Working...

Study Detail

Study ID 1005
Name Sickle Cell Disease Implementation Consortium Registry
Contact Email byk@rti.org
Acronym SCDIC Registry
Period ongoing
Design Registry Study
Study PI Barbara Kroner
Institution RTI International
URL https://scdic.rti.org/
CTGovID NA
Funding Agency NHLBI
Grant Number 1U24HL133948-01
Overview The Sickle Cell Disease Implementation Consortium (SCDIC) is the first research program to use implementation science to identify and address barriers to quality care in SCD. Patients enrolled in the implementation research studies may be selected from the SCD Registry. The Registry is designed during Year 1 and begins recruitment in Year 2. The goal is to enroll at least 2,400 patients (300 per Center) between the ages of 15 and 45 years by the end of January 2019 or the time that recruitment for the implementation research studies begins. To achieve these goals, the Registry will:a. Develop standard data collection tools and methods which will be used to characterize the SCD population leading to the development and implementation of research studies;b. Identify gaps in research;c. Conduct data queries and analyze data collected;d. Provide access to these resources to Registry investigators who are interested in advancing the understanding of the SCD population; ande. Publish and disseminate results.
Focus Areas 1. Pregnancy/Fertility
2. Acute/Chronic Pain
3. Organ Function
4. Hydroxyurea vs. Non-Hydroxyurea Patients and SCD Diagnosis Comparisons
5. Adherence/Access to Care
Outcomes 1. SCD Complications/Co-morbidities
2. SCD Treatment
3. SCD Access to Care
4. SCD Quality of life and Patient Reported Outcomes
Data Location RTI International
Biospecimen Available N/A
Data Consent Consent form includes statement that de-identified data will be shared
Biospecimen Consent No sample
Contact Consent Yes, with permission on consent
Genomic Data No
Age Range 0-17
No. Participants 2436
Inclusion Criteria 1. Age 15 years up to and including 45 years
2. English speaking
3. Confirmed SCD diagnosis. Confirmed is defined as supported by documentation in the medical record of a positive test for one of the following: Hb SS, Hb SC, Hb Sß-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, Hb SF. If no medical record is available, the enrolling Center may conduct its own laboratory test as confirmation.
4. Willing and cognitively able to give informed consent and complete the Patient Enrollment Survey
Exclusion Criteria 1. Unwilling or unable to give consent/assent or complete the Patient Enrollment Survey
2. Sickle cell trait (i.e., Hb AS)
3. Successful bone marrow transplant
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease p1f1q03
