NCT04929444

Brief 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 (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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 18, 2021

Status Verified

May 1, 2021

Enrollment Period

Same day

First QC Date

June 7, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

primary carevertigorandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Diagnostic records

    proportion of nonspecific diagnoses such as dizziness and vertigo, with respect to specific diagnoses such as BPPV, vestibular neuritis

    one year

Secondary Outcomes (3)

  • Derivations to otorhinolaryngologist (ENT) and neurologist

    one year

  • Prescription of antivertiginous medications

    One year

  • Days off work

    One year

Study Arms (2)

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

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

Interventions

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

Training group

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Patino 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.

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José L Ballve, MD, PHD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Peguero, MD. PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 18, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2021

Study Completion

December 31, 2022

Last Updated

June 18, 2021

Record last verified: 2021-05