MedTrace Logo

Development and Evaluation of a New Palliative Care Service for People Severely Affected With Multiple Sclerosis (MS)

NCT00364936 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-06-11

No results posted yet for this study

Summary

The primary purpose of this study is to develop, implement and conduct a preliminary evaluation of a new service for people who are severely affected by multiple sclerosis. The investigators conducted open interviews with patients, families and staff, plus a literature review to model and pilot this new service. Then the investigators developed, tested and ran the service and will evaluate it using a randomised controlled trial, where people affected by MS are randomised to either receive the service immediately (fast track group) or after a three month wait (standard best practice). This methodology follows that of the Medical Research Council (MRC) framework for the development and evaluation of complex services and treatments. The investigators interview people and their carers in the fast track and standard practice groups, and followed them over time. This phase of trial enables us to calculate sample size and test proof of concept for a full randomised trial. However, our working hypothesis was that there would be no difference between those people who received the fast track service or the standard best practice in terms of symptom controlled, and carer needs.

Conditions

Interventions

PROCEDURE

Palliative care service

Sponsors & Collaborators

Principal Investigators

  • Polly Edmonds, FRCP · King's College Hospital / King's College London

  • Irene J Higginson, BMBS FRCP FFPHM PhD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2006-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00364936 on ClinicalTrials.gov