Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial
Condition: Headaches
MeSH terms: Headache
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Telemedicine, videoconsultation
Intervention type(s): Other
Intervention description(s): We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Headache; Telemedicine; Videoconsultation; Headache-referrals