Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
02/12/2008
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 Leone Ridsdale

ORCID ID

Contact details

Academic Neuroscience Centre
King's College Hospital
King's - Denmark Hill campus
London
SE5 9RS
United Kingdom
+44 020 7848 5150

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00077

Study information

Scientific title

Acronym

Study hypothesis

Epilepsy affects one in 200 people. Their need for information and counselling have not generally been met either in primary or secondary care. Consumer groups have been less effective in drawing attention to gaps in the service than in the case of diabetes, probably due to the stigma attached associated with epilepsy. We have trialled the introduction of clinics in primary care in which a nurse specialist monitored patients and provided information and advice on self-management. The patient feedback was the benefit of this would have been greater earlier, preferably from the time of diagnosis. We propose to offer a randomly selected half of patients who have been newly diagnosed an appointment with a nurse specialist. They will receive a package of information and advice. Patients in the intervention and in the comparison groups will be assessed before and after the intervention using qualitative and quantative methods.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Nervous system diseases: Epilepsy

Intervention

1. Appointment with nurse specialist and receipt of information package and advice
2. Standard care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Increase in patient knowledge; Qualitative data on patient knowledge, coping and satisfaction, as well as questions and gaps perceived in service.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/12/1995

Overall trial end date

30/06/1999

Reason abandoned

Eligibility

Participant inclusion criteria

104 patients newly diagnosed with epilepsy, and antiepileptic drugs initiated.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

104

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

31/12/1995

Recruitment end date

30/06/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Neuroscience Centre
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10961629

Publication citations

  1. Results

    Ridsdale L, Kwan I, Cryer C, Newly diagnosed epilepsy: can nurse specialists help? A randomized controlled trial. Epilepsy Care Evaluation Group., Epilepsia, 2000, 41, 8, 1014-1019.

Additional files

Editorial Notes