Quality of Life following Adherence Therapy for People Disabled by Schizophrenia and their Carers

ISRCTN	ISRCTN01816159
DOI	https://doi.org/10.1186/ISRCTN01816159
Protocol serial number	EU Contract: QLG4-CT-2001-01734.
Sponsor	King's College London (UK)
Funder	European Union (Action Line: Quality of Life-2000- Public Health). European Union contract no. QLG4-CT-2001-01734.

Submission date: 19/05/2003
Registration date: 19/05/2003
Last edited: 11/07/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Graham Thornicroft
Scientific

P029 Health Services Research Department
Institute of Psychiatry
Kings College London
University of London
De Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 0851
Email	J.Bindman@iop.kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	QUATRO
Study objectives	Adherence therapy will improve quality of life for patients, be cost effective, and reduce carer burden.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schizophrenia
Intervention	Patients will receive 8 sessions of either adherence therapy or health education delivered by a trained therapist in each of the five sites. Fidelity will be maintained by group and individual supervision and monitored by examination of transcripts and recordings of interventions. Adherence therapy Adherence therapy is a pragmatic structured intervention drawing on the work of Kemp et al (1996; 1998) and Gray (2001). It has an emphasis on patients' personal choice and responsibility. Initially the therapist will undertake an assessment of the patient's views of their medication. The therapist and patient will then develop an individually tailored plan of therapeutic activities that they will then undertake. The intervention will conclude with a reassessment of the patients' view of medication. The intervention is manualised. Health education Health education draws on the work on medication education of Macpherson et al (1996) and represents best current practice. Trials are consistent in demonstrating that medication education is largely inert in terms of its effect on compliance. The control intervention is a structured intervention with the aim of increasing patients understanding of treatment. While its function in this trial is to control for therapist time, it is also necessary from an ethical standpoint that the intervention is useful, and perceived to be so by subjects, and without adverse effects. The therapist will begin by assessing patients' knowledge about medication. They will then deliver a set series of educational sessions about schizophrenia and its treatment, which do not use the techniques of the experimental intervention. The sessions are didactic rather than patient centred. The intervention is manualised.
Intervention type	Other
Primary outcome measure(s)	The primary outcome measure for the primary hypothesis is the Mental Component Summary Score (MCS) of the SF-36.
Key secondary outcome measure(s)	Other scales to be measured at baseline and 12 months include the following: Socio-demographic: CSRI-EU Psychopathology: BPRS Quality of Life: MANSA, EQ5D, SF36 Disability: WHO DAS II Clinical status: GAF, Calgary Depression Scale Carers QoL : EQ-EU Insight: SAI-E Drug attitude: DAI, Moriskey Adherence: Adherence scale Treatment: Medication qs from CSSRI-EU Side effects: LUNSERS Clinical course: Clinical course schedule Costs: CSSRI-EU Treatment fidelity will be assessed directly at 3 months: adherence therapists in the study will be asked to tape record sessions with patients in the intervention group, and these will be rated for treatment fidelity (according to the adherence intervention protocol) by the Study Co-ordinating Centre. A random sample of control group sessions will also be recorded and examined for fidelity.
Completion date	28/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key inclusion criteria	1. International Statistical Classification of Diseases and Related Health Problems, Tenth edition (ICD-10) schizophrenia 2. In the judgement of the responsible clinician are in need of maintenance anti-psychotic treatment for at least a year after entry to the study 3. Clear evidence of clinical instability in the previous year, defined by one or more of the following: a. Hospital admission on clinical (mental health) grounds b. A change in anti-psychotic medication c. Increased frequency of contact (planned or actual) d. Indications of clinical instability from relatives or carers e. Indications of clinical instability from clinical team
Key exclusion criteria	1. Patients suffering from moderate or severe learning disabilities concurrent with schizophrenia 2. Patients suffering from organic brain disorders 3. Patients being treated by forensic psychiatric services 4. Dependence on alcohol or illicit substances 5. Unable to speak language of host country to a sufficient standard to receive intervention 6. Involved in other studies which are agreed locally to preclude inclusion 7. Lack of capacity to consent to inclusion
Date of first enrolment	01/01/2002
Date of final enrolment	28/02/2005

Locations

Countries of recruitment

United Kingdom
England
Germany
Italy
Netherlands

Study participating centre

P029 Health Services Research Department

London
SE5 8AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009		Yes	No
Results article	results	25/05/2013		Yes	No