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NCT02857023 · ClinicalTrials.gov registry record · NA
Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease
A NA study of Anemia, Sickle Cell, sponsored by Steven J. Hardy.
- Completed
- Registry status
- NA
- Development phase
- 91
- Enrollment target
- 1
- Study location
NCT02857023: Completed NA study of Anemia, Sickle Cell, sponsored by Steven J. Hardy.
NCT02857023 is a NA study of Anemia, Sickle Cell that has completed, run by Steven J. Hardy. The registered enrollment target is 91 participants, below the 113-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02857023, a NA study of Anemia, Sickle Cell, has completed, sponsored by Steven J. Hardy.
- COMPLETED
- Registry status
- NA
- Development phase
- 91 participants
- Enrollment target
- 1
- Study location
Study Summary
Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.
Primary Outcome
Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).
Conditions Studied
Interventions
- BEHAVIORAL Cogmed RM
Study Locations (1)
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2014-10 |
| Est. Completion | 2018-08 |
| Phase | NA |
What the finished NCT02857023 record still lists
NCT02857023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 113-participant average among 17 other Anemia, Sickle Cell trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Anemia, Sickle Cell appearing as the primary indexed condition, and to 1 intervention - of which Cogmed RM is the first listed.
NCT02857023 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02857023 about?
NCT02857023 is a clinical study titled "Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease". Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive d...
What is the current status of trial NCT02857023?
This trial is currently completed. It is a NA study. The enrollment target is 91 participants. The study started on 2014-10. Estimated completion is 2018-08.
What conditions does trial NCT02857023 study?
This clinical trial studies the following conditions: Anemia, Sickle Cell.
What interventions are being tested in trial NCT02857023?
The interventions under investigation include: Cogmed RM (BEHAVIORAL).
Who is sponsoring clinical trial NCT02857023?
This trial is sponsored by Steven J. Hardy, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02857023 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02857023's enrollment target sits among peer trials
91 10th of 17 higher than 8 of 17 other Anemia, Sickle Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anemia, Sickle Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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