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NCT01793740 · ClinicalTrials.gov registry record · NA
Cognitive Rehabilitation in Sickle Cell Disease
A NA study of Sickle Cell Disease and Cognitive Impairment, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01793740 is a NA study of Sickle Cell Disease and Cognitive Impairment that has completed, run by Duke University. The registered enrollment target is 18 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01793740, a NA study of Sickle Cell Disease and Cognitive Impairment, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed. Pilot data will also be collected to establish preliminary efficacy. Twenty-four children meeting initial age and diagnostic criteria will be identified and approached about participation by their attending physician during regularly-scheduled SCD clinic visits. Baseline assessments will include a brief measure of intellectual functioning, a brief cognitive testing battery evaluating processing speed and working memory, in addition to questionnaires regarding behavior and quality of life. Children will then be randomized to the computerized CT program Cogmed (n=12) or a waitlist control (n=12). Participants enrolled in the computerized CT program will be asked to complete 25-sessions of Cogmed over a five to eight week period (3 to 5 sessions per week). Following completion of the program, children and their parents will be asked to return to clinic for a follow-up visit. After a five to eight-week waiting period, children in the waitlist condition will also be asked to return to clinic for a second visit. Following this assessment, participants initially enrolled in the waitlist will be offered an opportunity to participant in the intervention. If interested, they will follow the same intervention protocol described above. These children will return to clinic for a third visit following completion of the intervention. Compliance rate and its confidence interval will be calculated for the overall study population. A t-test for binomial proportion with continuity correction will be used to examine whether the compliance rate is lower than the target. Participants' change in
Conditions Studied
Interventions
- BEHAVIORAL Cogmed
Study Locations (1)
North Carolina
- Duke Child and Family Study Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01793740
The ClinicalTrials.gov registry entry for NCT01793740 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (94% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Cogmed is the first listed.
NCT01793740 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01793740 about?
NCT01793740 is a clinical study titled "Cognitive Rehabilitation in Sickle Cell Disease". The majority of school-age children with sickle cell disease (SCD) experience neurocognitive deficits, even in the absence of stroke. In particular, deficits in attention and working memory have emerged as two of the most common neurocognitive sequelae of SCD. Thus, the goal of the present proposal ...
What is the current status of trial NCT01793740?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2012-10. Estimated completion is 2014-07.
What conditions does trial NCT01793740 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Cognitive Impairment.
What interventions are being tested in trial NCT01793740?
The interventions under investigation include: Cogmed (BEHAVIORAL).
Who is sponsoring clinical trial NCT01793740?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01793740 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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