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Cognitive Remediation Intervention to Prepare for Transition of Care

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ClinicalTrials.gov Identifier: NCT05336201
Recruitment Status : Recruiting
First Posted : April 20, 2022
Last Update Posted : July 25, 2022
Sponsor:
Information provided by (Responsible Party):
Donna Murdaugh, University of Alabama at Birmingham

Brief Summary:
Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Cognitive Impairment Adolescent Behavior Self Efficacy Health-Related Behavior Coping Skills Behavioral: CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth) Phase 2

Detailed Description:
Cognitive impairment is a pervasive debilitating feature of sickle cell disease (SCD), with over 50% of children demonstrating early neurodevelopmental delays, ultimately influencing ability for adolescents with SCD to engage in effective decision-making needed for successful transition into adulthood. The negative effect of cognitive impairment on transition to adult self-care is further compounded by health-related disparities and poor social determinants of health. Transition to self-care among youth with SCD may be facilitated by cognitive remediation. One potential avenue to disseminate cognitive-based interventions to disadvantaged neighborhoods is through telehealth administration. This study will examine the efficacy of C-READY on adaptive and self-management skills in youth with SCD, where there is a critical need to enhance self-efficacy/self-care skills for successful transition into adulthood. Additionally, this study overcomes the barriers of transportation that preclude vulnerable patient populations from returning to the clinic for in-person interventions by offering the intervention in their homes via telehealth. C-READY is a manualized, individualized intervention delivered over the course of 4 weeks in 8, 60 minute one-on-one telehealth sessions between the youth and trained therapist. Caregiver involvement and accountability is promoted by weekly phone sessions in between the 8 primary sessions. The emphasis C-READY is on promotion of independence with adaptive skills necessary for transition of care to adult healthcare, such as managing medications, pain management, sleep hygiene, and/or daily health-related routines; the objective is to identify and focus on goals that best promote those skills. Thus, we will conduct a two-arm, wait-listed randomized control trial among 120 patients with SCD (ages 10-18 years), 60 participants per group; half randomized to the intervention arm, and half to the waitlist arm. The primary outcome is transition readiness skills, with secondary outcome measures of cognitive abilities and neuroimaging metrics. We hypothesize that youth with SCD who participate in C-READY will show improvement in transition readiness skills and show greater improvement in cognitive performance. We also hypothesize that participation in C-READY will improve functional brain connectivity and increase compensatory neural mechanisms. In sum, this study will be the first step in developing highly accessible and scalable evidence-based intervention to improve transition of care, enhance self-care, and ultimately improve overall quality of life in youth with SCD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) Intervention: A Randomized Controlled Trial for Adolescents With Sickle Cell Disease to Prepare for Transition of Care
Actual Study Start Date : July 1, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
Self-management and goal-setting cognitive remediation
Behavioral: CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
Manualized cognitive remediation intervention that includes 1) skills-based remediation (metacognitive training), 2) parent training, and 3) cognitive behavioral approaches. Intervention targets self-management and goal-setting skill building to promote independence in activities necessary for transition of care.

Wait-List Control Group
Will receive the same C-READY intervention after a 4-week wait period
Behavioral: CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
Manualized cognitive remediation intervention that includes 1) skills-based remediation (metacognitive training), 2) parent training, and 3) cognitive behavioral approaches. Intervention targets self-management and goal-setting skill building to promote independence in activities necessary for transition of care.




Primary Outcome Measures :
  1. Transition Readiness [ Time Frame: 4-weeks ]
    Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy

  2. Transition Readiness [ Time Frame: 4-months post-intervention ]
    Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy


Secondary Outcome Measures :
  1. Cognitive Assessment [ Time Frame: 4-weeks ]
    A global cognitive deficit score will be calculated that assesses intellectual functioning, working memory, processing speed, attention, language, and executive functioning. The global cognitive deficit score is calculated as an average of test scores and normalized to a scale of 0-5, with 0 indicating normal functioning and 5 indicating severe deficits.

  2. Cognitive Assessment [ Time Frame: 4-months post-intervention ]
    A global cognitive deficit score will be calculated that assesses intellectual functioning, working memory, processing speed, attention, language, and executive functioning. The global cognitive deficit score is calculated as an average of test scores and normalized to a scale of 0-5, with 0 indicating normal functioning and 5 indicating severe deficits.

  3. Neuroimaging [ Time Frame: 4-weeks ]
    Brain scan (MRI) of structural and functional connectivity



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SCD (all genotypes)
  • Active follow-up at Children's of Alabama Hospital
  • Ages 10-18
  • English-speaking

Exclusion Criteria:

  • History of seizures or overt stroke
  • History of Intellectual Disability or Autism Spectrum Disorder
  • Inability to participate in the MRI scan, such as metal implants, neurostimulators, claustrophobia
  • Currently on psychotropic medications

Information from the National Library of Medicine

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): NCT05336201


Contacts
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Contact: Donna Murdaugh, PhD 2056382189 donnamurdaugh@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Murdaugh    205-638-2135      
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Donna Murdaugh, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05336201    
Other Study ID Numbers: 300003655
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: July 25, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Sharing of the data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We will also make our results available to other scientists interested in understanding cognitive outcomes in youth with sickle cell disease, and to avoid unintentional duplication of research. We also hope that the results of this study will lead to future collaboration to further develop approaches to improve transition of care outcomes in adolescents and youth adults with sickle cell disease. Our plan includes presentation at national and international meetings and publications in peer-reviewed medical journals. All publications of these data will contain a statement of data sharing so that other researchers will know of its availability.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn