The CareFile Project: An assessment of the impact of individualised information booklets in patients post stroke

ISRCTN	ISRCTN55373356
DOI	https://doi.org/10.1186/ISRCTN55373356
Protocol serial number	N/A
Sponsor	University Hospital Aintree Research and Development (UK)
Funders	Aintree Trust (UK) - Research and Development, Bristol-Myers Squibb (UK) - Research Grant

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Deborah Lowe
Scientific

c/o Stroke Research Office
University Hospital Aintree
Longmoor Lane
Liverpool
L7 7AL
United Kingdom

Email	debbielowe@hotmail.com

Primary study design	Interventional
Study design	Randomised controlled feasibility trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Potential to improve stroke knowledge following the implementation of an individualised information booklet 2. Assessment of new information tool and stroke knowledge assessment tool
Ethics approval(s)	Approval was obtained from the local Research Ethics Committee
Health condition(s) or problem(s) studied	Stroke
Intervention	Individualised information booklets.
Intervention type	Other
Primary outcome measure(s)	Knowledge of stroke risk factors and secondary prevention.
Key secondary outcome measure(s)	1. Satisfaction with information given 2. Utilisation of CareFile 3. Blood pressure targets
Completion date	01/03/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Confirmed stroke 2. All ages 3. Either sex 4. Patients who are discharged home and who can self complete a questionnaire, or who have a named carer who can do so
Key exclusion criteria	1. Patients with pre-existing cognitive impairment 2. Patients who are discharged to institutionalised care 3. Patients who are discharged home and who cannot complete questionnaires and have no other named carer who can do so
Date of first enrolment	01/04/2000
Date of final enrolment	01/03/2001

c/o Stroke Research Office

Liverpool
L7 7AL
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?
Results article	results	01/01/2007		Yes	No