Testing Video Information About Mammography Screening

July 14, 2020 updated by: Manja Dahl Jensen, University of Copenhagen

Testing Video Information About Mammography Screening in a Randomized Design

This study examines how video information about mammography screening effect participants knowledge opinions and choice about screening.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted as a single site parallel-arm, 1:1 randomized controlled trial (RCT) through a web-based quantitative survey uploaded in online forums. Participants will be randomized to either the intervention group (video information about mammography screening followed by a survey about mammography screening) or the control group (video information about energy systems followed by the same survey). The survey computer programme will randomly assign each respondent to either the intervention arm or the control arm in the beginning of the survey.

The allocation will be concealed from the researchers. The survey computer programme will deliver the intervention right after randomization. Participants will be aware of the allocation. However, they do not know about the study design. Data analysts will be kept blinded to the allocation.

Choice, knowledge and opinions related to mammography screening will be compared between the control group and the intervention group at one timepoint.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital
      • Copenhagen, Capital, Denmark, 1014
        • Recruiting
        • University of Copenhagen, Section of General Practice
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants eligible for the study includes all men and women age 18-75.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Receives information about mammography screening through a video. The video was developed with the goal of informing about mammography screening in a societal perspective using best available evidence.
Other: Video information about mammography screening
A video informing about mammography screening
Placebo Comparator: Control group
Receives information about energy systems through a video. The video does not contain any information related to mammography screening.
Other: Video information about smart energy systems
A video informing about smart energy systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choice: proportion of participants in favor of mammography screening
Time Frame: One month
The primary outcome in the study is choice. A possible effect of the intervention on choice will be examined by comparing the proportion of participants in favor of screening (on the individual level and societal level respectively) between the intervention arm and the control arm. One question addressing the societal choice and one question addressing the individual choice is included in our questionnaire.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response duration: time
Time Frame: One month
Response duration is registered for all participants in the online survey. Mean response duration will be calculated in both the intervention arm and control arm.
One month
Acceptability of the video: percentage of participants finding the video to be neutral, in favor of or against mammography screening.
Time Frame: One month
Percentages of the participants finding the video to be neutral, in favor of or against mammography screening will be calculated in the intervention arm.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Manja Jensen, MD, Section of General Practice, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Anticipated)

July 30, 2020

Study Completion (Anticipated)

July 30, 2020

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2204MDJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the study is completed, access to study data will be provided by the PI on request.

IPD Sharing Time Frame

Data will be stored until 2050.

IPD Sharing Access Criteria

Data will be provided by the PI on request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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