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 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 criterion outcomes will be evaluated (i.e., those neurocognitive measures such as attention, executive functioning and working memory, that are most closely related to the trained tasks).
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study|
- Feasibility [ Time Frame: Post-study - Baseline to Post-Intervention, approximately 5 to 8-weeks after baseline assessment ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Acceptance is defined by 50% of those approached are able to participate/consent to the study.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793740
|Contact: Taryn Allen, MAemail@example.com|
|Contact: Lindsay Anderson, MAfirstname.lastname@example.org|
|United States, North Carolina|
|Duke Child and Family Study Center||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Taryn Allen, MA 919-681-0040 email@example.com|
|Contact: Lindsay Anderson, MA 919-681-0023 firstname.lastname@example.org|
|Principal Investigator: Melanie Bonner, PhD|
|Principal Investigator:||Melanie J Bonner, PhD||Duke University|