- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277141
The Vitality Mammography Messaging Study (VMS)
March 20, 2024 updated by: Wits Health Consortium (Pty) Ltd
The Vitality Mammography Study - Testing the Effectiveness of a Booking Platform on Receipt of Screening Mammography - a Randomized Controlled Trial.
The investigators will be conducting a randomized controlled trial amongst members of a Wellness Program to test receipt of mammogram using the Whatsapp social media platform and testing various messages.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
The investigators will be conducting a randomised control trial to test the efficacy of WhatsApp messages to increase receipt of mammography amongst eligible women who are members of the Vitality health promotion programme and are also on the Discovery Health Medical Scheme.
The study will test a message that 1) has a link to a platform created by the Radiology Society of South Africa which allow members to select a range of practices to book a mammogram, against 2) a message that gives names and telephone numbers of Radiology practices in a 5 km radius of the members home address, against 3) a group with a link to an online platform as well as telephone numbers of radiology practices, against 4) a group where a standard message reminding to go for mammogram will be sent, but without names and telephone numbers of the radiology practices, against 5) a control group where no messages relating to mammography will be sent.
Study Type
Interventional
Enrollment (Estimated)
6665
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
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa
- University of Witwatersrand
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Females aged 50 to 75 years, who are members of the Discovery Health Medical Plan and who are also members of Vitality and who have not had a screening mammogram in the preceding three years and who have not previously been diagnosed with breast cancer.
Exclusion Criteria:
- CPA Blocks
- If member's address location, based on their Discovery profile, was further than 5km radius to the Radiologist practice
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard message
standard message reminder to screen for breast cancer.
|
Participants will receive standard messaging based on the Cancer Association of South Africa (CANSA) recommendation on breast cancer screening and a reminder to screen for breast cancer.
|
Experimental: Radiology Booking Site Link
Message with an online link to a radiology practice booking site.
|
Participants will receive a reminder to screen for breast cancer with a direct online link to a radiology practice booking site.
|
Experimental: Radiology practice telephone numbers
Message with a list and telephone numbers of radiology practices.
|
Participants will receive a reminder to screen for breast cancer together with a list and telephone numbers of radiology practices
|
No Intervention: Control - no message
Participants will not receive any messaging regarding mammography.
|
|
Experimental: Radiology booking site link and telephone numbers.
Message with a direct online link to a radiology practice booking site and telephone numbers of radiology practices.
|
Participants will receive a reminder to screen for breast cancer with a direct online link to a radiology practice booking site and a list and telephone numbers of radiology practices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of mammography screening rates using WhatsApp
Time Frame: Five months
|
Comparison of mammography screening rates using an online radiology booking platform, a message with a radiology practice number, to a standard message, all delivered by WhatsApp.
|
Five months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adele Walker, Discovery
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)
September 27, 2023
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
October 27, 2023
First Submitted That Met QC Criteria
February 17, 2024
First Posted (Actual)
February 26, 2024
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- M230742
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Anonymized data will be shared with Wits collaborators
IPD Sharing Time Frame
February 2024 and data will be available until February 2025
IPD Sharing Access Criteria
Only select individuals will have access to the data.
Data will be password protected.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
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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