Effectiveness of a Real Time Data Safety Study Tool

Completed

• Conditions: Study Subjects Currently Enrolled in a Clinical Research Trial

• Registration Number: NCT05553288
• Lead Sponsor: Perseverance Research Center, LLC

Brief Summary

Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.

Detailed Description

This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-20
• Study First Posted: 2022-09-23
• Primary Completion: 2022-10-28
• Status Verified: 2022-11
• Study Completion: 2022-11-05
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 18-85 age inclusive
• Male or Female
• Currently enrolled in an ongoing clinical trial
• Capable of providing informed consent and complying with daily study procedures
• Must be able to receive and respond to text messages through phone provider

Exclusion Criteria

• Subjects not currently involved in a clinical trial
• Subjects who cannot receive text messages
• Unable to comply to the study protocol and study visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To improve AE and concomitant medication reporting	6 weeks	Data collected daily through secure text messaging

Secondary Outcome Measures

Name	Time	Method
Decrease recall bias	6 weeks	Daily reporting of AEs and concomitant medication changes

Trial Locations

Locations (1)

Perseverance Research Center, LLC; 🇺🇸 Scottsdale, Arizona, United States