p1f1q03a
p1f5q4
p1f6q00_c
SCD_DIAG
SCD_TYPE
Data ElementVariables
Cancer p1f1q62
p1f1q62a1_1
p1f1q62a1_2
p1f1q62a1_3
p1f1q62a1_4
Data ElementVariables
Aneurysm
Cardiac Failure p1f5q28f
Cardiovascular Problem p1f1q46
p1f1q46_1
p1f1q46b
p1f1q46b_1
p1f5q28g
p2f1q16f
p2f1q16g
Heart Problem p1f1q40b
p1f1q40b_1
p1f1q41
p1f1q41_1
Data ElementVariables
Gastrointestinal Problem p1f1q44
p1f1q44_1
Hepatitis
Liver Problem p2f1q16k
Data ElementVariables
Diabetes Mellitus p1f1q56
p1f1q56_1
p1f5q28j
p2f1q16j
Endocrine Problem
Data ElementVariables
Genitourinary Problem p1f8label2
p1f8q02_a
p1f8q02_a2
p1f8q02_b
p1f8q02_b2
p1f8q02_c
p1f8q02_d
p1f8q02_e
p1f8q02_e2
Kidney Problem p1f1q35
p1f1q35_1
p1f1q36
p1f1q36_1
p1f1q36a
p1f1q36a_1
p1f5q28b
p1f8label1
p1f8q01_a
p1f8q01_a2
p1f8q01_b
p1f8q01_b2
p1f8q01_c
p1f8q01_d
p1f8q01_e
p1f8q01_e2
p1f8q04a
p1f8q04b
p1f8q04e
p1f8q04e_a
p1f8q04e_b
p1f8q04f
p1f8q04f_a
p1f8q04f_c
p2f1q16b
Priapism p1f1q37
p1f1q37_1
p1f4q10
Renal Dialysis History p1f8q04c
p1f8q04d
Data ElementVariables
Fever
HIV Infection
Immune Problem p1f1q47
p1f1q47_1
Infection p1f1q50
p1f1q50_1
p1f1q51
Vaccination
Data ElementVariables
Sarcoidosis
Spleen Problem p1f1q45
p1f1q45_1
p1f1q45a
p1f1q45a_1
p1f1q45b
p1f1q45b_1
p1f1q45c
p1f1q45c_1
p1f5q30
p2f1q15
Data ElementVariables
Adverse event
Death p1f7q03
p1f7q04
p1f7q05
p1f7q05a
p1f7q05b
p1f7q06
p1f7q06a1
p1f7q06a1_13
p1f7q06a1_14
p1f7q06a1_15
p1f7q06a2
p1f7q06a2_13
p1f7q06a2_14
p1f7q06a2_15
p1f7q07
Disability Status
Hospitalization
Medical Event
Serious Adverse Event
Data ElementVariables
Medical History p1f1q52
p1f1q52_1
p1f1q52a
p1f1q52a_1
p1f1q52b
p1f1q52b_1
p1f1q52c
p1f1q52c_1
p1f1q52d
p1f1q52d_1
p1f1q52e
p1f1q52e_1
p1f1q52f
p1f1q52f_1
Data ElementVariables
Anxiety p1f1q59
p1f1q59_1
Depression p1f1q60
p1f1q60_1
p1f5q38
p1f5q39
p1f5q39a
p1f5q39b
p2f1q33a
p2f1q33b
p2f1q33c
p2f1q33d
p2f1q33e
p2f1q33f
p2f1q33g
p2f1q36a
p2f1q36b
Emotional Health p1f5q37a
p1f5q37b
p1f5q37c
p1f5q37d
p1f5q37e
p1f5q37f
p1f5q37g
Mental status
Psychiatric Disorder p1f1q61
p1f1q61_1
p1f1q61_2
Data ElementVariables
Musculoskeletal Problem p1f5q28d
p2f1q16d
Osteomyelitis p1f1q34
p1f1q34_1
Osteonecrosis p1f1q32
p1f1q32_1
p1f1q32a
p1f1q32a_1
p1f1q32b
p1f1q32b_1
p1f1q32c
p1f1q32c_1
Rheumatic Diseases p1f1q48
p1f1q48_1
p1f1q49
p1f1q49_1
Data ElementVariables
Behavior
Cognition p1f5q35a
p1f5q35b
p1f5q35c
p1f5q35d
p1f5q36a
p1f5q36b
p1f5q36c
p1f5q36d
p2f1q35a
p2f1q35b
p2f1q35c
p2f1q35d
Developmental
Motor
Sensation
Data ElementVariables
Meningitis
Neurologic Event p1f1q38a
p1f1q38a_1
p1f1q38b
p1f1q38b_1
p1f1q39
p1f1q39_1
Seizure
Stroke p1f1q38
p1f1q38_1
p1f1q38d
p1f1q38d_1
p1f5q28h
p2f1q16h
Transient Ischemic Attack p1f1q38c
