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NCT04678037 · ClinicalTrials.gov registry record · NA
Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study
A NA study of Sickle Cell Disease and Sickle Beta Zero Thalassemia, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04678037: Completed NA study of Sickle Cell Disease and Sickle Beta Zero Thalassemia, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT04678037 is a NA study of Sickle Cell Disease and Sickle Beta Zero Thalassemia that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 40 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04678037, a NA study of Sickle Cell Disease and Sickle Beta Zero Thalassemia, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) that will improve hydroxyurea (HU) adherence among adolescents and young adults with sickle cell disease (SCD). In this proposed study, we intend to test the functionality of a PROs-toolbox feature, which will be integrated into our existing smartphone application platform (SCD-app), over a 24-week period in a cohort of SCD patients and their caregivers.
Primary Outcome
Having an overall completion rate of ≥ 50% for all study participants (Group A and B). This will be reported as a dichotomous outcome, either yes or no. The percentage (%) completion rate will be calculated as the number of PROs assessments completed divided by the number of PROs assessments expected over the study period.
Conditions Studied
Interventions
- BEHAVIORAL PROs assessment using sickle cell disease mobile app (SCD-app)
Study Locations (1)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-04-04 |
| Est. Completion | 2019-07-21 |
| Phase | NA |
What the finished NCT04678037 record still lists
NCT04678037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (86% lower).
The record links to 4 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which PROs assessment using sickle cell disease mobile app (SCD-app) is the first listed.
NCT04678037 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04678037 about?
NCT04678037 is a clinical study titled "Home-based Assessment of PRO Measures in SCD Using A Smartphone App Platform: A Feasibility Study". The overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) that will improve hydroxyurea (HU) adherence among adolescents and young adults with sickle cell disease (SCD). In this proposed ...
What is the current status of trial NCT04678037?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2017-04-04. Estimated completion is 2019-07-21.
What conditions does trial NCT04678037 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia, Sickle Cell Hemoglobin C.
What interventions are being tested in trial NCT04678037?
The interventions under investigation include: PROs assessment using sickle cell disease mobile app (SCD-app) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04678037?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678037 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04678037's enrollment target sits among peer trials
40 124th of 213 higher than 86 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
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