Condition category
Circulatory System
Date applied
11/09/2005
Date assigned
17/11/2005
Last edited
15/07/2010
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 Deborah Lowe

ORCID ID

Contact details

c/o Stroke Research Office
University Hospital Aintree
Longmoor Lane
Liverpool
L7 7AL
United Kingdom
debbielowe@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approval was obtained from the local Research Ethics Committee

Study design

Randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Stroke

Intervention

Individualised information booklets.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Knowledge of stroke risk factors and secondary prevention.

Secondary outcome measures

1. Satisfaction with information given
2. Utilisation of CareFile
3. Blood pressure targets

Overall trial start date

01/04/2000

Overall trial end date

01/03/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

01/04/2000

Recruitment end date

01/03/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Stroke Research Office
Liverpool
L7 7AL
United Kingdom

Sponsor information

Organisation

University Hospital Aintree Research and Development (UK)

Sponsor details

University Hospital Aintree
Longmoor Lane
Liverpool
L7 7AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Aintree Trust (UK) - Research and Development

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bristol-Myers Squibb (UK) - Research Grant

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17175561

Publication citations

  1. Results

    Lowe DB, Sharma AK, Leathley MJ, The CareFile Project: a feasibility study to examine the effects of an individualised information booklet on patients after stroke., Age Ageing, 2007, 36, 1, 83-89, doi: 10.1093/ageing/afl145.

Additional files

Editorial Notes