VertigoVERTAPNCT04929444
Training to Improve Vertigo Management in Primary Care
A study testing Training on vertigo in people with Vertigo and Vertigo, Paroxysmal, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Trial summary
Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines. Design: randomized community trial, by clusters (control group -CG- / intervention group -IG-) Scope: 20 PCT (primary care teams)(10 per group) Outcome variables will be: Diagnostic records… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Vertigo, Vertigo, Paroxysmal
- What is being tested?
- Training on vertigo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 20 randomized primary care teams out of the 56 that make up the "Costa de Ponent" Primary Care Department that serve a population of 1.3 million people.
Who cannot join
- Primary care teams in which> 60% of their professionals have received a course on vertigo in the last 5 years will be excluded.
- Primary care teams who are not interested in participating in the study will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.
Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines.
Design: randomized community trial, by clusters (control group -CG- / intervention group -IG-) Scope: 20 PCT (primary care teams)(10 per group) Outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related.
Statistical analysis:Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers
Read the detailed description
Vertigo is a prevalent pathology whose most frequent cause is benign paroxysmal positional vertigo (BPPV). Treatment of this disease are the relocation manoeuvres. Although these manoeuvres are effective in primary care (PC), they are not done routinely. Attention to other causes of vertigo in PC also has a wide margin for improvement. Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines. Design: randomized community trial, by clusters (CG / IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same. Scope: 20 PCT (10 per group) selected from the "Costa de Ponent" Primary Care Directorate of the Catalan Health Institute. Variables: The outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related illnesses during the study period. Other study variables will be characteristics of the professionals (age, sex) and centers (teachers, number of tutors, rural / urban). All the variables will be collected in an aggregated form by computerized data download during the year following the training intervention in the PCT. Statistical analysis: Following the CONSORT Cluster Guide, the baseline comparability of the two study groups will be analyzed to analyze the homogeneity. Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers. Conclusions: Positive results of the study could imply a paradigm shift in the approach to vertigo in primary care, which would be easy to extend to other areas since the most important part of the training course will be done online.
- Conditions
- Vertigo, Vertigo, Paroxysmal
- Being tested
- Training on vertigo
- Keywords
- primary care, vertigo, randomized clinical trial
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on vertigoOther
Online training on vertigo management in primary care with a face-to-face session.
On the one hand, the course will contain theoretical content and clinical cases will be used as the methodology of the course, with feedback paths for each correct or incorrect answer from the students and videos recorded expressly for the course. In addition, there will be a face-to-face session where all participants must perform the diagnostic and therapeutic maneuvers proposed in the course, to evaluate the use of the training and also to standardize the way of doing them for the study
| Study group | Role | What they receive |
|---|---|---|
| Training group | Active comparator | The professionals of the primary care teams that are in Intervention group would receive the training at the beginning of the study Receives: Other: Training on vertigo |
| Common Practice | No intervention | The professionals of the primary care teams that are in Control group will be offered the training after the conclusion of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic records
proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis
Measured: one year
Secondary outcomes (3)
Derivations to otorhinolaryngologist (ENT) and neurologist
Number of referrals made during the study period
Measured: one year
Prescription of antivertiginous medications
Number of prescriptions of betahistine, sulpiride, dimenhydrinate made during the study period
Measured: One year
Days off work
Number of days off work caused by vertigo-related illnesses during the study period
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized community trial, by clusters (CG /IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Instituto de Salud Carlos III
- Responsible party
- Sponsor
- Investigators
- José L Ballve, MD, PHD, Principal investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929444
- Sponsor's protocol ID
- 4R21/003
- Other IDs
- PI19/00736
- Acronym
- VERTAP
- Status last verified
- May 2021
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Patino J, Cunillera-Puertolas O, Sanllorente-Melenchon A, Rando-Matos Y, Villar-Balboa I, Carrillo-Munoz R, Ballve-Moreno JL, Peguero-Rodriguez E. Effectiveness of training on vertigo/dizziness coding in primary care: a community-based cluster-randomized trial. BMC Med Educ. 2026 Jun 9. doi: 10.1186/s12909-026-09645-2. Online ahead of print.
PubMed 42260492Patino JEP, Moreno JLB, Matos YR, Ortega JA, Puertolas OC, Munoz RC, Balboa IV, Compta XG, Agudelo OLA, Munoz SC, Rodriguez VM, Cortes AN, Rodriguez EP. Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP. Trials. 2022 Jul 29;23(1):608. doi: 10.1186/s13063-022-06548-7.
PubMed 35906606
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Training Intervention to Improve the Approach of Patients With Vertigo in Primary Care. VERTAP Clinical Trial.
