Condition category
Nervous System Diseases
Date applied
05/02/2009
Date assigned
05/03/2009
Last edited
14/06/2016
Prospective/Retrospective
Prospectively 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 Paul Kinnersley

ORCID ID

Contact details

Department of Primary Care and Public Health
Floor 3
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
+44 29 20687638
kinnersley@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3/January 2009

Study information

Scientific title

A randomised controlled trial of a Question Prompt Sheet for patients attending an epilepsy clinic

Acronym

QPS Study

Study hypothesis

To identify whether for patients presenting to an epilepsy clinic use of a question prompt sheet leads to an increase in patients' perceptions of clinician empathy.

Ethics approval

North West Wales Ethics Committee, January 2009, ref: 07/WNo01/42

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Epilepsy

Intervention

The intervention is a Question Prompt sheet. The Prompt sheet briefly explains to patients that it may be helpful for them to consider what questions they want to ask at their consultation before they come to the clinic. It will encourage them to identify questions and to ask these in their consultation. It will provide examples of 'frequently asked questions' that patients may want to ask. The Prompt sheet will be piloted in advance to ensure readability. In addition, the clinicians will receive three one hour training sessions on general communication skills and answering patients' questions.

Both intervention and control patients will get a package providing general information about the epilepsy clinic.

The study materials will be posted to patients two weeks before their appointment at the clinic. Data will be collected when the patients consult and at four weeks after their consultation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient perception of clinician empathy, measured immediately after consultation.

Secondary outcome measures

1. Patient anxiety, measured with the Short Form Spielberger State Anxiety Scale before, immediately after and 4 weeks after the consultation
2. Patient satisfaction, measured immediately after the consultation
3. Patient enablement, measured 4 weeks after the consultation
4. Patient quality of life, measured using the QOL in Epilepsy Scale 4 weeks after the consultation

Overall trial start date

01/04/2009

Overall trial end date

01/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged 16 years and over (either sex) attending the epilepsy clinic

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 participants

Participant exclusion criteria

1. On attending the clinic, they appear unable to understand the study materials (in English or Welsh)
2. Too ill to take part in the study

Recruitment start date

01/04/2009

Recruitment end date

01/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Organisation

Cardiff and Vale NHS Trust (UK)

Sponsor details

University Hospital of Wales
Heath Park
Cardiff
CF14 4XN
United Kingdom

Sponsor type

Government

Website

http://www.cardiffandvale.wales.nhs.uk/

Funders

Funder type

Industry

Funder name

UCB Pharma Ltd (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

Publication citations

Additional files

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.