Trial record 17 of 147 for:    Open Studies | "Anemia, Sickle Cell"

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
  Purpose

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).


Condition Intervention
Sickle Cell Disease
Cognitive Impairment
Behavioral: Cogmed

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 30
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)
Arms Assigned Interventions
Experimental: Cogmed
These children are enrolled in the Cogmed intervention.
Behavioral: Cogmed
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.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793740

Contacts
Contact: Taryn Allen, MA 919-681-0022 taryn.allen@duke.edu
Contact: Lindsay Anderson, MA 919-681-0040 lindsay.anderson@duke.edu

Locations
United States, North Carolina
Duke Child and Family Study Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Taryn Allen, MA    919-681-0040    taryn.allen@duke.edu   
Contact: Lindsay Anderson, MA    919-681-0023    lindsay.anderson@duke.edu   
Principal Investigator: Melanie Bonner, PhD         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Melanie J Bonner, PhD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01793740     History of Changes
Other Study ID Numbers: Pro00035303
Study First Received: February 14, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
sickle cell disease
pediatric
learning disability
cognitive impairment
memory
attention
Children with sickle cell disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Cognition Disorders
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014