Towards more effective European Community care for patients with severe psychosis
| ISRCTN | ISRCTN75571732 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75571732 |
| Secondary identifying numbers | QLG5-CT-2002-01938 |
- Submission date
- 25/08/2005
- Registration date
- 23/09/2005
- Last edited
- 04/10/2018
- 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 Stefan Priebe
Scientific
Scientific
Unit for Social and Community Psychiatry
Academic Unit
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
| Phone | +44 (0)20 7540 4210 |
|---|---|
| s.priebe@qmul.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Towards more effective European Community care for patients with severe psychosis |
| Study acronym | MECCA |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Psychosis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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). |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2002 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 480 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 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. |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Unit for Social and Community Psychiatry
London
E13 8SP
United Kingdom
E13 8SP
United Kingdom
Sponsor information
European Commission
Other
Other
DGRTD-F5
Brussels
B-1049
Belgium
| Phone | +32 2 299 9726 |
|---|---|
| research@cec.eu.int | |
| Website | http://www.cordis.lu/fp5/ |
"ROR" |
https://ror.org/00k4n6c32 |
Funders
Funder type
Other
European Commission (Contract number: QLG5-CT-2002-01938)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2002 | Yes | No | |
| Results article | results | 01/11/2007 | Yes | No |
Editorial Notes
04/10/2018: Publication reference added.
