Comparing health outcomes in people living with chronic headache (questionnaire study) – substudy of CHESS
| ISRCTN | ISRCTN13180641 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13180641 |
| Secondary identifying numbers | 40104 |
- Submission date
- 22/07/2019
- Registration date
- 03/09/2019
- Last edited
- 02/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 August 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
Contact information
Scientific
Warwick Clinical Trials Unit
Warwick Medical School
University of Warwick
Coventry
CV4 7AL
United Kingdom
| Phone | +44 (0)24 76573243 |
|---|---|
| Chloe.norman@warwick.ac.uk |
Scientific
University of Warwick
Warwick Medical School
Coventry
CV4 7AL
United Kingdom
 ORCID ID |
0000-0002-0309-1708 |
|---|---|
| Phone | +44 (0)2476574664 |
| m.underwood@warwick.ac.uk |
Study information
| Study design | Observational; Design type: Cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Comparing health outcomes in people living with chronic headaches (questionnaire study) |
| 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(s) | 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 |
| 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 |
| 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 study start date | 01/02/2018 |
| Overall study end date | 01/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Total final enrolment | 349 |
| 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 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
- England
- United Kingdom
Study participating centres
Warwick Medical School
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
London
NW1 2PG
United Kingdom
Luton
LU4 0DZ
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Sponsor information
University/education
c/o Mrs Jane Prewett
Address Research Support Services
University of Warwick
Kirby Corner Road
Coventry
CV4 8UW
England
United Kingdom
| Phone | +44 (0)2476522746 |
|---|---|
| wmssponsorship@warwick.ac.uk | |
"ROR" |
https://ror.org/01a77tt86 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V1.2 | 26/02/2019 | 03/09/2019 | No | No |
| Results article | 26/10/2022 | 02/11/2022 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN13180641_PROTOCOL_V1.2_26Feb2019.doc
- Uploaded 03/09/2019
Editorial Notes
02/11/2022: Publication reference added and the total final enrolment was updated accordingly.
13/08/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/07/2020 to 01/08/2020.
2. The intention to publish date has been changed from 01/02/2021 to 01/03/2021.
3. The plain English summary has been updated to reflect the changes above.
20/05/2020: The following changes have been made:
1. The overall trial end date has been changed from 01/12/2020 to 01/07/2020.
2. The intention to publish date has been changed from 01/12/2021 to 01/02/2021.
3. The plain English summary has been updated to reflect the changes above.
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.