p1f1q38c_1
Data ElementVariables
Nutritional and Metabolic p1f1q57
p1f1q57_1
Data ElementVariables
Ocular Problem
Sickle Retinopathy p1f1q55
p1f1q55_1
p1f5q28c
p2f1q16c
Data ElementVariables
Abdominal Pain
General Pain p1f1q58
p1f1q58_1
p1f5q12a
p1f5q12b
p1f5q13a
p1f5q13b
p1f5q14a
p1f5q14b
p2f1q_duke1
p2f1q_duke3
p2f1q_duke4
p2f1q08a
p2f1q08b
p2f1q09a
p2f1q09b
p2f1q10a
p2f1q10b
p2f1q11
Headache
Management p1f1q15_2
p1f1q15_3
p1f1q16_2
p1f1q16_3
p1f1q17_3
p1f1q17_4
Pain Attack fp1f5q06
p1f5q10
p1f5q11
p1f5q7
p1f5q8
p1f5q9
p2f1q03
p2f1q04
p2f1q05
p2f1q07
Skeletal and Joint Pain p1f1q33
p1f1q33_1
Data ElementVariables
Birth Outcome
Gestational Age
Menstruation
Pregnancy p1f3q01
p1f3q02
p1f3q03_1
p1f3q04_1
p1f3q08_1
p1f3q09_1
p1f3q09a_1r
p1f3q10_1
p1f3q11_1
p1f3q11a_1
p1f3q12_1
p1f3q12a_1
p1f3q13
p1f3q14
p1f3q15
p1f3q16
p1f3q17
p1f4q03_1
p1f4q04_1
p1f4q07a_1r
p1f4q08_1
p1f4q09_1
p1f4q09a_1
Reproductive Behavior p1f3q05_1
p1f3q06_1
p1f3q07_1
p1f4q01
p1f4q02
p1f4q05_1
p1f4q06_1
p1f4q07_1
p1f4q11
p1f4q12
p1f4q13
p1f4q14
Data ElementVariables
Acute Chest Syndrome p1f1q42
p1f1q42_1
p1f1q42_2
p2f1q16a
Asthma p1f1q43
p1f1q43_1
p1f5q28i
p2f1q16i
Lung Disease p1f1q40
p1f1q40_1
p1f1q40a
p1f1q40a_1
p1f1q46a
p1f1q46a_1
p1f5q28a
p1f5q28e
p2f1q16e
Other Respiratory Problem p1f1q53
p1f1q53_1
Data ElementVariables
Skin Problem p1f1q54
p1f1q54_1
p1f5q29
p2f1q16l
Data ElementVariables
Sleep Problem p1f5q34a
p1f5q34b
p2f1q32a
p2f1q32b
Data ElementVariables
Cardiovascular
Digestive
Genitourinary
Lymphatic p1f1q45d
p1f1q45d_1
Musculoskeletal
Ocular
Respiratory
Surgery History
Data ElementVariables
Address
Age p1f5q3
Ethnic Group p1f5q41
p1f6q03
Gender p1f5q40
p1f6q04
Language p1f5q43
National Origin
Nuclear Family
Race p1f5q42
p1f6q02
Data ElementVariables
Community
Individual p2f2q01
p2f2q01a
p2f2q02
p2f2q02a
Data ElementVariables
Annual Income p1f5q46
Education p1f5q47
Employment Status p1f5q48
p1f5q48a
Household p1f5q45a
p1f5q45b
Insurance p1f1q63
p1f1q63a
Marital Status p1f5q44
Data ElementVariables
Facility Type p1f1q15
p1f1q16
p1f1q17
Provider Type p1f1q18
p1f1q19
p1f1q20
p1f1q21
p1f1q22
p1f1q23
p1f1q24
p1f1q25
p1f1q26
p1f1q27
p1f5q5
p1f5q5r
Quality of Care
Visit p1f1q04a_1
p1f1q04a_2
p1f4q04a_1a
Data ElementVariables
Country of Care
Facility Type
Quality of Care p1f5q32
p1f5q33
p1f5q33a
p2f1q39
p2f1q40
p2f1q40a
Data ElementVariables
Final Diagnosis
Hospitalization p1f1q17_2
ICU
Data ElementVariables
Echocardiogram p1f9label1
p1f9label2
p1f9label3c
p1f9label8_2
p1f9label8_3
p1f9label8_4
p1f9label8_5
p1f9label9_2
p1f9label9_2b
p1f9label9_3
p1f9q00b
p1f9q01
p1f9q02
p1f9q03
p1f9q03_a
p1f9q03_b
p1f9q04
p1f9q04_a
p1f9q05
p1f9q05_a
p1f9q06
p1f9q06_a
p1f9q06_a_na
