PeNSAMI Phase 2: a multicenter Italian trial of home-based palliative care for people with severe multiple sclerosis and their carers

Phase 2

Completed

• Conditions: Multiple Sclerosis (MS); Nervous System Diseases; Multiple sclerosis

• Registration Number: ISRCTN73082124
• Lead Sponsor: Foundation IRCCS Neurological Institute 'Carlo Besta' (Italy)

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-19
• Study Completion: 2016-11-01
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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
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)

Exclusion Criteria

1. Hospitalized/institutionalized patients
2. Patients already receiving palliative care
3. Patient-carer dyads living out of the study area

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Patient-related outcomes:<br> 1. SEIQoL-DW - It was developed to assess quality of life from the individual's perspective (O'Boyle 1992). It is an interview-based instrument to assess the level of functioning in, and relative importance of, areas of life nominated by the respondent. The SEIQoL-DW index is obtained from the satisfaction and the weight of each elicited area, and can range from 0 (worst possible score) to 100 (best possible HRQoL score).<br><br> 2. POS-S-MS - It comprises 18 items plus two open questions, using a 0-4 scale (Sleeman 2012). The psychometric properties of Core-POS (see below) and POS-S-MS have been assessed in patients severely affected by MS confirming that both are acceptable, reliable, and valid in this population (Sleeman 2012). An Italian version of POS-S-MS was devised for this study by the PeNSAMI lead centre. The score is the sum of the scores from each of the first 17 items, and therefore can range from 0 to 68.<br>