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 个研究点目标入组 75 人开始时间: 2014年6月19日最近更新: 2021年2月8日

适应症

试验速览

•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
•6.4. Cognitive impairment, notably the onset of dementia
•7. Presence of a carer (family member, relative, or friend, who is next of kin or is the key decision maker as designated by the [cognitively competent] patient and with whom the patient shares his/her life)
•8. Signed informed consent (of both patient and carer)

发起方

Foundation IRCCS Neurological Institute 'Carlo Besta' (Italy)