Phase
Condition
Sickle Cell Disease
Red Blood Cell Disorders
Treatment
Enhanced Usual Care (EUC)
I-STRONG
Clinical Study ID
Ages 12-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form for adolescents 18 years old andcaregivers' participation
For children <18, informed assent and parental informed consent to participate inthe study
Willingness to comply with all study procedures and lifestyle considerations andavailability for the duration of the study
Males and females; Ages 12-18 years for adolescents; no age limitations forcaregivers
Documented diagnosis of sickle cell disease (any genotype) for adolescents
Adolescent scores at least 3 on the Pediatric Pain Screening Tool
Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cmVisual Analog Scale
Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea,glutamine, voxelotor, crizanlizumab) as defined by not newly initiated orsignificantly increased dosages (mg/kg) in the past 3 months
Speak and read English
Exclusion
Exclusion Criteria:
An adolescent has comorbid medical conditions typically associated with pain butunrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
Adolescent has undergone genetic or hematopoietic stem cell therapy
Presence of a condition(s) or diagnosis, either physical or psychological, orphysical exam finding that precludes participation
Adolescents receiving active treatment (e.g., weekly appointments with a provider)for nonpharmacological therapies (e.g., structured behavioral pain management,physical therapy, or acupuncture program) that overlap with the active phase of thestudy intervention
Study Design
Study Description
Connect with a study center
Connecticut Children's Medical Center
Hartford, Connecticut 06106
United StatesSite Not Available
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia 30329
United StatesActive - Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
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