Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
07/09/2015
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 Lesley Gowers

ORCID ID

Contact details

Melbury Lodge
Romsey Road
Winchester
SO22 5DG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0022111170

Study information

Scientific title

Study to valuate the potential benefits of a patient information leaflet about driving regulation and mental illness

Acronym

Study hypothesis

Whether a patient information leaflet about driving regulations in mental illness improves patient awareness and knowledge of the rules in comparison to current practice.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental and Behavioural Disorders: Mental disorders

Intervention

1. The study group will receive the leaflet during the first week of admission. Before discharge, a questionnaire will be administered to assess knowledge of driving regulations.
2. The control group will not be given the leaflet but will receive standard advice. The questionnaire will be given to them before discharge.
A score will be ascertain for each patient and the mean score and standard deviation for each group calculated. The results will be subjected to statistical analysis to look for differences between the two groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. To improve consistency of information given to patients
2. To give patients information in a form which enables them to understand and remember the regulations more easily

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/03/2002

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

In-patients of Parklands Hospital, Basingstoke who hold a driving license.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/03/2002

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Melbury Lodge
Winchester
SO22 5DG
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Surrey and Borders Partnership NHS Trust (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

Publication citations

Additional files

Editorial Notes