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Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization

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ClinicalTrials.gov Identifier: NCT04080167
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
University of Memphis
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

This project proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea (HU). Using a stepped-wedge design, The investigators will test two innovative interventions utilizing mobile health 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 clinical knowledge barriers in prescribing and monitoring hydroxyurea use. These two interventions will be tested through the following aims:

Aim 1. Improve Patient Adherence to Hydroxyurea: Addressing Memory, Motivation, and Knowledge Barriers to Hydroxyurea Use. Primary hypothesis: The investigators hypothesize that among adolescents and adults with SCD, the adherence to hydroxyurea, as measured by proportion of daily coverage (PDC), will increase by at least 20% at 24 weeks after receiving the InCharge Health app, compared to their hydroxyurea adherence at baseline.

Sub-aim 1.a. To examine and assess both patient engagement and behaviors related to use of the InCharge Health app, the investigators will evaluate consistent use of the app among enrolled patients, patient satisfaction, and continued use of the app beyond the study period.

Sub-Aim 1.b. To examine the clinical influence of the use of the InCharge Health app on PDC, patients' clinical outcomes, perceived health literacy, health related quality of life, and perceived self-efficacy between baseline and 24 weeks.

Aim 2. Improve Provider Hydroxyurea Awareness, Prescribing and Monitoring Behaviors.

Sub-Aim 2.a. To examine and assess provider engagement and behaviors related to use of the SCD HU Toolbox, the investigators will evaluate consistent use of the app among enrolled providers, providers' satisfaction, and continued use of the app beyond the study period.

Sub-Aim 2.b. To assess the combined effects of the patient and provider mHealth interventions on hydroxyurea and health care utilization, the investigators will examine if the changes in hydroxyurea adherence are enhanced by the use of both provider and patient interventions compared to those not exposed to one or both interventions.

Aim 3. Identify and Evaluate the Barriers and Facilitators to the use of mHealth Interventions.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: InCharge Health mobile application Behavioral: HU Toolbox mobile application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 368 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: nonrandomized, closed cohort, stepped-wedge cluster trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization- mESH Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arm Intervention/treatment
Arm 1 (InCharge Health app)
Patient receives the InCharge Health app for 6 months
Behavioral: InCharge Health mobile application
The InCharge Health app features include: Daily reminders; Ability to customize content of message and time of day when the message comes; Symptom tracker to monitor daily pain and mood; 7-day streak that tracks daily adherence; Graphing adherence against pain symptoms; Communication feature allowing the patient to connect to the clinic and a "health partner"; Link to discussion forum where communication to other patients can occur; Education bank that provides information about SCD and hydroxyurea. Participants can delay daily push notifications. If hospitalized, participants may stop notifications. A special feature of the app is to set up a "health partner", who may be a person the participant may choose from his/her contact list and who will receive notifications if it had been <4 hours since not documenting the use of hydroxyurea. The "app healthy partner" will be encouraged to message the participant to remind him/her to take the medication.

Arm 2 (HU Toolbox app)
Provider receives the HU Toolbox app for 9 months
Behavioral: HU Toolbox mobile application
The HU Toolbox app includes algorithms for hydroxyurea use and is ready for immediate use on Apple and Android operating systems. In addition, it has the NHLBI guidelines adapted for pediatrics (guidelines/recommendations separated by age) and for adults (guidelines/ recommendations separated by organ system, laboratory, or physical exam finding). The HU Toolbox app includes the ability to search guidelines for key words and add notes. Algorithms are also included as PDF documents that can be printed out or emailed. Finally, a contact list of local SCD specialists and important contacts is included, so providers can easily contact SCD experts and expect an answer in 24 hours or less. The HU Toolbox app is easily updated with all data and resources stored on a cloud-based server that can provide instant up-to-date information to those using the app.




Primary Outcome Measures :
  1. Measure of the association between InCharge Health app to patient hydroxyurea adherence [ Time Frame: baseline (prior to the intervention), week 12, week 24 ]
    The primary outcome is the change in proportion of days covered (PDC) of hydroxyurea from baseline (prior the intervention) to week 24. PDC is calculated as the number of days covered (i.e., days of prescription refill dates and supply of each prescription) divided by the number of days in a treatment time point then multiple by 100 to obtain the PDC as a percentage.


Secondary Outcome Measures :
  1. Implementation of InCharge Health app. [ Time Frame: baseline, 24 weeks, 36 weeks ]
    Proportion and representativeness of patients participating/enrolled in the study (numerator) among all patients who receive hydroxyurea treatment and were eligible (denominator) at each site.

  2. Change in mean corpuscular volume (MCV) [ Time Frame: baseline, 24 weeks ]
    Mean MCV

  3. Change in fetal hemoglobin [ Time Frame: baseline, 24 weeks ]
    Mean fetal hemoglobin

  4. Change in mean hemoglobin concentration [ Time Frame: baseline, 24 weeks ]
    Mean hemoglobin

  5. Change in absolute reticulocyte count [ Time Frame: baseline, 24 weeks ]
    Mean absolute reticulocyte count

  6. Change in absolute neutrophil count (ANC) [ Time Frame: baseline, 24 weeks ]
    Mean ANC

  7. Change in bilirubin (indirect) [ Time Frame: baseline, 24 weeks ]
    Mean indirect bilirubin

  8. Change in mean plasma lactate dehydrogenase (LDH) [ Time Frame: baseline, 24 weeks ]
    Mean LDH

  9. Change in rate of emergency room visits per patient per year [ Time Frame: baseline, 24 weeks ]
    Frequency of emergency room visits per patient.

  10. Change in rate of hospitalization per patient per year [ Time Frame: baseline, 24 weeks ]
    Frequency of hospitalizations per patient.

  11. Change in patient reported pain quality [ Time Frame: baseline, 24 weeks ]
    Patient reported outcomes information system (PROMIS) pain quality scale (never, rarely, sometimes, often, always)

  12. Change in patient reported pain impact: ASCQ-Me Pain Impact scale [ Time Frame: baseline, 24 weeks ]
    The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity Scale (never, rarely, sometimes, often, always)

  13. Change in patient reported pain frequency and severity [ Time Frame: baseline, 24 weeks ]
    The Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity scale (never, rarely, sometimes, often, always)

  14. Change in healthy literacy [ Time Frame: baseline, 24 weeks ]
    Single item literacy screener (SILS). (Never, rarely, sometimes, often, always)

  15. Change in perceived self-efficacy [ Time Frame: baseline, 24 weeks ]
    Patient reported outcomes information system (PROMIS) medication self-efficacy short form (I am not at all confident, I am a little confident, I am somewhat confident, I am quite confident, and I am very confident)

  16. Change in provider knowledge of hydroxyurea (HU) prescription guidelines [ Time Frame: baseline, 9 months ]
    Hydroxyurea knowledge scale (comfort level and effectiveness in prescribing hydroxyurea from 0 to 5)

  17. Change is provider self-efficacy of hydroxyurea (HU) prescription guidelines [ Time Frame: baseline, 9 months ]
    Hydroxyurea self-efficacy scale (comfort level and effectiveness in prescribing hydroxyurea from 0 to 5)

  18. Implementation of the HU Toolbox [ Time Frame: baseline, 36 weeks, 48 weeks ]
    Mean change in provider satisfaction and proportion of providers that use the toolbox app at least once a week based on monthly clicks.

  19. Combined effects of the patient and provider mHealth interventions [ Time Frame: baseline, 36 weeks ]
    Patients' proportion of daily coverage and hospitalizations and emergency department visits per patient.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 15 years up to and including 45 years
  • Treated at or affiliated with one of the SCDIC sites
  • English speaking
  • 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 Sβ-thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
  • Willing and cognitively able to give informed consent
  • Access to a cellular/mobile smart phone (either Android or IPhone are acceptable)
  • Hydroxyurea therapy: Already receiving hydroxyurea therapy: defined as at least one prior prescription to hydroxyurea in the past 3 months. 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 52 patients target accrual for the site. A max of 30 patients who are initiating hydroxyurea can be enrolled per site.

Exclusion Criteria:

  • Current pregnancy
  • On a chronic transfusion program in which they receive more than 8 erythrocyte transfusions in a 12-month period.
  • A red blood cell transfusion in the past 60 days
  • Currently using another phone application or an online-based tool (e-health tool) to increase hydroxyurea adherence

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): NCT04080167


Contacts
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Contact: Jane Hankins, MD 866-278-5833 referralinfo@stjude.org

Locations
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United States, California
University of California San Francisco Not yet recruiting
Oakland, California, United States, 94609
Contact: Marsha Treadwell, PhD    510-428-3168    marsha.treadwell@ucsf.edu   
Principal Investigator: Marsha Treadwell, PhD         
United States, Georgia
Georgia Regents University Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Abdulah Kutlar, MD    706-721-2171    akutlar@augusta.edu   
Principal Investigator: Abdulah Kutlar, MD         
United States, Illinois
University of Illinois Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Victor Gordeuk, MD    312-996-5680    vgordeuk@uic.edu   
Principal Investigator: Victor Gordeuk, MD         
United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: Allison King, MD, PhD, MPH    314-454-6018    king_a@wustl.edu   
Principal Investigator: Allison King, MD, PhD, MPH         
United States, New York
Icahn School of Medicine at Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Lynn Richardson, MD    212-824-8066    Lynne.Richardson@mssm.edu   
Principal Investigator: Lynn Richardson, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Nirmish Shah, MD    919-668-5178    nirmish.shah@duke.edu   
Principal Investigator: Nirmish Shah, MD         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Cathy Melvin, PhD    843-876-2426    melvinc@musc.edu   
Principal Investigator: Cathy Melvin, PhD         
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Chinonyelum Nwosu, MPH    901-595-7566    chinonyelum.nwosu@stjude.org   
Contact: Hamda Khan, MA    901-595-0294    hamda.khan@stjude.org   
Principal Investigator: Jane Hankins, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
University of Memphis
Investigators
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Principal Investigator: Jane Hankins, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT04080167     History of Changes
Other Study ID Numbers: mESH
5U01HL133996 ( U.S. NIH Grant/Contract )
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available at the time of article publication.
Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
implementation science
sickle cell anemia
digital medicine
adherence
hydroxycarbamide
health innovation
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors