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RTD: Effectiveness of a Real Time Data Safety Study Tool

Sponsor
Perseverance Research Center, LLC (Other)
Overall Status
Completed
CT.gov ID
NCT05553288
Collaborator
HDC (Other)
20
Enrollment
1
Location
3.2
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects
    Actual Study Start Date :
    Aug 1, 2022
    Actual Primary Completion Date :
    Oct 28, 2022
    Actual Study Completion Date :
    Nov 5, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    active group

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

    Outcome Measures

    Primary Outcome Measures

    1. To improve AE and concomitant medication reporting [6 weeks]

      Data collected daily through secure text messaging

    Secondary Outcome Measures

    1. Decrease recall bias [6 weeks]

      Daily reporting of AEs and concomitant medication changes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Perseverance Research Center, LLC Scottsdale Arizona United States 85254

    Sponsors and Collaborators

    • Perseverance Research Center, LLC
    • HDC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Perseverance Research Center, LLC
    ClinicalTrials.gov Identifier:
    NCT05553288
    Other Study ID Numbers:
    • RTD-01
    First Posted:
    Sep 23, 2022
    Last Update Posted:
    Nov 15, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Perseverance Research Center, LLC
    text messaging, safety, real time data

    Study Results

    No Results Posted as of Nov 15, 2022