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
Sponsored by
About this trial
This is an interventional health services research trial for COVID-19 focused on measuring Health services research, Quality improvement
Eligibility Criteria
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
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
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
Email
marit.tiv@fhi.no
First Name & Middle Initial & Last Name or Official Title & Degree
Atle Fretheim, PhD
Phone
+47 91649828
Email
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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