Randomised controlled trial of nurse led self-help treatment for primary care patients with chronic fatigue syndrome

Lead Research Organisation: University of Manchester
Department Name: Medical and Human Sciences

Abstract

Patients with Chronic Fatigue Syndrome (CFS, also known as ME) experience severe, disabling fatigue, together with other symptoms including muscle pain and memory and concentration problems. A recent report commissioned by the DH emphasised the cost of CFS/ME both to patients and to society. The government therefore called for more research into the condition and its treatment.

Cognitive behaviour therapy has been shown to be an effective treatment for CFS/ME, but is costly and not widely available. However, we recently developed a briefer treatment which improved both fatigue and functioning in hospital out-patients. The treatment springs from our understanding that in CFS the body becomes dysregulated and ceases to function properly. We firstly give patients (verbally and in booklet form) an understandable and reassuring explanation of their symptoms. We then prescribe a programme of gradually increasing activity, supported with advice on regaining healthy sleep patterns, and dealing with stress and anxiety.

Our trial will test whether general nurses can be taught to provide this treatment to patients seen normally seen by GPs. We want to see whether the treatment is more effective than simply being in contact with a supportive therapist, and more cost-effective than the treatment which patients usually receive from GPs. If so, we anticipate that our treatment could be adopted at primary care level, that it will improve the health and life-quality of CFS/ME patients, and bring important economic benefits.

Technical Summary

Objectives:
1.To assess clinical- and cost-effectiveness of a brief self-help treatment (pragmatic rehabilitation) delivered at home by nurses to patients with chronic fatigue syndrome recruited from primary care. 2. To elucidate mechanisms of action of pragmatic rehabilitation, and barriers to its implementation

Methods
Setting: GP practices across the North West, via Primary Care Organisations.
Subjects: Patients aged over 16 who fulfil the CDC criteria for chronic fatigue syndrome.
Design: Single-blind pragmatic randomised controlled trial of a brief self-help treatment (pragmatic rehabilitation), delivered by specially trained nurses in the patients? home, and compared with both supportive listening (to control for therapist contact time) and treatment as usual by the primary care team. The pragmatic rehabilitation arm involves a detailed physiological explanation of symptom patterns followed by a treatment programme focussing on graded exercise, sleep and relaxation. The supportive listening arm will provide emotional support and validation for the patient through the development of a collaborative relationship in which the patient is held in unconditional positive regard. In addition, three phases of qualitative interviews will be carried out with sub-samples of patients and GPs to determine the mechanisms of action of the intervention and to identify barriers to its implementation.
Outcome measures: Primary: subjective physical functioning via SF-36; cost-effectiveness via EuroQol. Secondary: scores on Fatigue, Hospital Anxiety and Depression, and Sleep Scales; timed step-test for exercise tolerance and cardiovascular fitness. Economic evaluation based on resource-use data.
Follow-up: 6 and 12 months after completion of treatment.

Application/exploitation of results
If pragmatic rehabilitation proves clinically- and cost-effective, we will encourage its implementation as a specialist service within primary care organisations, and will develop educational programmes for primary care health professionals.

Publications

10 25 50

publication icon
Chew-Graham C (2011) Factors influencing engagement of patients in a novel intervention for CFS/ME: a qualitative study. in Primary health care research & development

 
Description NHS Manchester Short-term reserach fellowship (post doctoral)
Amount £18,934 (GBP)
Organisation Manchester Primary Care Trust (PCT) 
Sector Public
Country United Kingdom
Start 03/2009 
End 09/2009
 
Description NHS Sustainability and Flexibility funding
Amount £13,000 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2009 
End 09/2009
 
Description NIHR Research for Patient Benefit
Amount £244,000 (GBP)
Organisation National Institute for Health Research 
Department Research for Patient Benefit
Sector Public
Country United Kingdom
Start 03/2011 
End 03/2014
 
