Condition category
Nervous System Diseases
Date applied
22/07/2019
Date assigned
03/09/2019
Last edited
05/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic headache is a major source of pain and disability worldwide. The focus of current research is on finding interventions that are clinically effective and cost-effective with the potential to alleviate pain and disability and improve the quality of life of sufferers. Conducting high-quality research into what works best for a given health condition requires an understanding of the impact of alternative strategies on health and health-related quality of life (HRQoL) outcomes. Assessment of health outcomes in general and HRQoL in particular can, however, be challenging in patients living with frequent chronic headaches. Patients may only be affected on some days, when their health state may be classed as very poor – perhaps for a few hours only. Standard measures of HRQoL, such as the EuroQoL 5-Dimensional (EQ-5D) questionnaire that assesses health status on the day of completion, may therefore not provide adequate data in this context. More headache-specific measures may be preferable as they are likely to be responsive to headache symptoms and their impact on patients’ health and HRQoL. This study, therefore, aims to develop methods to predict the HRQoL of chronic headache patients based on responses to more responsive headache-specific questionnaires, such as the Headache Impact Test (HIT-6).

Who can participate?
Patients aged 18 or over attending an outpatient headache clinic for treatment and or management of headache symptoms

What does the study involve?
Participants are recruited from outpatient headache clinics and asked to complete a one-off questionnaire about their headache and its impact on their health and HRQoL. The data collected is used to develop methods for converting responses from headache-specific measures, such as HIT, to generic HRQoL life measures, such as the EQ-5D. Generic HRQoL measures permit outcomes to be expressed in terms of quality-adjusted life years, which provide a common scale for comparing the effectiveness of interventions across different health conditions.

What are the possible benefits and risks of participating?
There is no direct benefit to individual participants but the results should help researchers to better understand the health needs of people living with frequent headaches and may help to develop better interventions to meet the needs of patients. No risks are expected by taking part in this study. However, a participant may find a question distressing or upsetting whilst completing the questionnaire, and they are advised to speak to either a member of the clinical team for help and advice or contact the study team.

Where is the study run from?
1. University of Warwick
2. University Hospitals Coventry and Warwickshire NHS Trust
3. University College London Hospitals NHS Foundation Trust
4. Luton and Dunstable University Hospital NHS Foundation Trust
5. Royal Free London NHS Foundation Trust
6. St George's University Hospitals NHS Foundation Trust
7. University Hospitals Of North Midlands NHS Trust

When is the study starting and how long is it expected to run for?
February 2018 to December 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Chloe Norman
Chloe.norman@warwick.ac.uk
2. Prof. Martin Underwood
m.underwood@warwick.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Chloe Norman

ORCID ID

Contact details

Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 (0)24 76573243
Chloe.norman@warwick.ac.uk

Type

Scientific

Additional contact

Prof Martin Underwood

ORCID ID

http://orcid.org/0000-0002-0309-1708

Contact details

University of Warwick
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
+44 (0)2476574664
m.underwood@warwick.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

40104

Study information

Scientific title

Comparing health outcomes in people living with chronic headaches (questionnaire study)

Acronym

Study hypothesis

Chronic headache is a major source of pain and disability worldwide. The focus of current research is on finding interventions that are clinically effective and cost-effective with the potential to alleviate pain and disability and improve the quality of life of sufferers. Conducting high-quality research into what works best for a given health condition requires an understanding of the impact of alternative strategies on health and health-related quality of life (HRQoL) outcomes. Assessment of health outcomes in general and HRQoL in particular can however be challenging in patients living with frequent chronic headaches. Patients may only be affected on some days, when their health state may be classed as very poor – perhaps for a few hours only. Standard measures of HRQoL, such as the EuroQoL 5-Dimensional (EQ-5D) questionnaire that assesses health status on the day of completion, may therefore not provide adequate data in this context. More headache-specific measures may be preferable as they are likely to be responsive to headache symptoms and their impact on patients’ health and HRQoL. This study therefore aims to develop methods to predict the HRQoL of chronic headache patients based on responses to more responsive headache-specific questionnaires, such as the Headache Impact Test (HIT-6).

Ethics approval

Approved 29/05/2019, South Birmingham REC (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; Tel: +44 (0)2071048107;
Email: nrescommittee.westmidlands-southbirmingham@nhs.net), ref: 19/WM/0134

Study design

Observational; Design type: Cross-sectional

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

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

Condition

Chronic headache

Intervention

Participants will be recruited from outpatient headache clinics and asked to complete a one-off questionnaire about their headache and its impact on their health and HRQoL. The data collected will be used to develop methods for converting responses from headache-specific measures, such as HIT, to generic HRQoL life measures, such as the EQ-5D. Generic HRQoL measures permit outcomes to be expressed in terms of quality-adjusted life years, which provide a common scale for comparing the effectiveness of interventions across different health conditions. The study will contribute to the understanding of outcomes measurement in this population and help inform to select measures for future headache studies.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Headache-specific quality of life measured using HIT-6 and CHQLQ at a single timepoint

Secondary outcome measures

Measured by a questionnaire at a single timepoint:
1. Generic quality of life measured using EQ-5D-5L and SF-12
2. Mental health assessed using HADS

Overall trial start date

01/02/2018

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or over attending an outpatient headache clinic for treatment and or management of headache symptoms. Patients have to have headache symptoms for 15 of more days of the month for at least 3 consecutive months to be classified as chronic headache
2. Able and willing to comply with the study procedures and give informed consent
3. Able to understand English and complete the questionnaire booklet

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

Participant exclusion criteria

1. Unable to understand or complete questionnaire booklet in English
2. Have an underlying serious mental illness that may impair their ability to understand and complete the study questionnaire

Recruitment start date

09/09/2019

Recruitment end date

03/04/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Warwick Clinical Trials Unit Warwick Medical School University of Warwick Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Walsgrave General Hospital Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

Luton and Dunstable University Hospital NHS Foundation Trust
Lewsey Road
Luton
LU4 0DZ
United Kingdom

Trial participating centre

Royal Free London NHS Foundation Trust
Royal Free Hospital Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

St George's University Hospitals NHS Foundation Trust
St George's Hospital Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

University Hospitals Of North Midlands NHS Trust
Newcastle Road
Stoke-on-Trent
ST4 6QG
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

c/o Mrs Jane Prewett
Address Research Support Services
University of Warwick
Kirby Corner Road
Coventry
CV4 8UW
United Kingdom
+44 (0)2476522746
wmssponsorship@warwick.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: NF-SI-0616-10103 - Prof. Petrou

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer-reviewed scientific journals
2. Conference presentation
3. Publication on website
4. Other publication
5. Submission to regulatory authorities
6. A summary of results will be provided to participants in the study, to the charity partners and via the University of Warwick Clinical Trials Unit webpage

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

01/12/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/09/2019: The recruitment start date has been changed from 01/09/2019 to 09/09/2019. 03/09/2019: Uploaded protocol Version 1.2, 26 February 2019 (not peer reviewed). 22/07/2019: Trial's existence confirmed by the NIHR.