Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/08/2010
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 Amanda Platts

ORCID ID

Contact details

Parkbury House Surgery
St Peters Street
St Albans
AL1 3HD
United Kingdom
+44 (0)1727 851589
amanda.platts@gp-e82060.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0096067462

Study information

Scientific title

Acronym

Study hypothesis

To determine the impact of providing written patient information on the frequency, duration and type of patient contact with the primary healthcare team.

To establish the views of both patient and primary care staff on the implications of providing written information in terms of patient empowerment, the patients' level of self care, and the patients' confidence in deciding when to consult a health professional.

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

GP practices

Trial type

Other

Patient information sheet

Condition

Not Applicable: Service delivery

Intervention

The study is a cluster randomised trial. Patients will be allocated to one of the intervention arms or the control arm of the trial by the relevant health professional according to the contents of a prepared unmarked envelope.

Patients in the intervention arms will receive a book describing how to best manage by self care or by contact with a health professional a wide range of common illnesses. Information on supplementary sources of health information will also be available. Those in the control group will receive usual care which may include information or other sources of health information.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome measures will be the number of contacts (consultations and telephone calls) between the patient and the primary health care team over a one year period. The length of consultation will be logged using data from the computerised appointment system.

Semi-structured interviews mine the usefulness of the self care book from both patient and practice perspectives.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1998

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

The patients to be involved in the study will be randomly selected households from the population of 16,500 patients registered with the Parkbury House Surgery. 800 patients will be invited to participate in each intervention arm, and all occupants of each household will be included (approximately 10% of households.)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients under the age of 16 will not be used in the random allocation process, and households in which English is not clearly understood will be excluded as the information to be used in the study is available in English only.

Recruitment start date

01/04/1998

Recruitment end date

31/12/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Parkbury House Surgery
St Albans
AL1 3HD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

University/education

Funder name

University of Hertfordshire Research Network (HertNet) / Centre for Research in Primary and Community Care (CRIPACC) (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16162465

Publication citations

  1. Results

    Platts A, Mitton R, Boniface D, Friedli K, Can self-care health books affect amount of contact with the primary health care team? A randomized controlled trial in general practice., Scand J Prim Health Care, 2005, 23, 3, 142-148, doi: 10.1080/02813430510031289.

Additional files

Editorial Notes