Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-24 @ 2:27 PM
NCT ID:
NCT04746859
Description:
De-identified participant data will be available for analysis. Data will be shared through secure platforms compliant with PHIPA. Researchers must submit a data access request, including their research proposal, analysis plan, and research ethics board approval.
Types of Data Available: Baseline and follow-up (3-, 6-, and 12-month) surveys, BETTER Health Survey, Prevention Prescription and Goals, and relevant outcomes from electronic medical records.
Other Available Documents: Protocol, Survey Instruments, Interview guides
Applicable Analyses: Health outcomes and behavior change; Economic evaluations; Implementation and process evaluations; Exploratory analyses on effect modifiers and mechanisms of action; Comparative studies on intervention efficacy
Privacy and Confidentiality: All data will be de-identified to protect participant privacy. Data transfer and storage will comply with PHIPA. Data will be securely stored in a database with access limited to authorized personnel.
Study:
NCT04746859
Study Brief:
Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program