Title Larun individual patient data review 
Description Data from the original RCT have been supplied as part of a Cochrane Individual Patient Data Review and meta-analysis of graded exercise therapy for chronic fatigue syndrome 
Type Of Material Database/Collection of data 
Year Produced 2013 
Provided To Others? Yes  
Impact None yet. The review is still ongoing 
 
Description NHS post-doctoral fellowship 
Organisation Manchester Primary Care Trust (PCT)
Country United Kingdom 
Sector Public 
PI Contribution Revision of patient manual and development of manual for health professionals We revised the patient PR manual based on feedback from patients (during the FINE trial and from members of our service use group) and GPs, making it more user friendly, simplifying the language and have split a large single document into 3 separate workbooks. These will form the basis of material which patients and GPs can use within primary care but will also be shared with local CFS/ME services to ensure that all teams involved in the management of this patient group have access to the same materials.
Collaborator Contribution The short-term fellowship award funded Dr Lisa Riste from 19th April to 25th November at 0.6wte and the aim was to apply for further funding to take the lessons from the FINE trial forward. Our aim was to apply for RfPB funding to develop and evaluate training for primary care professionals to assist in the management of patients with CFS/ME. Service user involvement In order to ensure that service users were involved in the RfPB application we wished to recruit a service user co-applicant. Because of the nature of CFS/ME it was important to ensure that people were not overburdened by this task and so in response to these concerns we have recruited a number of people who expressed interest in this work (but who felt unable to commit to being a sole representative on further funding bids) into a service user forum. This forum comprises a number of service users across the spectrum from newly diagnosed, long standing and recovered, it also covers both men and women, older and younger people, and also includes a carer. This forum have agreed to start meeting formally if the RfPB application is successful and will then be able to act as a steering group to advise us. One of this group has agreed to be the named co-applicant on our RfPB application. Revision of patient manual and development of manual for health professionals We revised the patient PR manual based on feedback from patients (during the FINE trial and from members of our service use group) and GPs, making it more user friendly, simplifying the language and have split a large single document into 3 separate workbooks. These will form the basis of material which patients and GPs can use within primary care but will also be shared with local CFS/ME services to ensure that all teams involved in the management of this patient group have access to the same materials. RfPB application The main aim of the Fellowship was to develop and submit an application for further funding with NHS Manchester as the lead organization.
Impact Application to NIHR for grant under Research for Patient benefit scheme
Start Year 2009
 
Title Pragmatic rehabilitation 
Description Pragmatic rehabilitation is a treatment for CFS/ME. It starts by providing patients with a coherent model of CFS/ME framed in terms of physiological dysregulation, supported by a referenced manual. The model provides the rationale for a collaboratively designed program of rehabilitation, including graded increases in activity, restoration of sleep wake cycles, and relaxation to deal with somatic symptoms of anxiety. 
Type Therapeutic Intervention - Psychological/Behavioural
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2009
Development Status Under active development/distribution
Clinical Trial? Yes
Impact This is the treatment which was tested in our study. 
 
Description Dissemination to British Association for Chronic Fatigue Syndrome/ME (BACME) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact Alison Wearden. PI gave a talk on the findings of the FINE trial to an audience which consisted primarily of health care professionals, but also contained patients, patient-group representatives and academics

Questions after talk and in email correspondence
Year(s) Of Engagement Activity 2010
 
Description Dissemination to health care professionals 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact We invited GPs, practice nurses and clinical leads from the local CFS/ME service in Greater Manchester to hear feedback on the results of the FINE trial and to engage their interest in future development work proposed in an NIHR RfPB bid. This event took place on 19th August 2009

None yet
Year(s) Of Engagement Activity 2009
 
Description Dissemination to local GPs 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Health professionals
Results and Impact Three members of the research team presented findings from the FINE trial to a group of local GPs, at different stages in their careers. About 30 GPs attended.

Some members of the audience expressed interest in our forthcoming RfPB project and willingness to participate.
Year(s) Of Engagement Activity 2010