Sickle Cell DiseaseNCT04080167
Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
A study testing InCharge Health mobile application and HU Toolbox mobile application in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 7 sites in United States.
Trial 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'… Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- InCharge Health mobile application and HU Toolbox mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Nov 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Georgia Regents University
Augusta, Georgia, 30912
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27710
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Washington University
St Louis, Missouri, 63110
About this study
Official title: Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization- mESH Study
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.
Read more
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.
Read the detailed description
The National Heart, Lung, and Blood Institute (NHLBI) created the Sickle Cell Disease Implementation Consortium (SCDIC) to apply implementation science methods to identify and address barriers to guideline-based care in sickle cell disease (SCD) and promote evidence-based treatment for SCD patients between ages 15 to 45 years. The SCDIC conducted a systematic literature review and a comprehensive needs assessment among the eight participating centers. A major conclusion was that care redesign to support better hydroxyurea utilization would likely improve clinical outcomes for patients with SCD. Hydroxyurea therapy has been shown to improve patient outcomes and reduce disease complications and is endorsed by the NHLBI. SCDIC now proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea.
The overall purpose of this proposed project is to address barriers identified by the needs assessment to improve adherence with 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, via a stepped-wedge design, 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. 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. The investigators will examine among providers using the HU Toolbox App if there is an increase in reported awareness of hydroxyurea benefits and risks, accurate prescribing of hydroxyurea, and perceived self-efficacy to correctly administer hydroxyurea therapy between baseline and after 9 months of using the HU Toolbox app.
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. The investigators will evaluate the strategies used by participating sites in supporting the implementation of mHealth interventions via a mixed-method evaluation of the facilitators and barriers in adopting and implementing the mHealth interventions from multiple stakeholder perspectives: patient, provider, and organization.
Both mHealth interventions will be tested concurrently and because the investigators are using a stepped-wedge design, each site will enter the study at different times. Provider participants will receive the HU Toolbox intervention for 9 months with a lagged but overlapping introduction of the InCharge Health intervention patient participants for 24 weeks. The implementation evaluation will be guided by RE-AIM to assess the Reach, Effectiveness, Adoption, Implementation and Maintenance of the interventions. All sites will also complete follow-on needs assessment and medical record abstractions that will provide data to evaluate other patient and provider outcomes, barriers and enablers to hydroxyurea prescribing, use, and monitoring.
mHealth technology can be leveraged to support more effective use of hydroxyurea and eventually improved SCD clinical outcomes. If the mHealth applications tested in this study show preliminary efficacy, both apps could be scaled up within SCDIC centers and expanded to other institutions outside the SCDIC.
- Conditions
- Sickle Cell Disease
- Being tested
- InCharge Health mobile application, HU Toolbox mobile application
- Keywords
- implementation science, sickle cell anemia, digital medicine, adherence, hydroxycarbamide, health innovation
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InCharge Health mobile applicationBehavioural
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.
HU Toolbox mobile applicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (InCharge Health app) | Other | Patient receives the InCharge Health app for 6 months Receives: Behavioral: InCharge Health mobile application |
| Arm 2 (HU Toolbox app) | Other | Provider receives the HU Toolbox app for 9 months Receives: Behavioral: HU Toolbox mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (prior to the intervention), week 24
Secondary outcomes (18)
Implementation of InCharge Health App.
Count of all enrolled patients who used the InCharge Health app at least once during the study period among all enrolled
Measured: baseline, 24 weeks
Change in Mean Corpuscular Volume (MCV)
Mean difference between MCV during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Fetal Hemoglobin
Mean difference between fetal hemoglobin during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Hemoglobin Concentration
Mean difference between hemoglobin during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Reticulocyte Percentage
Mean difference between reticulocyte percentage during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Absolute Neutrophil Percentage
Mean difference between neutrophil percentage during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change Bilirubin
Mean difference between total bilirubin during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Mean Plasma Lactate Dehydrogenase (LDH)
Mean difference between LDH during the baseline interval and during the follow-up interval
Measured: baseline, 24 weeks
Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks
Mean difference between number of emergency room visits during the baseline interval and during the follow-up interval.
Measured: baseline, 24 weeks
Change in Rate of Hospitalization Per Patient in the Last 24 Weeks
Mean difference between number of hospitalizations during the baseline interval and during the follow-up interval.
Measured: baseline, 24 weeks
Change in Patient Reported Pain Quality
Mean difference between scores on the Patient Reported Outcomes Information System (PROMIS) Pain Quality Scale during baseline and follow-up when the responses, never, rarely, sometimes, often, and always are coded 0 through 4. The Patient Reported Outcomes Information System (PROMIS) Pain Quality Scale has a minimum value of "never", coded as 0, and a maximum value of "always", coded as 4 for analysis. A higher score indicates worse pain.
