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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial

Authors: Alessandra Solari, Andrea Giordano, Maria Grazia Grasso, Paolo Confalonieri, Francesco Patti, Alessandra Lugaresi, Lucia Palmisano, Roberta Amadeo, Giovanni Martino, Michela Ponzio, Giuseppe Casale, Claudia Borreani, Renzo Causarano, Simone Veronese, Paola Zaratin, Mario Alberto Battaglia, on behalf of the PeNSAMI project

Published in: Trials | Issue 1/2015

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Abstract

Background

Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers.

Methods/design

This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient’s caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary.
HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner’s visits and telephone interviews, but not the team visits.
Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths.
The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients’ caring physicians).

Discussion

The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention.

Trial registration

The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124) on 19 June 2014.
Appendix
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Metadata
Title
Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial
Authors
Alessandra Solari
Andrea Giordano
Maria Grazia Grasso
Paolo Confalonieri
Francesco Patti
Alessandra Lugaresi
Lucia Palmisano
Roberta Amadeo
Giovanni Martino
Michela Ponzio
Giuseppe Casale
Claudia Borreani
Renzo Causarano
Simone Veronese
Paola Zaratin
Mario Alberto Battaglia
on behalf of the PeNSAMI project
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0695-0

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