NCT05442307

Brief Summary

General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control). The change in prescription pattern from before to after the visit is compared between the intervention and control group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

2.1 years

First QC Date

October 6, 2021

Last Update Submit

June 29, 2022

Conditions

Prescription Pattern

Outcome Measures

Primary Outcomes (2)

  • Difference in change of prescription of inhaled corticosteroids and long-acting beta2-agonist (ICS+LABA) before and after educational visit in a six months period

    Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group.

    6-0 months before and 6-12 months after educational visit

  • Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit in a six months period

    Difference in change of number of adult patients with prescriptions on ICS and SABA as monotherapy to adults between asthma-group and placebo-group.

    6-0 months before and 6-12 months after educational visit

Secondary Outcomes (18)

  • Difference in change of prescription of ICS+LABA before and after educational visit in one year

    one year before and one year after educational visit

  • Difference in change of prescription of ICS+LABA before and after educational visit in one year as interrupted time series analysis

    one year before and one year after educational visit

  • Difference in change of prescription of ICS+LABA before and after educational visit in one year for each month

    one year before and one year after educational visit

  • Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year

    one year before and one year after educational visit

  • Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year as interrupted time series analysis

    one year before and one year after educational visit

  • +13 more secondary outcomes

Study Arms (2)

asthma education

EXPERIMENTAL

The general practices in this arm will receive the education visits about asthma.

Behavioral: asthma education

Other education

PLACEBO COMPARATOR

The general practices in this arm will receive an educational visit on another topic (PPI).

Behavioral: Other education

Interventions

asthma educationBEHAVIORAL

A 15 minutes (preferable) one-on-one educational visit about asthma treatment. The main points being: Every person with asthma should be treated with inhaled corticosteroids (ICS). Most patients with asthma should be treated with Bufomix Easyhaler either as needed and/or regularly. Patients should not use short-acting bega2-agonist (SABA) unless they use a medium-ICS-dosis.

asthma education
Other educationBEHAVIORAL

A 15 minutes (preferable) one-on-one educational visit about another topic (NOT asthma).

Other education

Eligibility Criteria

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

You may qualify if:

  • General practices in the capital region of denmark, who owns a regional registration number \[ydernummer\]
  • Want a visit
  • Have time for a visit within the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bispebjerg and Frederiksberg

Copenhagen, Capital Region of Denmark, 2400, Denmark

RECRUITING

Study Officials

  • Jon tt Andersen, MD

    University Hospital Bispebjerg and Frederiksberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon T. T. Andersen, MD

CONTACT

+45 38 63 57 26jon.thor.traerup.andersen@regionh.dk

Dagmar A Dalin, Cand. Pharm.

CONTACT

+45 38 66 53 37dagmar.abelone.dalin@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized placebo controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 6, 2021

First Posted

July 5, 2022

Study Start

October 6, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)