Measured: baseline, 24 weeks
Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale
Mean difference between scores on the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity Scale during baseline and follow-up when the responses, never, rarely, sometimes, often, and always are coded 0 through 4. Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity Scale has a minimum value of "never", coded as 0, and a maximum value of "always", coded as 4 for analysis. A higher score indicates worse pain.
Measured: baseline, 24 weeks
Change in Patient Reported Pain Frequency and Severity
Mean difference between scores on the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity scale during baseline and follow-up when the responses, never, rarely, sometimes, often, and always are coded 0 through 4. Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Pain Episode Frequency and Severity Scale has a minimum value of "never", coded as 0, and a maximum value of "always", coded as 4 for analysis. A higher score indicates worse pain.
Measured: baseline, 24 weeks
Change in Healthy Literacy
Mean difference between responses to the Single item literacy screener (SILS) during baseline and follow-up when the responses, Never, rarely, sometimes, often, and always are coded 0 through 4; score is the sum of responses to 8 questions (score range: 0-32). The Single item literacy screener (SILS) has a minimum value of "never", coded as 0, and a maximum value of "always", coded as 4 for analysis. A higher score means lower health literacy.
Measured: baseline, 24 weeks
Change in Perceived Self-efficacy
Mean difference between responses to the Patient reported outcomes information system (PROMIS) medication self-efficacy short form during baseline and follow-up when the responses, I am not at all confident, I am a little confident, I am somewhat confident, I am quite confident, and I am very confident are coded 0 to 4. The Patient Reported Outcomes Information System (PROMIS) Pain Quality Scale has a minimum value of "I am not at all confident", coded as 0, and a maximum value of "I am very confident", coded as 4 for analysis. A higher score indicates greater self-efficacy.
Measured: baseline, 24 weeks
Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines
Mean difference between responses during baseline and follow-up to the 5 questions on the Hydroxyurea Knowledge Scale regarding knowledge of correctly prescribing hydroxyurea. Each question was scored 0 (incorrect response) or 1 (correct) and the 5 scores were summed to produce totals of 0 to 5.
Measured: baseline, 9 months
Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines
Hydroxyurea self-efficacy scale (comfort level and perceived effectiveness in prescribing hydroxyurea) with responses scored 0 to 4. The Hydroxyurea self-efficacy scale has a minimum value of "very uncomfortable", coded as 0 and a maximum value of "very comfortable", coded as 4. A higher score indicates greater self-efficacy.
Measured: baseline, 9 months
Mean Change in PDC From Baseline Through 36 Weeks
This 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 36-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.
Measured: baseline (prior to the intervention), week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start11 Nov 2019
- Primary completion6 Apr 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- nonrandomized, closed cohort, stepped-wedge cluster trial
- Masking
- None (open label)
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International, National Heart, Lung, and Blood Institute (NHLBI), University of Memphis
- Responsible party
- Sponsor
- Investigators
- Jane Hankins, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080167
- Sponsor's protocol ID
- mESH
- Other IDs
- 5U01HL133996
- Status last verified
- Nov 2023
- First submitted
- 15 Aug 2019
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient-level data will be available to researchers outside the SCDIC through an application and approval process through BIOLINCC. To protect the confidentiality and privacy of the participants, investigators granted access to the limited access data must adhere to strict requirements incorporated into a standard Data Use Agreement. In accordance with NHLBI policy, outside researchers may also be required to submit an approval to BIOLINCC from their IRB.
Publications
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.
PubMed 36240004Hankins 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.
PubMed 37738155Hankins 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.
PubMed 32442144
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization- mESH Study
- ClinicalTrials.gov ID
- NCT04080167
- Acronym / sponsor ID
- mESH
- Conditions
- Sickle Cell Disease
- Keywords
- implementation science, sickle cell anemia, digital medicine, adherence, hydroxycarbamide, health innovation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- RTI International, National Heart, Lung, and Blood Institute (NHLBI), University of Memphis
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The National Heart, Lung, and Blood Institute (NHLBI) created the Sickle Cell Disease Implementation Consortium (SCDIC) to apply implementation science methods to identify and address barriers to guideline-based care in sickle cell disease (SCD) and promote evidence-based treatment for SCD patients between ages 15 to 45 years. The SCDIC conducted a systematic literature review and a comprehensive needs assessment among the eight participating centers. A major conclusion was that care redesign to support better hydroxyurea utilization would likely improve clinical outcomes for patients with SCD. Hydroxyurea therapy has been shown to improve patient outcomes and reduce disease complications and is endorsed by the NHLBI. SCDIC now proposes to develop, test and evaluate targeted interventions to improve clinical provider prescribing of and patient adherence to hydroxyurea.
The overall purpose of this proposed project is to address barriers identified by the needs assessment to improve adherence with 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, via a stepped-wedge design, 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. 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. The investigators will examine among providers using the HU Toolbox App if there is an increase in reported awareness of hydroxyurea benefits and risks, accurate prescribing of hydroxyurea, and perceived self-efficacy to correctly administer hydroxyurea therapy between baseline and after 9 months of using the HU Toolbox app.
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. The investigators will evaluate the strategies used by participating sites in supporting the implementation of mHealth interventions via a mixed-method evaluation of the facilitators and barriers in adopting and implementing the mHealth interventions from multiple stakeholder perspectives: patient, provider, and organization.
Both mHealth interventions will be tested concurrently and because the investigators are using a stepped-wedge design, each site will enter the study at different times. Provider participants will receive the HU Toolbox intervention for 9 months with a lagged but overlapping introduction of the InCharge Health intervention patient participants for 24 weeks. The implementation evaluation will be guided by RE-AIM to assess the Reach, Effectiveness, Adoption, Implementation and Maintenance of the interventions. All sites will also complete follow-on needs assessment and medical record abstractions that will provide data to evaluate other patient and provider outcomes, barriers and enablers to hydroxyurea prescribing, use, and monitoring.
mHealth technology can be leveraged to support more effective use of hydroxyurea and eventually improved SCD clinical outcomes. If the mHealth applications tested in this study show preliminary efficacy, both apps could be scaled up within SCDIC centers and expanded to other institutions outside the SCDIC.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- nonrandomized, closed cohort, stepped-wedge cluster trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (InCharge Health app) | Other | Behavioral: InCharge Health mobile applicationPatient receives the InCharge Health app for 6 months |
| Arm 2 (HU Toolbox app) | Other | Behavioral: HU Toolbox mobile applicationProvider receives the HU Toolbox app for 9 months |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InCharge Health mobile applicationThe 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. | Behavioural | Arm 1 (InCharge Health app) |
| HU Toolbox mobile applicationThe 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. | Behavioural | Arm 2 (HU Toolbox app) |
Primary outcome
Mean Change in PDC From Baseline Through 24 Weeks
Time frame: baseline (prior to the intervention), week 24
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.
18 secondary outcomes
Implementation of InCharge Health App.
Time frame: baseline, 24 weeks
Change in Mean Corpuscular Volume (MCV)
Time frame: baseline, 24 weeks
Change in Fetal Hemoglobin
Time frame: baseline, 24 weeks
Change in Hemoglobin Concentration
Time frame: baseline, 24 weeks
Change in Reticulocyte Percentage
Time frame: baseline, 24 weeks
Change in Absolute Neutrophil Percentage
Time frame: baseline, 24 weeks
Change Bilirubin
Time frame: baseline, 24 weeks
Change in Mean Plasma Lactate Dehydrogenase (LDH)
Time frame: baseline, 24 weeks
Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks
Time frame: baseline, 24 weeks
Change in Rate of Hospitalization Per Patient in the Last 24 Weeks
Time frame: baseline, 24 weeks
Change in Patient Reported Pain Quality
Time frame: baseline, 24 weeks
Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale
Time frame: baseline, 24 weeks
Change in Patient Reported Pain Frequency and Severity
Time frame: baseline, 24 weeks
Change in Healthy Literacy
Time frame: baseline, 24 weeks
Change in Perceived Self-efficacy
Time frame: baseline, 24 weeks
Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines
Time frame: baseline, 9 months
Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines
Time frame: baseline, 9 months
Mean Change in PDC From Baseline Through 36 Weeks
Time frame: baseline (prior to the intervention), week 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36240004Badawy 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.
- Derived from this study: PubMed 37738155Hankins 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.
- Derived from this study: PubMed 32442144Hankins 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.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- ClinicalTrials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified patient-level data will be available to researchers outside the SCDIC through an application and approval process through BIOLINCC. To protect the confidentiality and privacy of the participants, investigators granted access to the limited access data must adhere to strict requirements incorporated into a standard Data Use Agreement. In accordance with NHLBI policy, outside researchers may also be required to submit an approval to BIOLINCC from their IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Hankins, MD principal investigator
St. Jude Children's Research Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InCharge Health mobile application and HU Toolbox mobile application in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in PDC From Baseline Through 24 Weeks (time frame: baseline (prior to the intervention), week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04080167, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.