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
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
-
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.