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| Name | Class |
|---|---|
| HDC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active group | Every study participant will actively receive daily text messages asking about their change in health and concomitant medication. |
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| Measure | Description | Time Frame |
|---|---|---|
| To improve AE and concomitant medication reporting | Data collected daily through secure text messaging | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease recall bias | Daily reporting of AEs and concomitant medication changes | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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-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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perseverance Research Center, LLC | Scottsdale | Arizona | 85254 | United States |
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