Effectiveness of a Real Time Data Safety Study Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-11-05

Brief Summary

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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.

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Tumors

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Detailed Description

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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.

Conditions

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Study Subjects Currently Enrolled in a Clinical Research Trial

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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active group

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No