Cognitive Rehabilitation in Sickle Cell Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01793740
First received: February 14, 2013
Last updated: September 4, 2013
Last verified: August 2013

February 14, 2013
September 4, 2013
October 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01793740 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Cognitive Rehabilitation in Sickle Cell Disease
Cognitive Rehabilitation of Children With Sickle Cell Disease: A Pilot Study

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sickle Cell Disease
  • Cognitive Impairment
Behavioral: Cogmed
Computer based program that aims to improve children's memory, attention, and processing speed.
Other Name: Cogmed computerized cognitive training
  • Experimental: Cogmed
    These children are enrolled in the Cogmed intervention.
    Intervention: Behavioral: Cogmed
  • No Intervention: Waitlist
    These children are enrolled in a waitlist condition, after which they will be offered the opportunity to complete the intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Both
8 Years to 16 Years
No
Contact: Taryn Allen, MA 919-681-0022 taryn.allen@duke.edu
Contact: Lindsay Anderson, MA 919-681-0040 lindsay.anderson@duke.edu
United States
 
NCT01793740
Pro00035303
No
Duke University
Duke University
Not Provided
Principal Investigator: Melanie J Bonner, PhD Duke University
Duke University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP