Clinical trial NCT02270177: Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headaches
Keywords: Headache
Telemedicine
Videoconsultation
Headache-referrals
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2014-10-21
Enrollment: 402
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of satisfied participants
timeFrame: change from baseline at 3 months and 12 months
Secondary outcomes:
measure: VAS satisfaction rating scale
timeFrame: 12 months
measure: VAS pain scale
timeFrame: changes from baseline in VAS at 3 months and 12 months
measure: HIT-6
timeFrame: Changes from baseline in HIT 6 at 3 months and 12 months
measure: Job situation/occupation
timeFrame: changes from baseline in job situation at 3 months and 12 months
measure: numbers of consultations during follow up
timeFrame: numbers of consultations from baseline and after 12 months
measure: number of pain killers, triptans and other medications for headache
timeFrame: at baseline, after 3 months and after 12 months
measure: headache diagnosis
timeFrame: at baseline, after 3 months and 12 months
Other outcomes:
measure: Estimation of travelling distances to the neurologic outpatient clinic
timeFrame: 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
measure: Expenses saved by using telemedicine
timeFrame: 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
measure: Number of headache days and headaches
timeFrame: change in number of headaches from baseline, at 3 months and 12 months
measure: Change in headache feature
timeFrame: Change in headache features from baseline, after 3 months and 12 months
Locations:
city: Tromsø
country: Norway
facility: Department of Neurology, University Hospital of North Norway
state: Troms
Study officials:
affiliation: Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway
name: Svein I Bekkelund, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.