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

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.

Conditions

• Headaches

Interventions

OTHER

Telemedicine, videoconsultation

We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.

Sponsors & Collaborators

• University of Tromso

  collaborator OTHER

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Svein I Bekkelund, MD, PHD · Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• Norway

Study Locations