- ClinicalTrials.gov ID
- NCT04929444
- Acronym / sponsor ID
- VERTAP / 4R21/003
- Conditions
- Vertigo, Vertigo, Paroxysmal
- Keywords
- primary care, vertigo, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC), Instituto de Salud Carlos III
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jun 2021 (actual)
- 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.
Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines.
Design: randomized community trial, by clusters (control group -CG- / intervention group -IG-) Scope: 20 PCT (primary care teams)(10 per group) Outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related.
Statistical analysis:Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers
Detailed description
Vertigo is a prevalent pathology whose most frequent cause is benign paroxysmal positional vertigo (BPPV). Treatment of this disease are the relocation manoeuvres. Although these manoeuvres are effective in primary care (PC), they are not done routinely. Attention to other causes of vertigo in PC also has a wide margin for improvement. Objectives: To verify the effectiveness of a blended course in PC to improve adherence to clinical practice guidelines. Design: randomized community trial, by clusters (CG / IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same. Scope: 20 PCT (10 per group) selected from the "Costa de Ponent" Primary Care Directorate of the Catalan Health Institute. Variables: The outcome variables will be: Diagnostic records (proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis); Derivations to otorhinolaryngologist (ENT) and neurologist; Prescription of antivertiginous medications and Number of days off work caused by vertigo-related illnesses during the study period. Other study variables will be characteristics of the professionals (age, sex) and centers (teachers, number of tutors, rural / urban). All the variables will be collected in an aggregated form by computerized data download during the year following the training intervention in the PCT. Statistical analysis: Following the CONSORT Cluster Guide, the baseline comparability of the two study groups will be analyzed to analyze the homogeneity. Descriptive statistics of all the baseline variables will be carried out and, the differences between groups in the post-intervention outcome variables will be evaluated through the t-test. In the IG, a multivariate logistic regression model will identify response patterns based on the baseline variables of professionals and centers. Conclusions: Positive results of the study could imply a paradigm shift in the approach to vertigo in primary care, which would be easy to extend to other areas since the most important part of the training course will be done online.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized community trial, by clusters (CG /IG), multicenter and open, taking as unit of allocation the primary care team (PCT). The professionals of the PCT that are in IG would receive the training at the beginning of the study and those of the control group will be offered after the conclusion of the same
| Arm | Type | Receives |
|---|---|---|
| Training group | Active comparator | Other: Training on vertigoThe professionals of the primary care teams that are in Intervention group would receive the training at the beginning of the study |
| Common Practice | No intervention | –The professionals of the primary care teams that are in Control group will be offered the training after the conclusion of the study |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 20 randomized primary care teams out of the 56 that make up the "Costa de Ponent" Primary Care Department that serve a population of 1.3 million people.
Key exclusion criteria (2 listed)
- Primary care teams in which> 60% of their professionals have received a course on vertigo in the last 5 years will be excluded.
- Primary care teams who are not interested in participating in the study will be excluded
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 |
|---|---|---|
| Training on vertigoOnline training on vertigo management in primary care with a face-to-face session. On the one hand, the course will contain theoretical content and clinical cases will be used as the methodology of the course, with feedback paths for each correct or incorrect answer from the students and videos recorded expressly for the course. In addition, there will be a face-to-face session where all participants must perform the diagnostic and therapeutic maneuvers proposed in the course, to evaluate the use of the training and also to standardize the way of doing them for the study | Other | Training group |
Primary outcome
Diagnostic records
Time frame: one year
proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis
3 secondary outcomes
Derivations to otorhinolaryngologist (ENT) and neurologist
Time frame: one year
Prescription of antivertiginous medications
Time frame: One year
Days off work
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 42260492Perez-Patino J, Cunillera-Puertolas O, Sanllorente-Melenchon A, Rando-Matos Y, Villar-Balboa I, Carrillo-Munoz R, Ballve-Moreno JL, Peguero-Rodriguez E. Effectiveness of training on vertigo/dizziness coding in primary care: a community-based cluster-randomized trial. BMC Med Educ. 2026 Jun 9. doi: 10.1186/s12909-026-09645-2. Online ahead of print.
- Derived from this study: PubMed 35906606Patino JEP, Moreno JLB, Matos YR, Ortega JA, Puertolas OC, Munoz RC, Balboa IV, Compta XG, Agudelo OLA, Munoz SC, Rodriguez VM, Cortes AN, Rodriguez EP. Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP. Trials. 2022 Jul 29;23(1):608. doi: 10.1186/s13063-022-06548-7.
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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.
José L Ballve, MD, PHD principal investigator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Questions about this trial
What is this clinical trial studying?
A study testing Training on vertigo in people with Vertigo and Vertigo, Paroxysmal, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Peguero, MD. PHD (#34630053772, pegueroeva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic records (time frame: one year). 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 NCT04929444, which also lists 2 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 18 Jun 2021; AzTrials last refreshed its copy on 1 Nov 2026.