p1f9q06_b
p1f9q06_b_na
p1f9q07
p1f9q07_a
p1f9q07_b
p1f9q08
p1f9q08_a
p1f9q08_b1
p1f9q08_b1b
p1f9q08_b2
p1f9q08_b3
p1f9q08_b3b
p1f9q08_b4
p1f9q08_b4b
p1f9q09
p1f9q09_a
p1f9q09_b1
p1f9q09_b2
p1f9q09_b3
p1f9q10
p1f9q10_a
Data ElementVariables
Electrocardiogram (ECG) p1f9q11
p1f9q11_a
p1f9q11_b
p1f9q12_a
p1f9q12_b
p1f9q13_a
p1f9q13_b
p1f9q14_a
p1f9q14_b
p1f9q15_a
p1f9q15_b
p1f9q16_a
p1f9q16_b
Data ElementVariables
Cognitive Functioning p2f1q34a
p2f1q34b
p2f1q34c
p2f1q34d
Emotional Functioning
Physical Functioning
School Functioning
Social Functioning
Data ElementVariables
SCD Impact
SCD Management p2f1q37
p2f1q38a
p2f1q38b
p2f1q38c
p2f1q38d
Data ElementVariables
Blood Differential Test p1f2q10
p1f2q11
p1f2q12
p1f2q13
Blood Gases p1f1q11
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count p1f2q1
p1f2q2
p1f2q4
p1f2q5
p1f2q6
p1f2q7
p1f2q8
p1f2q9
Comprehensive Metabolic Panel (CMP) p1f2q1_1b
p1f2q14
p1f2q15
p1f2q16
p1f2q17
p1f2q18
p1f2q19
p1f2q20
p1f2q21
p1f2q22
p1f2q23
p1f2q24
p1f2q25
p1f2q26
p1f2q26_1a
p1f2q27
p1f2q28
p1f2q29
p1f2q3
p1f2q30
p1f2q31
p1f2q32
p1f2q33
p1f2q35
p1f2q36
p1f2q41
p1f2q42
p1f8label5
p1f8q03a
p1f8q03b
Enzyme p1f2q34
General
Hemoglobin Electrophoresis p1f1q05
p1f2q50
p1f2q50_1
p1f2q50_10
p1f2q50_2
p1f2q50_3
p1f2q50_4
p1f2q50_5
p1f2q50_6
p1f2q50_7
p1f2q50_8
p1f2q50_9
p1f2q51
p1f2q51_1
p1f2q51_10
p1f2q51_2
p1f2q51_3
p1f2q51_4
p1f2q51_5
p1f2q51_6
p1f2q51_7
p1f2q51_8
p1f2q51_9
p1f2q52
p1f2q52_1
p1f2q52_10
p1f2q52_2
p1f2q52_3
p1f2q52_4
p1f2q52_5
p1f2q52_6
p1f2q52_7
p1f2q52_8
p1f2q52_9
Iron p1f2q37
p1f2q38
p1f2q39
p1f2q39_1a
p1f2q40
Data ElementVariables
Cardiovascular Test p1f9q17_1
p1f9q17_a
p1f9q17_b
p1f9q18_a
p1f9q18_b
p1f9q19_a
p1f9q19_b
p1f9q20_a
p1f9q20_b
p1f9q21_a
p1f9q21_b
p1f9q22_a
p1f9q22_b
p1f9q23_a
p1f9q23_b
Data ElementVariables
Genitourinary Test
Urine Test p1f2q43
p1f2q43_1
p1f2q43_1a
p1f2q44
p1f2q44_1
p1f2q45
p1f2q45_1
p1f2q46
p1f2q46_1
p1f2q47
p1f2q47_1
p1f2q48
p1f2q48_1r
p1f2q48_1r_2
p1f2q48_unit
p1f2q49
p1f2q49_1r
p1f2q49_1r_2
p1f2q49_unit
Data ElementVariables
Abdomen
Anthropometrics p1f1q06
p1f1q07
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs p1f1q08
p1f1q09
p1f1q10
p1f1q12
p1f1q12_1
p1f1q12_2
p1f1q12_3
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular p2f1q29
p2f1q29a
Compliance
Current Medication
Depression Medication History
Hydroxyurea p1f1q13
p1f1q13a
p1f1q13b
p1f1q13c
p1f1q13c1
p1f1q13d
p1f1q13d_2
p1f5q15
p1f5q16
p1f5q16a
p1f5q17
p1f5q18
p1f5q19
p1f5q19a
p1f5q20
p1f5q21
p1f5q22
p1f5q22a
p2f1q17
p2f1q18
p2f1q19
p2f1q19a
p2f1q20
p2f1q21
p2f1q22
p2f1q22a
Medication p1f1q14
p1f5q31_1
p2f1q28
p2f1q30
p2f1q30a
Neurologic Medication History
Pain p1f5q6
p2f1q01
p2f1q02
p2f1q02a
p2f1q02b
