Multiple Sclerosis Clinical Trial
Official title:
Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention
Verified date | January 2016 |
Source | Fondazione Don Carlo Gnocchi Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | December 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Francesco Pagnini | Milan | Mi |
Lead Sponsor | Collaborator |
---|---|
Fondazione Don Carlo Gnocchi Onlus | Catholic University of the Sacred Heart |
Italy,
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* Note: There are 33 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54) | All subjects will be assigned to psychometric assessment | 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 | |
Primary | Evidence of an improved quality of life in caregivers as measured by the Short-Form-36 (SF-36) | All subjects will be assigned to psychometric assessment | 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 | |
Primary | 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) | All subjects will be assigned to psychometric assessment | 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 | |
Secondary | Evidence of an attained mindfulness level in patients with multiple sclerosis and in caregivers as measured by the Langer Mindfulness Scale (LMS) | All subjects will be assigned to psychometric assessment | 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 | |
Secondary | 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) | All subjects will be assigned to psychometric assessment | 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 | |
Secondary | 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 | 40 subjects will receive an actigraphy, a non-invasive method of monitoring human rest/activity cycles, that can be worn to measure gross motor activity | 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 | |
Secondary | Evidence of a decrease in fatigue in patients with multiple sclerosis and in caregivers as measured by the Modified Fatigue Impact Scale (MFIS) | All subjects will be assigned to psychometric assessment | 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 | |
Secondary | Evidence of a decrease in caregiver burden as measured by the Zarit Burden Interview (ZBI) | All subjects will be assigned to psychometric assessment | 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 |
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