Conversation With Family Doctor to Increase COVID-19 Vaccine Uptake

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: Telephone call about vaccination

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marit Tuv, MD; Phone Number: +47 97566647; Email: marit.tiv@fhi.no
• Study Contact Backup: Name: Atle Fretheim, PhD; Phone Number: +47 91649828; Email: atle.fretheim@online.no

Study Locations

• Norway
  • Oslo, Norway, 0168
    • Recruiting
    • Bolteløkka legesenter
    • Contact: Søren Sandager Petersen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Belonging to group at risk of severe COVID-19

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Telephone call from family physician; 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; Participants receive phone call from their family physician, where they are invited to ask questions about the COVID-19 vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health
• Collaborators: City of Oslo, Norway
• Investigators: Study Director: Atle Fretheim, PhD, Norwegian Institute of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Anticipated): April 28, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Quality improvement; Health services research
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Cristin-ID: 2526531

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No