Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
29/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Lester

ORCID ID

Contact details

Dept of General Practice
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3760

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

844

Study information

Scientific title

Acronym

Study hypothesis

From the viewpoint of both primary and secondary care, what is the effect of a patient held shared record card on the pattern of service use and satisfaction with medical care for people with long term mental illness, compared to current practice?

Ethics approval

Not provided at time of registration

Study design

Cluster randomised controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Condition

Schizophrenia and other psychoses

Intervention

Randomly selected patients entered on the North Birmingham Community District Mental Health Team's "community team case load census" database will be randomised:
1. Patient-held records
2. Current practice
100 patients will be required for each arm of the study. To avoid contamination bias, patients in the study and control arm will be drawn from different general practices.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Adherence with treatment
2. Loss to follow up
3. Satisfaction with medical care
4. Number of psychiatric admissions/year
5. Length of inpatient stay

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/1997

Overall trial end date

31/07/2001

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with more than 2 years history of schizophrenia or other psychoses, severe personality disorder, or severe neurosis who require long-term supervision.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Dementia, or other brain disorder
2. Alcohol or drug misuse
3. Learning disability
4. 15 years or under
5. 65 year or older.

Recruitment start date

01/11/1997

Recruitment end date

31/07/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive West Midlands (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14694695

Publication citations

  1. Results

    Lester H, Allan T, Wilson S, Jowett S, Roberts L, A cluster randomised controlled trial of patient-held medical records for people with schizophrenia receiving shared care., Br J Gen Pract, 2003, 53, 488, 197-203.

Additional files

Editorial Notes