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

NCT02270177 | Completed

• 3 other identifiers: 2009/1430 REK sør-østFAS nr: 692HST959-10
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

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.

Conditions

Headaches

Keywords

Headache; Telemedicine; Videoconsultation; Headache-referrals

Outcome Measures

Primary Outcomes (1)

• Number of satisfied participants

  Are you satisfied with the consultation? Yes/No

  change from baseline at 3 months and 12 months

Secondary Outcomes (7)

• VAS satisfaction rating scale

  12 months

• VAS pain scale

  changes from baseline in VAS at 3 months and 12 months

• HIT-6

  Changes from baseline in HIT 6 at 3 months and 12 months

• Job situation/occupation

  changes from baseline in job situation at 3 months and 12 months

• numbers of consultations during follow up

  numbers of consultations from baseline and after 12 months

Other Outcomes (4)

• Estimation of travelling distances to the neurologic outpatient clinic

  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

  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 headaches from baseline, at 3 months and 12 months

Study Arms (2)

Regular consultation

NO INTERVENTION

Regular headache consultations

Videoconsultation

OTHER

Headache consultations through telemedicine technology

Other: Telemedicine, videoconsultation

Interventions

Telemedicine, videoconsultation OTHER

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

Videoconsultation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead
• University of Tromso: collaborator

Study Sites (1)

Department of Neurology, University Hospital of North Norway

Tromsø, Troms, 9038, Norway

Location

Related Publications (15)

• 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.

  PMID: 20473702 BACKGROUND

• 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.

  PMID: 16643310 BACKGROUND

• 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.

  PMID: 18418547 BACKGROUND

• 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.

  PMID: 11978723 BACKGROUND

• 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.

  PMID: 12389752 BACKGROUND

• 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.

  PMID: 17116222 BACKGROUND

• 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.

  PMID: 12890133 BACKGROUND

• 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.

  PMID: 11604376 BACKGROUND

• 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.

  PMID: 17927645 BACKGROUND

• 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.

  PMID: 12139080 BACKGROUND

• 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.

  PMID: 14979299 BACKGROUND

• 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.

  PMID: 34898455 DERIVED

• 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.

  PMID: 28615434 DERIVED

• 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.

  PMID: 27301460 DERIVED

• 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.

  PMID: 27241876 DERIVED

MeSH Terms

Conditions

Headache

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Svein I Bekkelund, MD, PHD

  Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 21, 2014
• Study Start: September 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 14, 2016

Record last verified: 2016-05

Locations

NO (1)