ISRCTN ISRCTN49657745
DOI https://doi.org/10.1186/ISRCTN49657745
Protocol serial number Version 3/January 2009
Sponsor Cardiff and Vale NHS Trust (UK)
Funder UCB Pharma Ltd (UK)
Submission date
05/02/2009
Registration date
05/03/2009
Last edited
14/06/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Kinnersley
Scientific

Department of Primary Care and Public Health
Floor 3, Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom

Phone +44 29 20687638
Email kinnersley@cf.ac.uk

Study information

Primary study designInterventional
Study designSingle centre randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA randomised controlled trial of a Question Prompt Sheet for patients attending an epilepsy clinic
Study acronymQPS Study
Study objectivesTo 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(s)North West Wales Ethics Committee, January 2009, ref: 07/WNo01/42
Health condition(s) or problem(s) studiedEpilepsy
InterventionThe 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 typeOther
Primary outcome measure(s)

Patient perception of clinician empathy, measured immediately after consultation.

Key secondary outcome measure(s)

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

Completion date01/04/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexAll
Target sample size at registration200
Key inclusion criteriaPatients aged 16 years and over (either sex) attending the epilepsy clinic
Key exclusion criteria1. 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
Date of first enrolment01/04/2009
Date of final enrolment01/04/2010

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

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