Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04080167|
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : August 19, 2020
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 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||368 participants|
|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|
|Actual Study Start Date :||November 11, 2019|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||June 2022|
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.
- 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.
- 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.
- Change in mean corpuscular volume (MCV) [ Time Frame: baseline, 24 weeks ]Mean MCV
- Change in fetal hemoglobin [ Time Frame: baseline, 24 weeks ]Mean fetal hemoglobin
- Change in mean hemoglobin concentration [ Time Frame: baseline, 24 weeks ]Mean hemoglobin
- Change in absolute reticulocyte count [ Time Frame: baseline, 24 weeks ]Mean absolute reticulocyte count
- Change in absolute neutrophil count (ANC) [ Time Frame: baseline, 24 weeks ]Mean ANC
- Change in bilirubin (indirect) [ Time Frame: baseline, 24 weeks ]Mean indirect bilirubin
- Change in mean plasma lactate dehydrogenase (LDH) [ Time Frame: baseline, 24 weeks ]Mean LDH
- Change in rate of emergency room visits per patient per year [ Time Frame: baseline, 24 weeks ]Frequency of emergency room visits per patient.
- Change in rate of hospitalization per patient per year [ Time Frame: baseline, 24 weeks ]Frequency of hospitalizations per patient.
- 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)
- 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)
- 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)
- Change in healthy literacy [ Time Frame: baseline, 24 weeks ]Single item literacy screener (SILS). (Never, rarely, sometimes, often, always)
- 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)
- 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)
- 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)
- 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.
- 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.
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
|Contact: Jane Hankins, MDemail@example.com|
|United States, California|
|University of California San Francisco||Not yet recruiting|
|Oakland, California, United States, 94609|
|Contact: Marsha Treadwell, PhD 510-428-3168 firstname.lastname@example.org|
|Principal Investigator: Marsha Treadwell, PhD|
|United States, Georgia|
|Georgia Regents University||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Abdulah Kutlar, MD 706-721-2171 email@example.com|
|Principal Investigator: Abdulah Kutlar, MD|
|United States, Illinois|
|University of Illinois||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Victor Gordeuk, MD 312-996-5680 firstname.lastname@example.org|
|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 email@example.com|
|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|
|Durham, North Carolina, United States, 27710|
|Contact: Nirmish Shah, MD 919-668-5178 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Hamda Khan, MA 901-595-0294 email@example.com|
|Principal Investigator: Jane Hankins, MD|
|Principal Investigator:||Jane Hankins, MD||St. Jude Children's Research Hospital|