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Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

Primary Purpose

COVID-19

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Telephone call about vaccination

About this trial

This is an interventional health services research trial for COVID-19 focused on measuring Health services research, Quality improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Belonging to group at risk of severe COVID-19

Exclusion Criteria:

Sites / Locations

Bolteløkka legesenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone call from family physician

Usual care

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05207137

First Posted

December 8, 2021

Last Updated

April 19, 2022

Sponsor

Norwegian Institute of Public Health

Collaborators

City of Oslo, Norway

1. Study Identification

Unique Protocol Identification Number

NCT05207137

Brief Title

Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

Official Title

[In Norwegian]: Samtale Med Fastlegen Som Tiltak for å øke Covid-19-vaksinedekningen

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 3, 2021 (Actual)

Primary Completion Date

April 28, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian Institute of Public Health

Collaborators

City of Oslo, Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

Health services research, Quality improvement

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telephone call from family physician

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Telephone call about vaccination

Intervention Description

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

Primary Outcome Measure Information:

Title

Vaccination status (COVID-19)

Description

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.

Time Frame

3-6 weeks after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Belonging to group at risk of severe COVID-19 Exclusion Criteria: -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marit Tuv, MD

Phone

+47 97566647

marit.tiv@fhi.no

First Name & Middle Initial & Last Name or Official Title & Degree

Atle Fretheim, PhD

Phone

+47 91649828

atle.fretheim@online.no

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Atle Fretheim, PhD

Organizational Affiliation

Norwegian Institute of Public Health

Official's Role

Study Director

Facility Information:

Facility Name

Bolteløkka legesenter

City

Oslo

ZIP/Postal Code

0168

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Søren Sandager Petersen, MD

12. IPD Sharing Statement

Learn more about this trial

Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

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