HEIDI Study

• Research type

  Research Study

• Full title

  The Role of the Headache Interactive Diary in Headache Services managing Chronic Migraine

• IRAS ID

  224284

• Contact name

  Gina Kennedy

• Contact email

  gina.kennedy@chsft.nhs.uk

• Sponsor organisation

  South Tyneside and Sunderland NHS FT

• Clinicaltrials.gov Identifier

  TBC, TBC

• Duration of Study in the UK

  0 years, 7 months, 14 days

• Research summary

  Botulinum toxin treatment for chronic migraine is a highly effective therapy for patients with chronic migraine. It is recommended by NICE in a technology appraisal (July 2012)3 for those patients who have tried three prophylactic agents without success and are not overusing analgesic medication. It estimates a 50% reduction of healthcare utilisation as a result. If not effectively treated, chronic migraine leads to many attendances to GP services, A and E departments, and accounts for a high proportion of Neurology OPD appointments1,2. Reducing this healthcare cost by making this drug more widely accessible is therefore considered cost effective.

  Diagnosis of chronic migraine is usually made in a specialist headache clinic on the basis of a good history of more than 15 headache days a month for at least three months, eight days of which should have migrainous features. This relies on an accurate history from the patient, supported by paper headache diaries, both of which can be unreliable.

  A mobile phone app ( HEIDI Headache Interactive Diary ) is proposed which will allow patients to accurately record the following details of each headache episode
  • Headache severity as and when it occurs ( Severe, Moderate , Mild or headache free day )
  • Type of Analgesia taken ( Triptans / Codeine Based or Simple )
  • Number of unplanned hospital or GP visits made in relation to headache which will be prompted for on a monthly basis.
  • A HIT-6 questionnaire which will be mandatory at first registration and prompted for on a monthly basis thereafter.
  • The app will use a visual analogue scale of general health, prompted to be completed by the patient once monthly

  On pushing a button on the phone app information will be passed to a central database available for ongoing review by the consultant. At the hospital a headache diary summary list will show the count of migraine and headache days on a month by month basis, severity of attacks and summarise analgesia taken and number of GP and Hospital visits made. A monthly total score for HIT-6 will also be available.
  Hospital users of the system will be able to enter their own assessment of the number of migraine and headache days per month in addition to those determined from the app headache diary to reflect a baseline level of headache severity that the patient may have become accustomed to and not consider worth reporting.
  • There is no available clinical research data to date on the use of an interactive headache diary app to support management of chronic migraine with botulinum toxin treatment to date.
  • The current study proposes to compare the use of the HEIDI app in managing Botox treatments in chronic migraine to paper diaries.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  19/NW/0765

• Date of REC Opinion

  27 May 2020

• REC opinion

  Further Information Favourable Opinion