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Community Based Intervention for Severe CFS/ME

Feasibility Study for a Community Based Intervention for Individuals with Severe CFS/ME

Specialty
Neurological
Portfolio Eligibility
Automatically eligible
ISRCTN
EudraCT
MREC N° 13/SC/0046
UKCRN ID 14727
WHO ID
Research Summary
Chronic Fatigue Syndrome/ME is an illness characterised by debilitating pain and fatigue which is estimated to affect up to 250,000 people in the UK. The aetiology is unknown. At its most severe, CFS/ME can lead to individuals becoming housebound, wheelchair and bedbound, and dependent on carers for all activities of daily living. The illness can last for decades, leaving many severely affected individuals profoundly disabled and socially isolated. It is estimated that up to 25% of patients with CFS/ME are severely affected. Whilst significant progress has been made in researching and treating CFS/ME in mild to moderately affected individuals, housebound patients are generally too ill to travel to out-patient appointments for treatment or research. There are currently few in-patient beds in the UK for this patient group. In consequence, there is a serious gap both in research evidence and effective help for these individuals; as highlighted by successive national reports on CFS/ME. This feasibility study will pilot an innovative, multi-disciplinary approach which has been developed through 2 years of collaborative work in Dorset between specialist health professionals, patients with experience of recovery, researchers and patient support groups drawing on the concept of 'Modelling Success', taken from Neuro-Linguistic Programming (NLP). In this process, insights from individuals with experience of recovery have been combined with expertise from specialist health professionals to: • identify recovery skills. • develop innovative ways of communicating these skills with patients who may have cognitive difficulties making it difficult for them to read, use a computer or engage in conversation. This study will: • pilot a community based intervention for 20 individuals severely affected by CFS/ME in Dorset, Oxford and Hampshire. • evaluate this intervention following the MRC guidance on best practice for evaluating complex interventions.
Study Type Interventional
Design Type Not specified
Disease(s) Nervous system disorders
Phase Pilot/Feasibility
Current Status Open
Closure Date 12/1/2016
Global Sample Size 27
Global Recruitment to Date
  33%
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites No
Main Inclusion Criteria
1. Chronic Fatigue Syndrome/ME according to CDC 1994 diagnostic criteria.
2. Categorisation of illness severity as 'severe' or 'very severe' according to the Cox-Findley severity categories, using the screening tool designed by Cox 2012. Note – both categories are merged and defined as 'severe' by NICE 2007 Guideliness.
3. Able to comprehend English to a sufficient level to fully understand study information (e.g. Patient Information Sheet) in order to be able to give informed written consent.
4. Able to provide informed consent either through signing consent form, or for patients whose physical disability makes full signature difficult, by making written mark witnessed by independent witness.
Main Exclusion Criteria
1. Major psychiatric co-morbidity (note: CDC 1994 criteria require that major psychiatric co-morbidities are excluded before a diagnosis of CFS/ME is given. In this study, all patients applying for the study will be screened by a specialist CFS/ME physician prior to entry to study).
2. Other major known physical co-morbidities, including diagnoses of cancer, heart disease, autoimmune disorders, AIDS. As above, patients will be screened prior to entry to exclude co-morbidities.
Chief Investigator(s)
Dr Selwyn Richards
Further details, please contact
Ms Clare McDermott

Poole Hospital NHS Foundation Trust
Longfleet road

Tel: 079 419 63137
crm20@soton.ac.uk
Funder(s) NIHR - School for Primary Care Research
Sponsor(s) University of Southampton




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