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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Headaches

Intervention / Treatment
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* Other: Telemedicine, videoconsultation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Headache-referrals, Headache, Telemedicine, Videoconsultation