Condition category
Signs and Symptoms
Date applied
16/12/2015
Date assigned
16/12/2015
Last edited
01/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Plain English summary under review.

Trial website

Contact information

Type

Public

Primary contact

Miss Kimberley White

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19707

Study information

Scientific title

Chronic Headache Education and Self ­management Study (CHESS)

Acronym

CHESS

Study hypothesis

The aim of this study is to design and test a self-management support programme for people living with chronic headache (the CHESS Intervention).

Ethics approval

West Midlands – Black Country Research Ethics Committee, 11/06/2015, ref: 15/WM/0165

Study design

Non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Primary Care; Subtopic: Primary Care; Disease: All Diseases

Intervention

As part of the feasibility study we will develop and evaluate an education and self-management support intervention for the management of chronic headaches, specifically, migraine, TTH and MOH. The design of the intervention will be informed by systematic reviews on the lived experience of chronic headache, prognostic factors for people living with chronic headache, and style and content of intervention programmes.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Headache specific outcome measure collected by self-completed postal questionnaire.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/01/2016

Overall trial end date

01/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able and willing to comply with the study procedures and informed consent is obtained
2. Aged 18 years or over
3. Chronic headache, defined as headache for 15 or more days per month for at least three months
4. Fluent in written and spoken English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 170; UK Sample Size: 170

Participant exclusion criteria

1. Unable to attend treatment programme
2. No access to a telephone
3. Has an underlying serious psychiatric or psychological disorder that precludes participation in the group intervention
4. Known secondary cause of headache other than medication overuse headache; e.g. primary or secondary brain tumour
5. Is currently participating in another clinical trial (with an unregistered medicinal product), or less than 90 days have passed since completing participation in such a trial

Recruitment start date

25/01/2016

Recruitment end date

01/07/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University of Warwick

Sponsor details

University House
Kirby Corner Road
Warwickshire
CV4 7AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of a number of papers in peer reviewed journals, as well as dissemination of study results at national and international conferences.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes