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

ISRCTN	ISRCTN53469570
DOI	https://doi.org/10.1186/ISRCTN53469570
Protocol serial number	N0022111170
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Surrey and Borders Partnership NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Lesley Gowers
Scientific

Melbury Lodge
Romsey Road
Winchester
SO22 5DG
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Study to valuate the potential benefits of a patient information leaflet about driving regulation and mental illness
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	In-patients of Parklands Hospital, Basingstoke who hold a driving license.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	31/03/2002
Date of final enrolment	30/09/2003

Melbury Lodge

Winchester
SO22 5DG
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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