Effectiveness of a Real Time Data Safety Study Tool (RTD)

Perseverance Research Center

Status: Completed

Conditions: Study Subjects Currently Enrolled in a Clinical Research Trial

Study type: Observational

Funder types: Other

Identifiers

NCT05553288

RTD-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

active group

Description:

Every study participant will actively receive daily text messages asking about their change in health and concomitant medication.