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ISRCTN
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ISRCTN75571732
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ClinicalTrials.gov identifier
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Public title
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Towards more effective European Community care for patients with severe psychosis
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Scientific title
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Acronym
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MECCA
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Serial number at source
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QLG5-CT-2002-01938
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Study hypothesis
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The MECCA study is a cluster randomised controlled trial following the same protocol in community mental health teams in six European countries. The trial tests the hypothesis that the new intervention – as compared to current best standard practice - will lead to a better outcome in terms of quality of life, compliance with medication, needs for care, treatment satisfaction, and the quality of the therapeutic relationship between keyworker and patients with psychotic disorders over a one year period. Changes in psychopathology are not hypothesised to differ between the two groups. The research question regarding costs is purely exploratory.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Europe
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Disease/condition/study domain
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Psychosis
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Participants - inclusion criteria
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Inclusion criteria for key workers are a professional qualification in mental
health and a minimum of one-year professional experience in an outpatient setting. Out of the caseload of each key worker patients who fulfil the following criteria will be identified: living in the community and treated as outpatients by community mental health teams; a history of at least 3 months of continuous care in the current service; a diagnosis of functional psychosis according to International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10), i.e. schizophrenia and other psychotic disorders; aged between 18 and 65 years of age; having at least one contact with their key worker every two months; capable of giving informed consent; and sufficient knowledge of the language of the host country.
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Participants - exclusion criteria
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Living in 24 hour supported hostel type of accommodation; severe physical handicap, organic psychiatric illness or primary substance abuse (however, dual diagnosis as such is not an exclusion criterion); expectation of clinicians to discharge the patient from the service within the next 12 months.
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Anticipated start date
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01/07/2002
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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480
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Interventions
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Key workers are randomly assigned to either the intervention or treatment as usual condition. Randomisation of key workers will be stratified by professional background (ASW, CPN, psychiatrist etc.) and by the number of patients within each key worker's caseload consenting to participate. Patients would be asked for informed consent prior to their key worker being randomised. Whilst the control group will receive treatment as usual in line with current best practice, the intervention group will, in addition to treatment as usual, receive an innovative intervention. The key worker asks patients about their subjective quality of life, treatment satisfaction and wishes for additional/different support using a brief questionnaire. The questionnaire (MECCA) consists of satisfaction ratings with eight life domains (satisfaction with mental and physical health, accommodation, job situation, leisure activities, friendships, relationship with family/partner, personal safety) and three aspects of treatment (satisfaction with practical help, psychological help and medication). Each satisfaction item will be rated on a 1 to 7 rating scale and followed by a question on whether the patient wishes for additional/different support in the given area reflecting subjective needs for change. The assessment is completed by the key worker and patient every two months. Key workers will enter patients answers onto a laptop or palm top computer using software specifically designed for the project, with patients’ ratings presented in a user-friendly colour display detailing scores on each outcome measure. It is expected that the results will directly feed into the therapeutic dialogue and be discussed by the patient and key worker together. The discussion is intended to address in particular all areas where the patients expressed dissatisfaction and ratings that have changed since the previous assessment.
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Primary outcome measure(s)
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Outcome in the two groups will be compared in a pre-post-design. The primary outcome is quality of life. To assess objective and subjective quality of life, the Manchester Short Assessment of Quality of Life (MANSA) will be used at baseline and follow-up (12 months).
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Secondary outcome measure(s)
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Subjective outcome criteria include satisfaction with treatment, needs, treatment compliance, assessment of the therapeutic relationship and patient empowerment. Objective outcome criteria are observer rated psychopathology and costs.
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Sources of funding
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European Commission (Contract number: QLG5-CT-2002-01938)
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Trial website
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Publications
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2002 protocol in http://www.ncbi.nlm.nih.gov/pubmed/12451967
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Contact name
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Prof
Stefan
Priebe
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Address
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Unit for Social and Community Psychiatry
Academic Unit
Newham Centre for Mental Health
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City/town
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London
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Zip/Postcode
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E13 8SP
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Country
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United Kingdom
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Tel
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+44 (0)20 7540 4210
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Fax
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+44 (0)20 7540 2976
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Email
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s.priebe@qmul.ac.uk
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Sponsor
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European Commission
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Address
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DGRTD-F5
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City/town
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Brussels
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Zip/Postcode
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B-1049
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Country
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Belgium
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Tel
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+32 2 299 9726
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Fax
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+32 2 295 8220
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Email
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research@cec.eu.int
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Sponsor website:
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http://www.cordis.lu/fp5/
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Date applied
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25/08/2005
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Last edited
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11/09/2009
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Date ISRCTN assigned
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23/09/2005
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