Details - CureSickleCell

Study ID	1021
Name	Integrating m-Health into SCD Care to Increase Hydroxyurea Utilization
Contact Email	jane.hankins@stjude.org
Acronym	SCDIC mESH
Period	2019 - 2022
Design	Clinical Trial
Study PI	Jane Hankins
Institution	St. Jude Children's Research Hospital
URL	https://clinicaltrials.gov/ct2/show/NCT04080167
CTGovID	https://clinicaltrials.gov/ct2/show/NCT04080167
Funding Agency	NHLBI
Grant Number	5U01HL133996-02

Overview	The purpose of this project is to improve adherence to hydroxyurea therapy. Multiple approaches for improving adherence with pharmaceutical regimens have been studied and demonstrate a need to address barriers that both providers and patients face. This project aims to test two innovative interventions utilizing mobile health (mHealth), to address both patients’ and providers’ needs: 1) an mHealth application for patients (InCharge Health app) that includes multi-component features to address the memory, motivation, and knowledge barriers to hydroxyurea use, and 2) an mHealth toolbox application for providers (HU Toolbox app) that addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea use.
Focus Areas	1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge Barriers to Hydroxyurea Use. 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors. 3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth Interventions.
Outcomes	1. Measure of the association between InCharge Health app to patient hydroxyurea adherence [ Time Frame: baseline (prior to the intervention), week 12, week 24 ] 2. Implementation of InCharge Health app. [ Time Frame: baseline, 24 weeks, 36 weeks] 3. Change in mean corpuscular volume (MCV) [ Time Frame: baseline, 24 weeks] 4. Change in fetal hemoglobin [ Time Frame: baseline, 24 weeks ] 5. Change in mean hemoglobin concentration [ Time Frame: baseline, 24 weeks ]

Data Location	RTI International
Biospecimen Available	Blood; Serum;
Data Consent	De-identified data will be shared outside SCDIC; investigators must adhere to Data Use Agreement
Biospecimen Consent	Investigators must adhere to Data Use Agreement
Contact Consent	NA
Genomic Data	No

Age Range	15-45
No. Participants	293
Inclusion Criteria	1. Age 15 years up to and including 45 years 2. Treated at or affiliated with one of the SCDIC sites 3. English speaking 4. Confirmed Sickle Cell Disease (SCD) diagnosis. An SCD diagnosis is defined as Hb fractionation test (e.g., high- performance liquid chromatography or another technique) that is diagnostic of one the following: Hb SS, Hb SC, Hb Sß-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF. 5. Willing and cognitively able to give informed consent 6. Access to a cellular/mobile smart phone (either Android or IPhone are acceptable) 7. Hydroxyurea therapy: Already receiving hydroxyurea therapy: defined as at least one prior prescription to hydroxyurea in the past 3 months and no plans to escalate the dose by more than 5 mg/kg/day. Initiating hydroxyurea therapy: defined as at least one prescription written at the time of study enrollment (the first prescription must be written on the same day as study enrollment). Patients who initiate hydroxyurea on the same day of study enrollment will not contribute to the total of 46 patients target accrual for the site. A max of 30 patients who are initiating hydroxyurea can be enrolled per site.
Exclusion Criteria	1. Current pregnancy 2. On a chronic transfusion program in which they receive more than 8 erythrocyte transfusions in a 12-month period. 3. A red blood cell transfusion in the past 60 days 4. Currently using another phone application or an online-based tool (e-health tool) to increase hydroxyurea adherence

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Clinical status (3)

Behavior (0)

Blood (1)

Concept	Variables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease	s1f1q02

Cancer (0)

Cardiovascular (0)

Digestive (0)

Endocrine (0)

Family MedHx (0)

General Health (0)

Genitourinary (0)

Immune (0)

Lymphatic (0)

Medical Event (2)

Concept	Variables
Adverse event
Death	s1f3q02c s1f5q02c
Disability Status
Hospitalization
Medical Event
Serious Adverse Event

Medical History (0)

Mental Health (0)

Musculoskeletal (0)

Neurodevelopmental (0)

Neurologic (0)

Nutritional and Metabolic (0)

Ocular (0)

Oral (0)

Pain (0)

Reproductive (0)

Respiratory (0)

Skin (0)

Sleep (0)

Surgery History (0)

COVID-19 (0)

Diagnosis (0)

Impact (0)

Treatment (0)

Vaccination (0)

Demographics (18)

Demographics (5)

Concept	Variables
Address	s1f0qb05
Age	s1f0qb01
Ethnic Group	s1f0qb03
Gender	s1f0qb04
Language
National Origin
Nuclear Family
Race	s1f0qb02

Social Determinants of Health (SDoH) (0)

Socioeconomic Status (13)

Concept	Variables
Annual Income	s1f3qb05 s1f3qb08
Education	s1f3qb02
Employment Status	s1f3qb03 s1f3qb03a
Household
Insurance	s1f3qb06 s1f3qb06a s1f4qe01 s1f4qe02 s1f4qe03 s1f4qe04 s1f4qe05
Marital Status	s1f3qb01

Environmental Exposure (0)

Exposure (0)

Health Care (172)

Acute Care Utilization (11)

Concept	Variables
Facility Type	s1f1q11 s1f1q11_1a s1f1q11_1b s1f1q11_1c s1f1q12 s1f1q12_1a s1f1q12_1b s1f1q12_1c s1f4qf03 s1f4qf04 s1f4qf04_a
Provider Type
Quality of Care
Visit

Health Services (62)

Concept	Variables
Provider	s1f5qb1 s1f5qb10 s1f5qb11 s1f5qb12 s1f5qb12b s1f5qb13 s1f5qb14 s1f5qb15 s1f5qb16 s1f5qb17 s1f5qb2 s1f5qb2a s1f5qb3 s1f5qb4 s1f5qb5 s1f5qb6 s1f5qb7a s1f5qb7b s1f5qb7c s1f5qb7d s1f5qb8a_a s1f5qb8a_b s1f5qb8a_c s1f5qb8a_d s1f5qb8a_e s1f5qb8a_f s1f5qb9 s1f5qb9b s1f5qd1 s1f5qd10 s1f5qd2 s1f5qd3 s1f5qd4 s1f5qd4b s1f5qd5 s1f5qd6 s1f5qd6b s1f5qd7 s1f5qd8 s1f5qd9 s1f5qd9b
Resource Implementation	r1s1q1 r1s1q2 r1s1q3 r1s1q4 r1s1q5 r1s1q6 r1s1q7 r1s1q8 r1s1q9 r1s2q1 r1s2q2 r1s2q3 r1s2q4 r1s2q5 r1s3q1 r1s3q2 r1s3q3 r1s4q1 r1s4q2 r1s4q3 r1s4q4

Healthcare utilization (21)

Concept	Variables
Country of Care
Facility Type	s1f4qa02_a s1f4qa02_b s1f4qa02_c s1f4qa02_d s1f4qa03 s1f4qa04 s1f4qb01a s1f4qb01b s1f4qb01c s1f4qb01d s1f4qb01e s1f4qb02a s1f4qb02b s1f4qb03a s1f4qb03b s1f4qb03c s1f4qb04 s1f4qf01 s1f4qf01_a s1f4qf02 s1f4qf02_a
Quality of Care

Hospitalization (4)

Concept	Variables
Final Diagnosis
Hospitalization	s1f1q13 s1f1q13_1a s1f1q13_1b s1f1q13_1c
ICU

SCD Management (74)

Concept	Variables
Technology Support	r1s10q1 r1s10q2 r1s10q3 r1s11q1 r1s11q2 r1s12q1 r1s12q2 r1s12q3 r1s5q1 r1s5q2 r1s5q3 r1s5q4 r1s6q1 r1s6q2 r1s6q3 r1s6q4 r1s7q1 r1s7q2 r1s8q1 r1s8q2 r1s8q3 r1s9q1 r1s9q2 r1s9q3 r1s9q4 s1f3qh01 s1f3qh02 s1f3qh03_a s1f3qh03_b s1f3qh03_c s1f3qh03_d s1f3qh03_e s1f3qh03_f s1f3qh03_g s1f3qh03_h s1f3qh04a s1f3qh04b s1f3qh04c s1f3qh04d s1f3qh04e s1f3qh04f s1f3qh05 s1f3qh06 s1f3qh07 s1f3qh08 s1f3qh09 s1f5qc1 s1f5qc10 s1f5qc11 s1f5qc12 s1f5qc13 s1f5qc14 s1f5qc15 s1f5qc16 s1f5qc17 s1f5qc18 s1f5qc19 s1f5qc2 s1f5qc20 s1f5qc21 s1f5qc22 s1f5qc23 s1f5qc24 s1f5qc25 s1f5qc26 s1f5qc27 s1f5qc28 s1f5qc3 s1f5qc4 s1f5qc5 s1f5qc6 s1f5qc7 s1f5qc8 s1f5qc9

Imaging (0)

Angiogram (0)

Catheterization (0)

CT Scan (0)

Echocardiogram (0)

Electrocardiogram (ECG) (0)

Electrodiagnosis (0)

General Imaging (0)

MRI/MRA (0)

Nuclear Medicine Imaging (0)

PET scan (0)

Transcranial Doppler (TCD) (0)

Ultrasound (0)

X-Ray (0)

Parent/Caretaker (0)

Demographics (0)

Psychosocial (0)

Quality of Life (0)

Quality of Life (20)

Functional Status (9)

Concept	Variables
Behavior
Cognitive
Mental Health
Physical
SCD Management	s1f3qda s1f3qdb s1f3qdc s1f3qdd s1f3qde s1f3qdf s1f3qdg s1f3qdh s1f3qea
Sleep/Fatigue
Social

General Health (0)

Pain (11)

Concept	Variables
General Pain	s1f3qc06a s1f3qc06b s1f3qc07a s1f3qc07b s1f3qc08a s1f3qc08b
Pain Attack	s1f3qc01 s1f3qc02 s1f3qc03 s1f3qc04 s1f3qc05
Skeletal and Joint Pain

Tests (83)

Biopsy (0)

Blood (61)

Concept	Variables
Blood Differential Test	s1f2q06 s1f2q06a s1f2q06b
Blood Gases
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count	s1f2q01 s1f2q01a s1f2q02 s1f2q02a s1f2q03 s1f2q03a s1f2q04 s1f2q04a s1f2q05 s1f2q05a s1f2q07 s1f2q07a s1f2q07b s1f2q14 s1f2q14a_1 s1f2q14a_2 s1f2q14a_3 s1f2q14a_4 s1f2q14a_5 s1f2q14a_6 s1f2q14a_7 s1f2q14a_8 s1f2q14a_9 s1f2q14a_9_sp
Comprehensive Metabolic Panel (CMP)	s1f2q08 s1f2q08a s1f2q09 s1f2q09a s1f2q10 s1f2q10a s1f2q11 s1f2q11a s1f2q12 s1f2q12a
Enzyme	s1f2q13 s1f2q13a
General
Hemoglobin Typing	s1f2q15 s1f2q15a_1 s1f2q15a_2 s1f2q15a_3 s1f2q15a_4 s1f2q15a_5 s1f2q15a_6 s1f2q15a_7 s1f2q15a_8 s1f2q15a_9 s1f2q15a_9_sp s1f2q16 s1f2q16a_1 s1f2q16a_2 s1f2q16a_3 s1f2q16a_4 s1f2q16a_5 s1f2q16a_6 s1f2q16a_7 s1f2q16a_8 s1f2q16a_9 s1f2q16a_9_sp
Iron

Cardiovascular (0)

Genitourinary (0)

Immune (0)

Microbiology Culture (0)

Musculoskeletal (0)

Neurologic (0)

Ocular (0)

Other (0)

Physical Exam (22)

Concept	Variables
Abdomen
Anthropometrics	s1f1q03 s1f1q03_1 s1f1q03_3 s1f1q04 s1f1q04_1 s1f1q04_3
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs	s1f1q05 s1f1q05_1 s1f1q05_3 s1f1q06 s1f1q06_1 s1f1q06_3 s1f1q07 s1f1q07_1 s1f1q07_3 s1f1q08 s1f1q08_1 s1f1q08_3 s1f1q09 s1f1q09_1 s1f1q09_2 s1f1q09_5

Reproductive (0)

Respiratory (0)

Therapeutics (73)

Medication (47)

Concept	Variables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication	s1f1q09_3 s1f1q14 s1f1q14_1
Depression Medication History
Hydroxyurea	refill s1f1q10a s1f1q10b s1f1q10c_1 s1f1q10c_2 s1f1q10c_u s1f1q10d s1f1q10d_rsn s1f1q20a s1f1q20b s1f3qf01 s1f3qf02 s1f3qf03 s1f3qf04 s1f3qf04a s1f3qg01 s1f3qg02 s1f3qg03 s1f3qg04 s1f3qg05
Medication
Neurologic Medication History
Pain
SCD Medication	s1f1q11b s1f1q11b_a s1f1q11b_b s1f1q11b_b1 s1f1q11b_c s1f1q11b_c1 s1f1q11b_d s1f1q11b_e s1f1q12b s1f1q12b_a s1f1q12b_b s1f1q12b_b1 s1f1q12b_c s1f1q12b_c1 s1f1q12b_d s1f1q12b_e s1f1q13b s1f1q13b_a s1f1q13b_b s1f1q13b_b1 s1f1q13b_c s1f1q13b_c1 s1f1q13b_d s1f1q13b_e
Sildenafil
Supplements

Surgery (0)

Transfusion (26)

Concept	Variables
Blood Transfusion	s1f1q15a s1f1q15a_1 s1f1q15a_2 s1f1q15a_3 s1f1q15a_4 s1f1q15a_5 s1f1q15c s1f1q15c_1 s1f1q15c_2 s1f1q15c_3 s1f1q15c_4 s1f1q15c_5
Chronic Transfusion	s1f1q15b s1f1q15b_1 s1f1q15b_2 s1f1q15b_3 s1f1q15b_4 s1f1q15b_5 s1f1q15b_6 s1f1q15d s1f1q15d_1 s1f1q15d_2 s1f1q15d_3 s1f1q15d_4 s1f1q15d_5 s1f1q15d_6
Transfusion Complications

Transplantation (0)

Treatment (0)

Study Publications

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Mental Health (0)

Neurodevelopment (0)

Neuropsychological (0)

Pain (11)

Concept	Variables
ASCQ-Me Pain Episode	s1f3qc01 s1f3qc02 s1f3qc03 s1f3qc04 s1f3qc05
ASCQ-Me Pain Impact	s1f3qc06a s1f3qc06b s1f3qc08a s1f3qc08b
ASCQ-Me Stiffness Impact
Brief Pain Inventory (BPI)
Chronic Pain
PROMIS Neuropathic Pain Quality	s1f3qc07a s1f3qc07b
PROMIS Nociceptive Pain Quality
PROMIS Pain Behavior
PROMIS Pain Interference

Physical Function (0)

Psychosocial (0)

Quality of Care (0)

Quality of Life (8)

Concept	Variables
ASCQ-Me SCD Medical History Checklist
ASCQ-Me Sexual Health
Child Health Questionnaire (CHQ)
Ladder of Life
Pediatric Quality of Life Inventory (PedsQL) (ages 1-12ms)
Pediatric Quality of Life Inventory (PedsQL) (ages 13-24ms)
Pediatric Quality of Life Inventory (PedsQL) (ages 2-4ys)
Pediatric Quality of Life Inventory (PedsQL) (ages 5-7)
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 Global Health
PROMIS Global Physical Health
PROMIS Self-Efficacy for Managing Medications and Treatment	s1f3qda s1f3qdb s1f3qdc s1f3qdd s1f3qde s1f3qdf s1f3qdg s1f3qdh
SF-36 Health Survey

Sleep (0)

Technology Support (3)

Concept	Variables
Mobile App Rating Scale	s1f3qh01 s1f3qh02 s1f3qh05

Study Documentation Select All	mESH_Protocol_Ver_1.2_07.14.20_clean
Forms Select All	1. Clinic Level Data_Baseline-Week48_Final_V1.0_17Jan2020 2. Contextual Measures_V1.0_30Mar2020 3. Patient Data Collection Form_12 Weeks_V1.0_03Feb2020 4. Patient Data Collection Form_24 Weeks_V1.0_03Feb2020 5. Patient Data Collection Form_Baseline_V1.0_03Feb2020 6. Patient_Lab Reporting_12-36Weeks_V1.0_03Feb2020 7. Patient_Lab Reporting_Baseline_V1.0_03Feb2020 8. Patient_Medical_Record_Abstraction_12-36Weeks_V1.2_01Jul2020 9. Patient_Medical_Record_Abstraction_Baseline_V1.2_01Jul2020 10. Patient_Registration_V1.0_03Feb2020 11. Provider Data Collection Form_36Weeks_V1.0_17Jan2020 12. Provider Data Collection Form_Baseline_V1.0_17Jan2020 13. Provider_Registration_V1.0_17Jan2020 14. SCDICCareRedesignContextualMea 15. SCDICCareRedesignPatient 16. SCDICCareRedesignProvider 17. SCDICCareRedesignClinic

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