NCT05207137

Brief Summary

The investigators will randomise individuals from family doctors' lists of patients that are at risk of severe Coronavirus Disease 2019 (COVID-19), and that are not registered as having taken the vaccine against the disease. The patients will be randomised to receiving a phone call from their family physician where the participants are given the opportunity to raise questions they might have around vaccination. The investigators will assess whether this has an impact on vaccine uptake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
654

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 3, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 29, 2025

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

December 8, 2021

Last Update Submit

May 22, 2025

Conditions

Keywords

Health services researchQuality improvement

Outcome Measures

Primary Outcomes (1)

  • Vaccination status (COVID-19)

    Change in proportion of participants who are registered in the national vaccination registry, as having received at least one dose of a COVID-19 vaccine.

    3-6 weeks after inclusion

Study Arms (2)

Telephone call from family physician

EXPERIMENTAL

Individuals allocated to the experimental arm will receive a phone call from the their family physician, where they are offered the opportunity to raise questions they might have about the COVID-19 vaccine.

Behavioral: Telephone call about vaccination

Usual care

NO INTERVENTION

Interventions

Participants receive phone call from their family physician, where they are invited to ask questions about the COVID-19 vaccine.

Telephone call from family physician

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Belonging to group at risk of severe COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolteløkka legesenter

Oslo, 0168, Norway

Location

Related Publications (1)

  • Tuv M, Elgersma IH, Furuseth E, Holst C, Helleve A, Fretheim A. GP phone calls to improve COVID-19 vaccine uptake among patients at increased risk of severe COVID-19: a randomised trial. BJGP Open. 2023 Jun 27;7(2):BJGPO.2022.0175. doi: 10.3399/BJGPO.2022.0175. Print 2023 Jun.

    PMID: 36754551BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Atle Fretheim, PhD

    Norwegian Institute of Public Health

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 26, 2022

Study Start

December 3, 2021

Primary Completion

April 28, 2022

Study Completion

June 30, 2022

Last Updated

May 29, 2025

Record last verified: 2022-01

Locations