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

Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85254
      • Perseverance Research Center, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

-Men and women from 18-85 years of age inclusive, who are currently enrolled in a clinical trial at Perseverance Research Center. All subjects must meet all inclusion and no exclusion criteria to be eligible for enrollment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
active group; Every study participant will actively receive daily text messages asking about their change in health and concomitant medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To improve AE and concomitant medication reporting	Data collected daily through secure text messaging	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease recall bias	Daily reporting of AEs and concomitant medication changes	6 weeks

Collaborators and Investigators

• Sponsor: Perseverance Research Center, LLC
• Collaborators: HDC

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): November 5, 2022

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: text messaging, safety, real time data
• Other Study ID Numbers: RTD-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No