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

NCT04080167 | Completed Results

• 2 other identifiers: mESH5U01HL133996
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 7

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 percentage of days covered (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 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.

Conditions

Sickle Cell Disease

Keywords

implementation science; sickle cell anemia; digital medicine; adherence; hydroxycarbamide; health innovation

Outcome Measures

Primary Outcomes (1)

• Mean Change in PDC From Baseline Through 24 Weeks

  The primary outcome is the change in the percentage of days covered (PDC) of hydroxyurea, measured by comparing PDC during the 24-week baseline interval (i.e. prior the intervention) with PDC during the 24-week follow-up interval. 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 multiply by 100 to obtain the PDC as a percentage.

  baseline (prior to the intervention), week 24

Secondary Outcomes (18)

• Implementation of InCharge Health App.

  baseline, 24 weeks

• Change in Mean Corpuscular Volume (MCV)

  baseline, 24 weeks

• Change in Fetal Hemoglobin

  baseline, 24 weeks

• Change in Hemoglobin Concentration

  baseline, 24 weeks

• Change in Reticulocyte Percentage

  baseline, 24 weeks

Study Arms (2)

Arm 1 (InCharge Health app)

OTHER

Patient receives the InCharge Health app for 6 months

Behavioral: InCharge Health mobile application

Arm 2 (HU Toolbox app)

OTHER

Provider receives the HU Toolbox app for 9 months

Behavioral: HU Toolbox mobile application

Interventions

InCharge Health mobile application BEHAVIORAL

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 1 (InCharge Health app)

HU Toolbox mobile application BEHAVIORAL

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.

Arm 2 (HU Toolbox app)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• RTI International: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Memphis: collaborator

Study Sites (7)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

• Badawy SM, DiMartino L, Brambilla D, Klesges L, Baumann A, Burns E, DeMartino T, Jacobs S, Khan H, Nwosu C, Shah N, Hankins JS; Sickle Cell Disease Implementation Consortium. Impact of the COVID-19 Pandemic on the Implementation of Mobile Health to Improve the Uptake of Hydroxyurea in Patients With Sickle Cell Disease: Mixed Methods Study. JMIR Form Res. 2022 Oct 14;6(10):e41415. doi: 10.2196/41415.

  PMID: 36240004 BACKGROUND

• Hankins JS, Brambilla D, Potter MB, Kutlar A, Gibson R, King AA, Baumann AA, Melvin C, Gordeuk VR, Hsu LL, Nwosu C, Porter JS, Alberts NM, Badawy SM, Simon J, Glassberg JA, Lottenberg R, DiMartino L, Jacobs S, Fernandez ME, Bosworth HB, Klesges LM, Shah N. A multilevel mHealth intervention boosts adherence to hydroxyurea in individuals with sickle cell disease. Blood Adv. 2023 Dec 12;7(23):7190-7201. doi: 10.1182/bloodadvances.2023010670.

  PMID: 37738155 DERIVED

• Hankins JS, Shah N, DiMartino L, Brambilla D, Fernandez ME, Gibson RW, Gordeuk VR, Lottenberg R, Kutlar A, Melvin C, Simon J, Wun T, Treadwell M, Calhoun C, Baumann A, Potter MB, Klesges L, Bosworth H; Sickle Cell Disease Implementation Consortium. Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study. JMIR Res Protoc. 2020 Jul 14;9(7):e16319. doi: 10.2196/16319.

  PMID: 32442144 DERIVED

Related Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Limitations and Caveats

Due to the onset of the Covid 1-19 pandemic and delays with the IRB at several institutions, we had to move to a staggered enrollment instead of a full stepped wedge design. The process was outlined in the paper under Citations. The Covid-19 pandemic also caused clinic lockdowns which impacted the implementation of the mHealth intervention at some sites. Sites were able to adapt recruitment and implementation measures to continue the study.

Results Point of Contact

• Title: Jane Hankins, MD
• Organization: St. Jude Children's Research Hospital

jane.hankins@stjude.org

(901) 595-4974

Study Officials

• Jane Hankins, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: nonrandomized, closed cohort, stepped-wedge cluster trial

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: September 6, 2019
• Study Start: November 11, 2019
• Primary Completion: April 6, 2022
• Study Completion: August 31, 2022
• Last Updated: November 29, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available by BIOLINCC for the study, upon request.
• Access Criteria: Access to the data must be requested through BIOLINCC by first creating an account and submitting a request for the data through the BIOLINCC website.

Locations

US (7)