Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial (VHS)

Patients' Satisfaction With Telemedicine Versus Traditional Specialist Consultation for Headache. An Open-labeled Randomized Non-inferiority Study Among Patients With Headache Referred to a Neurologic Outpatient Clinic

Headache is a frequent cause of visits to the GPs office, and the investigators have previously shown that this group accounts for about 20 % of patients referred to a general neurologic outpatient clinic.

To our knowledge, no previous study has investigated whether headache consultation through telemedicine provides equal health care outcomes compared to regular visit to the neurologist. If that's the case, a modern interactive health care system may give simpler and cheaper services for patients, saving travelling costs and community expenses. It may possibly also lead to reduced waiting lists, earlier diagnosis and treatment.

This is an open-labeled randomized non-inferiority trial of headache patients referred to a neurologic clinic in North-Norway. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and treating primary headaches. The null hypothesis is that there is no difference in patient satisfaction between the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation.

Participants will be allocated to either a telemedicine consultation or a regular consultation at the neurologic outpatient clinic in the University Hospital of North-Norway, Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. To ensure the best possible representation in the population, our goal is to include at least 70% of all the referred patients that meet the criteria for participation. The randomizations are made through a centralized 8-16 phone line to the research-department in Tromsø, at the University Hospital of North-Norway.

Both primary and secondary endpoints will be assessed in questionnaires sent three and 12 months after the consultation. In addition, the quality of the physicians' referrals and calculations of cost savings by using telemedicine will be evaluated.

The patients' informed consent will always be obtained before data collection. Patients are able to withdraw from the study at any time. Withdrawal will not affect the treatment or follow up. Local research ethics committee (REC) has approved the study.

Study Overview

• Status: Completed
• Conditions: Headaches
• Intervention / Treatment: Other: Telemedicine, videoconsultation

Detailed Description

Epidemiological research shows that over half of Europe's population suffers from headache. Approximately 11% of the population suffers from migraine, over half of the population have tension-type headache, and 4% have chronic daily headaches. There is clear evidence that headaches, and especially migraines, are under- or misdiagnosed. Headache is a frequent cause of visits to the GPs office, and we have previously shown that this group accounts for about 20 % of patients referred to a general neurologic outpatient clinic.

To our knowledge, no previous studies have investigated whether headache consultations through telemedicine provides equal health care outcomes compared to regular visits to the neurologist. If that's the case, a modern interactive health care system may give simpler and cheaper services for patients, saving traveling costs and community expenses. It may possibly also lead to reduced waiting lists, earlier diagnosis and treatment.

This is an open-label randomized non-inferiority study of headache patients referred to our neurologic outpatient clinic. The aim of this study is to determine if video consultations are non-inferior to regular consultations in diagnosing and treating primary headaches. The null hypothesis is that there is no difference in patient satisfaction between the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation. We will allocate participants to either a telemedicine consultation or a regular consultation at the neurologic outpatient clinic in the University Hospital of North-Norway, Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. All diagnoses are given by the most up to date version of The International Classification of Headache Disorders (ICHD). We will strive continuously to include all patients who meet the inclusion and exclusion criteria. To ensure the best possible representation in the population, our goal is to include at least 70% of all the referred patients that meet the criteria for participation in this study. The randomizations are made through a centralized 8-16 phone line to the research-department in Tromsø, at the University Hospital of North-Norway.

We will gather the primary and secondary endpoints from the recruited participants by questionnaires sent three and 12 months after the consultation. In addition, we are going to investigate the quality of the physicians' referrals, peoples' use of medications, alternative therapies as well as calculations of cost savings by using telemedicine.

The patients' informed consent will always be obtained before data collection. Patients are able to withdraw from the study at any time. Withdrawal will not affect the treatment or follow up. Local research ethics committee (REC) has approved the study.

• Study Type: Interventional
• Enrollment (Actual): 402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9038
      • Department of Neurology, University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Females and males ≥16 and ≤65 years of age
• Referred to a neurologist for headache
• No red flags (defined) suggestive of a secondary cause? No known underlying causes of headaches (secondary headaches) according to established criteria
• Referred for diagnostic clarification and / or treatment
• Waiting time ≤ 4 months from the date of the referral
• speaking Norwegian language

Exclusion Criteria:

• Age <16 years or > 65 years of age
• Known underlying cause of the headache or the presence of red flags suggestive of secondary headaches.
• Examined by a neurologist for headaches in a period of 2 years before referral
• Waited longer than 4 months from the date of referral
• Non-Norwegian speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular consultation; Regular headache consultations
Other: Videoconsultation; Headache consultations through telemedicine technology	Other: Telemedicine, videoconsultation; We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of satisfied participants	Are you satisfied with the consultation? Yes/No	change from baseline at 3 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS satisfaction rating scale	Visual analog satisfaction scale 0-10, where 0 = least satisfied and 10 = most satisfied	12 months
VAS pain scale	Headache measured by a visual analog scale 0-10, 0= no pain, 10=worst pain	changes from baseline in VAS at 3 months and 12 months
HIT-6	Headache impact test	Changes from baseline in HIT 6 at 3 months and 12 months
Job situation/occupation	Job situation/occupation	changes from baseline in job situation at 3 months and 12 months
numbers of consultations during follow up	numbers of GP-consultations, hospital consultations and admissions	numbers of consultations from baseline and after 12 months
number of pain killers, triptans and other medications for headache	number of medications for headache	at baseline, after 3 months and after 12 months
headache diagnosis	Headache diagnosis after IHS criteria	at baseline, after 3 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of travelling distances to the neurologic outpatient clinic	travelling distances in kilometers	travelling distance in kilometers for the neurologic consultation (telemedicine versus regular consultation) and the average travelling distance to the GP during the consecutive 11 months
Expenses saved by using telemedicine	Evaluation of the expenses associated with telemedicine compared to regular consultations (travelling expensis, lost earnings, days away from work,	Expenses (travelling, lost income and days absent from work) for the neurologic consultation and the average expenses for GP-consultations during the consecutive 11 months
Number of headache days and headaches	Change in number of headache days per month and number of headahces per month	change in number of headaches from baseline, at 3 months and 12 months
Change in headache feature	Is the headahce bether, worse or the same. Is the headahce more intens, less intens or unchanged.	Change in headache features from baseline, after 3 months and 12 months

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: University of Tromso
• Investigators: Principal Investigator: Svein I Bekkelund, MD, PHD, Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway

Publications and helpful links

General Publications

• Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
• Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
• Stovner LJ, Zwart JA, Hagen K, Terwindt GM, Pascual J. Epidemiology of headache in Europe. Eur J Neurol. 2006 Apr;13(4):333-45. doi: 10.1111/j.1468-1331.2006.01184.x.
• Stovner LJ, Andree C; Eurolight Steering Committee. Impact of headache in Europe: a review for the Eurolight project. J Headache Pain. 2008 Jun;9(3):139-46. doi: 10.1007/s10194-008-0038-6. Epub 2008 Apr 17.
• Bekkelund SI, Albretsen C. Evaluation of referrals from general practice to a neurological department. Fam Pract. 2002 Jun;19(3):297-9. doi: 10.1093/fampra/19.3.297.
• Bekkelund SI, Salvesen R. Patient satisfaction with a neurological specialist consultation for headache. Scand J Prim Health Care. 2002 Sep;20(3):157-60. doi: 10.1080/028134302760234609.
• Bekkelund SI, Salvesen R. Is uncertain diagnosis a more frequent reason for referring migraine patients to neurologist than other headache syndromes? Eur J Neurol. 2006 Dec;13(12):1370-3. doi: 10.1111/j.1468-1331.2006.01523.x.
• Salvesen R, Bekkelund SI. Aspects of referral care for headache associated with improvement. Headache. 2003 Jul-Aug;43(7):779-83. doi: 10.1046/j.1526-4610.2003.03136.x.
• Bekkelund SI, Salvesen R; North Norway Headache Study (NNHS). Are headache patients who initiate their referral to a neurologist satisfied with the consultation? A population study of 927 patients--the North Norway Headache Study (NNHS). Fam Pract. 2001 Oct;18(5):524-7. doi: 10.1093/fampra/18.5.524.
• Cottrell C, Drew J, Gibson J, Holroyd K, O'Donnell F. Feasibility assessment of telephone-administered behavioral treatment for adolescent migraine. Headache. 2007 Oct;47(9):1293-302. doi: 10.1111/j.1526-4610.2007.00804.x.
• Pryse-Phillips W. Evaluating migraine disability: the headache impact test instrument in context. Can J Neurol Sci. 2002 Jun;29 Suppl 2:S11-5. doi: 10.1017/s0317167100001888.
• Bekkelund SI, Muller KI. One-Year Remission Rate of Chronic Headache Comparing Video and Face-to-Face Consultations by Neurologist: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 13;23(12):e30151. doi: 10.2196/30151.
• Muller KI, Alstadhaug KB, Bekkelund SI. A randomized trial of telemedicine efficacy and safety for nonacute headaches. Neurology. 2017 Jul 11;89(2):153-162. doi: 10.1212/WNL.0000000000004085. Epub 2017 Jun 14.
• Muller KI, Alstadhaug KB, Bekkelund SI. Telemedicine in the management of non-acute headaches: A prospective, open-labelled non-inferiority, randomised clinical trial. Cephalalgia. 2017 Aug;37(9):855-863. doi: 10.1177/0333102416654885. Epub 2016 Jun 14.
• Muller KI, Alstadhaug KB, Bekkelund SI. Acceptability, Feasibility, and Cost of Telemedicine for Nonacute Headaches: A Randomized Study Comparing Video and Traditional Consultations. J Med Internet Res. 2016 May 30;18(5):e140. doi: 10.2196/jmir.5221.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): June 14, 2016
• Last Update Submitted That Met QC Criteria: June 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Telemedicine; Headache; Videoconsultation; Headache-referrals
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: 2009/1430 REK sør-øst; FAS nr: 692 (Registry Identifier: Clinical research administrative system (FAS, UNN)); HST959-10 (Registry Identifier: Helse Nord, e-report)