SCD Medication p2f1q14
p2f1q23
p2f1q24
p2f1q25
p2f1q25a
p2f1q26
p2f1q27
p2f1q27a
p2f1q31
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion p1f1q28
p1f1q28_1
p1f1q28_2
p1f1q28_3
p1f1q28_4
p1f1q28_5
p1f1q30
p1f1q30_1
p1f1q30_2
p1f1q30_3
p1f1q30_4
p1f1q30_5
p1f5q23
p1f5q24
p1f5q25
p1f5q26
p1f5q27
p2f1q12
p2f1q13
Chronic Transfusion p1f1q29
p1f1q29_1
p1f1q29_2
p1f1q29_3
p1f1q29_4
p1f1q29_5
p1f1q29_6
p1f1q31
p1f1q31_1
p1f1q31_2
p1f1q31_3
p1f1q31_4
p1f1q31_5
p1f1q31_6
Transfusion Complications
Data ElementVariables
ASCQ-Me Emotional Impact p1f5q37e
p1f5q37f
p2f1q33e
p2f1q33f
ASCQ-Me Social Functioning p1f5q39
p1f5q39a
p1f5q39b
p2f1q36a
p2f1q36b
NeuroQOL Fatigue p1f5q37g
p2f1q33g
Pearlin Enhanced Self-Efficacy Scale
Profile of Mood States (POMS)
PROMIS Emotional Distress- Depression p1f5q37a
p1f5q37b
p1f5q37c
p1f5q37d
p2f1q33a
p2f1q33b
p2f1q33c
p2f1q33d
Data ElementVariables
Achenbach Child Behavior Checklist (CBCL)
Bayley Scale of Infant and Toddler Development
Behavior Rating Inventory of Executive Function (BRIEF)
California Verbal Learning Test
Children's Memory Scale
Connor's Continuous Performance Test II
NeuroQOL Cognitive Function p1f5q35a
p1f5q35b
p1f5q35c
p1f5q35d
p1f5q36a
p1f5q36b
p1f5q36c
p1f5q36d
p2f1q34a
p2f1q34b
p2f1q34c
p2f1q34d
p2f1q35a
p2f1q35b
p2f1q35c
p2f1q35d
Peabody Picture Vocabulary Test (PPVT)
Data ElementVariables
Adaptive Behavior Assessment System-II
Adverse Childhood Experience Questionnaire (ACE-Q) p2f2q01
p2f2q01a
p2f2q02
p2f2q02a
Beery Developmental Test of Visual-Motor Integration
Benton Tactile Form Perception Test
Oral Verbal Fluency Test
Purdue Pegboard (SPA version)
Vineland Adaptive Behavior Summary
Wechsler Intelligence Scales
Woodcock-Johnson Revised, Tests of Achievement
Woodcock-Johnson, Revised, Tests of Cognitive Ability
Data ElementVariables
ASCQ-Me Pain Episode fp1f5q06
p1f5q10
p1f5q11
p1f5q7
p1f5q8
p1f5q9
p2f1q03
p2f1q04
p2f1q05
p2f1q07
ASCQ-Me Pain Impact p1f5q12a
p1f5q12b
p1f5q13a
p1f5q13b
p2f1q08a
p2f1q08b
p2f1q09a
p2f1q09b
Brief Pain Inventory (BPI)
PROMIS Neuropathic Pain Quality p1f5q14a
p2f1q10a
PROMIS Nociceptive Pain Quality p1f5q14b
p2f1q10b
PROMIS Pain Interference
Data ElementVariables
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory Child Report (ages 13-18)
Pediatric Quality of Life Inventory Child Report (ages 8-12)
Pediatric Quality of Life Inventory Parent Report for Child (ages 13-18)
Pediatric Quality of Life Inventory Parent Report for Child (ages 8-12)
PROMIS Self-Efficacy for Managing Medications and Treatment p2f1q38a
p2f1q38b
p2f1q38c
p2f1q38d
SF-36 Health Survey
Data ElementVariables
ASCQ-Me Sleep Impact p1f5q34a
p1f5q34b
p2f1q32a
p2f1q32b
Back to Study List