HeadachesVHSNCT02270177
Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial
A study testing Telemedicine, videoconsultation in people with Headaches, run by University Hospital of North Norway at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Headaches
- What is being tested?
- Telemedicine, videoconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neurology, University Hospital of North Norway
Tromsø, Troms, 9038
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Headaches
- Being tested
- Telemedicine, videoconsultation
- Keywords
- Headache, Telemedicine, Videoconsultation, Headache-referrals
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine, videoconsultationOther
We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.
| Study group | Role | What they receive |
|---|---|---|
| Regular consultation | No intervention | Regular headache consultations |
| Videoconsultation | Other | Headache consultations through telemedicine technology Receives: Other: Telemedicine, videoconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of satisfied participants
Are you satisfied with the consultation? Yes/No
Measured: change from baseline at 3 months and 12 months
Secondary outcomes (7)
VAS satisfaction rating scale
Visual analog satisfaction scale 0-10, where 0 = least satisfied and 10 = most satisfied
Measured: 12 months
VAS pain scale
Headache measured by a visual analog scale 0-10, 0= no pain, 10=worst pain
Measured: changes from baseline in VAS at 3 months and 12 months
HIT-6
Headache impact test
Measured: Changes from baseline in HIT 6 at 3 months and 12 months
Job situation/occupation
Job situation/occupation
Measured: 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
Measured: numbers of consultations from baseline and after 12 months
number of pain killers, triptans and other medications for headache
number of medications for headache
Measured: at baseline, after 3 months and after 12 months
headache diagnosis
Headache diagnosis after IHS criteria
Measured: at baseline, after 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for HeadachesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Responsible party
- Sponsor
- Investigators
- Svein I Bekkelund, MD, PHD, Principal investigator, Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270177
- Sponsor's protocol ID
- 2009/1430 REK sør-øst
- Other IDs
- FAS nr: 692, HST959-10
- Acronym
- VHS
- Status last verified
- May 2016
- First submitted
- 2 Oct 2014
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20473702Stovner 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.
PubMed 16643310Stovner 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.
PubMed 18418547Bekkelund 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.
PubMed 11978723Bekkelund 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.
PubMed 12389752Bekkelund 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.
PubMed 17116222Salvesen 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.
PubMed 12890133Bekkelund 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.
PubMed 11604376Cottrell 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.
PubMed 17927645Pryse-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.
PubMed 12139080Headache 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.
PubMed 14979299Bekkelund SI, Muller KI. Video consultation for non-acute headache by neurologist is not inferior to traditional consultations in terms of headache consultation rate at follow-up: post hoc analyses of a randomized controlled trial. Front Neurol. 2026 Apr 7;17:1798381. doi: 10.3389/fneur.2026.1798381. eCollection 2026.
PubMed 42021778Bekkelund 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.
PubMed 34898455Muller 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.
PubMed 28615434Muller 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.
PubMed 27301460
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02270177
- Acronym / sponsor ID
- VHS / 2009/1430 REK sør-øst
- Conditions
- Headaches
- Keywords
- Headache, Telemedicine, Videoconsultation, Headache-referrals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Sep 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular consultation | No intervention | –Regular headache consultations |
| Videoconsultation | Other | Other: Telemedicine, videoconsultationHeadache consultations through telemedicine technology |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine, videoconsultationWe are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches. | Other | Videoconsultation |
Primary outcome
Number of satisfied participants
Time frame: change from baseline at 3 months and 12 months
Are you satisfied with the consultation? Yes/No
7 secondary outcomes
VAS satisfaction rating scale
Time frame: 12 months
VAS pain scale
Time frame: changes from baseline in VAS at 3 months and 12 months
HIT-6
Time frame: Changes from baseline in HIT 6 at 3 months and 12 months
Job situation/occupation
Time frame: changes from baseline in job situation at 3 months and 12 months
numbers of consultations during follow up
Time frame: numbers of consultations from baseline and after 12 months
number of pain killers, triptans and other medications for headache
Time frame: at baseline, after 3 months and after 12 months
headache diagnosis
Time frame: at baseline, after 3 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Background: PubMed 20473702Stovner 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.
- Background: PubMed 16643310Stovner 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.
- Background: PubMed 18418547Stovner 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.
- Background: PubMed 11978723Bekkelund 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.
- Background: PubMed 12389752Bekkelund 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.
- Background: PubMed 17116222Bekkelund 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.
- Background: PubMed 12890133Salvesen 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.
- Background: PubMed 11604376Bekkelund 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.
- Background: PubMed 17927645Cottrell 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.
- Background: PubMed 12139080Pryse-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.
- Background: PubMed 14979299Headache 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.
- Derived from this study: PubMed 42021778Bekkelund SI, Muller KI. Video consultation for non-acute headache by neurologist is not inferior to traditional consultations in terms of headache consultation rate at follow-up: post hoc analyses of a randomized controlled trial. Front Neurol. 2026 Apr 7;17:1798381. doi: 10.3389/fneur.2026.1798381. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svein I Bekkelund, MD, PHD principal investigator
Neurologic department, University Hospital of North-Norway, Tromsø and University of Tromsø, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine, videoconsultation in people with Headaches, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of satisfied participants (time frame: change from baseline at 3 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02270177, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.