiple sclerosis. In the meanwhile, a multimedia software with these teaching will be developed, so that the training could be available online, from home. The protocol and the software will be tested for ergonomics in a pilot, qualitative, study.
In the second phase, a randomized clinical trial will be performed. One-hundred and twenty multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental or to the control group. Subjects in the experimental group will attend the telemedicine mindfulness intervention, while controls will join a psycho-educational telemedicine program. At baseline, post-treatment and at a 6-month follow-up, participants will be assessed for quality of life, anxiety, depression, quality of sleep and mindfulness level. A subgroup of subjects will be assessed with actigraphs, for an objective evaluation of their sleep and physical activity. Experimental subjects will be assessed for participation and engagement to the treatment. Data will be analyzed with a complex longitudinal design, considering both within and between groups comparisons.
The dissemination process will involve scientific publication on neurological and psychological journals, a book, scientific meeting presentations and communication to general media. If there will be a positive effect of the mindfulness software, it will be diffused to multiple sclerosis clinics and associations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis.
- •Ability to communicate and to understand tasks.
- •No change of disease-modifying treatment in the 3 months before the enrolment.
- •No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
- •Availability of a personal computer, smartphone or tablet (compatible with the software).
- •Provided informed consent for study participation.
排除标准
- •Being a person who lives with the multiple sclerosis patient and provides him/her with most care and assistance
- •Ability to communicate and to understand tasks
- •Availability of a personal computer, smartphone or tablet (compatible with the software).
- •Provided informed consent for study participation
研究组 & 干预措施
Telemedicine mindfulness intervention
Participants are assigned to a telemedicine mindfulness intervention group. The protocol lasts 8 weeks and it is composed by one online course session each week and home exercises. The course sessions, with a synchronous communication, will be conducted by a trainer, through teleconferences, that will explain how to practice the exercises to develop mindfulness attitude, following the mindfulness-based intervention-multiple sclerosis protocol. Subjects will be able to take part of these sessions everywhere, through a computer, tablet o mobile. During these sessions, individuals will interact with the trainer with teleconference or textual communications.
干预措施: Telemedicine mindfulness-based intervention (Behavioral)
Psycho-education control group
Psycho-education control group, provided with a telemedicine approach. Subject in this group will use a similar software than the experimental intervention, with identical time efforts required. Software contents will be psycho-educative.
干预措施: Psycho-education intervention (Behavioral)
结局指标
主要结局
Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54)
时间窗: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention
All subjects will be assigned to psychometric assessment
Evidence of an improved quality of life in caregivers as measured by the Short-Form-36 (SF-36)
时间窗: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention
All subjects will be assigned to psychometric assessment
Evidence of a decrease of anxiety and depression in patients with multiple sclerosis and in caregivers as measured by the Hospital Anxiety and Depression Scale (HADS)
时间窗: First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention
All subjects will be assigned to psychometric assessment
次要结局
- Evidence of an attained mindfulness level in patients with multiple sclerosis and in caregivers as measured by the Langer Mindfulness Scale (LMS)(first assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention)
- Evidence of a decrease of sleep disturbance and fatigue and a better quality of sleep in patients with multiple sclerosis as measured by actigraphy unit(First assessment includes the entires two weeks preceding the start of the intervention (baseline condition); second assessment includes the entire two weeks after the end of the intervention)
- Evidence of a decrease of sleep disturbance and better quality of sleep in patients with multiple sclerosis and in caregivers as measured by the Medical Outcomes Study Sleep Measure (MOSssm)(First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention)
- Evidence of a decrease in caregiver burden as measured by the Zarit Burden Interview (ZBI)(First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention)
- Evidence of a decrease in fatigue in patients with multiple sclerosis and in caregivers as measured by the Modified Fatigue Impact Scale (MFIS)(First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention)