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Study Detail

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://scdic.rti.org/ABOUT/Study-Protocols
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
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease s1f1q02
Data ElementVariables
Adverse event
Death s1f3q02c
s1f5q02c
Disability Status
Hospitalization
Medical Event
Serious Adverse Event
Data ElementVariables
Abdominal Pain
General Pain s1f3qc06a
s1f3qc06b
s1f3qc07a
s1f3qc07b
s1f3qc08a
s1f3qc08b
Headache
Management
Pain Attack s1f3qc01
s1f3qc02
s1f3qc03
s1f3qc04
s1f3qc05
Skeletal and Joint Pain
Data ElementVariables
Address s1f0qb05
Age s1f0qb01
Ethnic Group s1f0qb03
Gender s1f0qb04
Language
National Origin
Nuclear Family
Race s1f0qb02
Data ElementVariables
Annual Income s1f3qb05
s1f3qb08
Education s1f3qb02
Employment Status s1f3qb03
s1f3qb03a
Household
Insurance s1f3qb06
s1f3qb06a
s1f4qe01
s1f4qe02
s1f4qe03
s1f4qe04
s1f4qe05
Marital Status s1f3qb01
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
Final Diagnosis
Hospitalization s1f1q13
s1f1q13_1a
s1f1q13_1b
s1f1q13_1c
ICU
Data ElementVariables
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
Data ElementVariables
SCD Impact
SCD Management s1f3qda
s1f3qdb
s1f3qdc
s1f3qdd
s1f3qde
s1f3qdf
s1f3qdg
s1f3qdh
s1f3qea
Data ElementVariables
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
Comprehensive Metabolic Panel (CMP) s1f2q08
s1f2q08a
s1f2q09
s1f2q09a
s1f2q10
s1f2q10a
s1f2q11
s1f2q11a
s1f2q12
s1f2q12a
Enzyme s1f2q13
s1f2q13a
General
Hemoglobin Electrophoresis s1f2q14
s1f2q14a_1
s1f2q14a_2
s1f2q14a_3
s1f2q14a_4
s1f2q14a_5
s1f2q14a_6
s1f2q14a_7
s1f2q14a_8
s1f2q14a_9
s1f2q14a_9_sp
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
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
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
Data ElementVariables
ASCQ-Me Pain Episode s1f3qc01
s1f3qc02
s1f3qc03
s1f3qc04
s1f3qc05
ASCQ-Me Pain Impact s1f3qc06a
s1f3qc06b
s1f3qc08a
s1f3qc08b
Brief Pain Inventory (BPI)
PROMIS Neuropathic Pain Quality s1f3qc07a
s1f3qc07b
PROMIS Nociceptive Pain Quality
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 s1f3qda
s1f3qdb
s1f3qdc
s1f3qdd
s1f3qde
s1f3qdf
s1f3qdg
s1f3qdh
SF-36 Health Survey
Data ElementVariables
Mobile App Rating Scale s1f3qh01
s1f3qh02
s1f3qh05
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