Cognitive Rehabilitation in Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT01793740|
Recruitment Status : Completed
First Posted : February 18, 2013
Last Update Posted : August 20, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Cognitive Impairment||Behavioral: Cogmed||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
These children are enrolled in the Cogmed intervention.
Computer based program that aims to improve children's memory, attention, and processing speed.
Other Name: Cogmed computerized cognitive training
No Intervention: Waitlist
These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.
- Feasibility [ Time Frame: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment ]Feasibility is defined as 75% of subjects completing 80% of the training program.
- Efficacy [ Time Frame: Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment ]Efficacy will be defined by participant performance on cognitive outcome measures including executive functioning outcomes from the Cogstate.
- Acceptance [ Time Frame: After the recruitment period has been completed (approximately 2-years) ]Acceptance is defined by 50% of those approached are able to participate/consent to the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years to 16 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 1) Children with a diagnosis of SCD (all genotypes)
- 2) a T-score ≥75th percentile on either the Metacognition or Executive Composite of the BRIEF; and/or
- 3) a standard score ≥1 standard deviation below the mean (<90) on the tasks of executive function or WM from the Cogstate (mean=100; SD=10)
- 1) Estimated IQ ≤ 75), or motor, visual, or auditory handicap that prevents computer use;
- 2) a diagnosis of depression or a pervasive developmental disorder (by history);
- 3) clinical stroke (via record medical history); or
- 4) non-English fluency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793740
|United States, North Carolina|
|Duke Child and Family Study Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Melanie J Bonner, PhD||Duke University|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
|First Posted:||February 18, 2013 Key Record Dates|
|Last Update Posted:||August 20, 2014|
|Last Verified:||August 2014|
sickle cell disease
Children with sickle cell disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn