ISRCTN73082124
Completed
Phase 2
The Palliative Network for Severely Affected Adults with Multiple Sclerosis in Italy (PeNSAMI) Phase 2: a multicentre, phase II/III, single-blind, randomized controlled trial of home-based palliative care vs standard care for people with severe multiple sclerosis and their carers, and nested qualitative study
Foundation IRCCS Neurological Institute 'Carlo Besta' (Italy)0 sites75 target enrollmentJune 19, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis (MS)
- Sponsor
- Foundation IRCCS Neurological Institute 'Carlo Besta' (Italy)
- Enrollment
- 75
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25899519 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28381133 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30001423 2021 cost-effectiveness results in https://pubmed.ncbi.nlm.nih.gov/33486403/ (added 25/01/2021)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible for recruitment if all of the following criteria are satisfied:
- •1\. Definite MS (Polman 2011\)
- •2\. Age \=18 years
- •3\. Primary or secondary progressive MS course
- •4\. EDSS \= 8\.0
- •5\. Two or more unmet care needs from those identified in PeNSAMI Phase 1 (see above), or patient choice for comfort care only
- •6\. One or more of the following patient clinical indicators (Thomas 2011\):
- •6\.1\. Significant complex symptoms and medical complications
- •6\.2\. Dysphagia and poor nutritional status
- •6\.3\. Communication difficulties
Exclusion Criteria
- •1\. Hospitalized/institutionalized patients
- •2\. Patients already receiving palliative care
- •3\. Patient\-carer dyads living out of the study area
Outcomes
Primary Outcomes
Not specified
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