Mobile Health Use Predicts Self-Efficacy and Self-Management in Adolescents with Sickle Cell Disease

Background: Sickle cell disease (SCD) is associated with medical challenges that often worsen for adolescents and young adults (AYA) when caregivers begin to transfer responsibility for care. Living with SCD requires self-management and self-efficacy and is a critical concern for AYA as they navigate complex medical systems. However, previous research indicates that AYA with SCD often lack the ability, confidence, and skills to manage their disease effectively. As most AYA with SCD are now "technology natives," mobile health (mHealth) holds considerable promise for assessing and changing behaviors to improve health outcomes. In a previous feasibility and acceptability study, AYA with SCD provided qualitative feedback that they would use mHealth (a co-designed mobile app) and that it was beneficial for tracking health behaviors. Thus, we integrated the mHealth app into a group intervention (SCThrive) and hypothesized that more engagement with the mHealth app would result in increased self-management and self-efficacy for AYA with SCD. Methods: Our analysis from a single-site, randomized control trial (NCT02851615) assessed data from only AYA in the treatment arm (N = 26) who received the SCThrive intervention and used the mHealth app. The sample included AYA with SCD aged 13 to 21 years (Mage = 16.7 years; 54% female; 46% HbSS genotype; all African American/Black) who received six-weekly group sessions (3 in-person, 3 online). All SCThrive participants were provided with the mobile app (iManage) on an iPad. The Transition Readiness Assessment Questionnaire (TRAQ-5) assessed self-management skills and the Patient Activation Measure (PAM-13) assessed self-efficacy at baseline and posttreatment. We also assessed engagement (logins), confidence and completion of self-management goals (e.g., exercising, take medications), pain diary entries, and mood symptoms recorded on the iManage app (see Figure 1). Results: Preliminary analyses indicated that most AYA with SCD logged on to the iManage app (Mlogins = 7.8, SD = 9.1, range = 1 - 45) and viewed their pain diary (Mviews = 5.7, SD = 9.1, range = 1 - 45) at least once a week. Eighty-eight percent of AYA saved a pain diary entry and the most commonly used strategies for managing pain episodes were resting (22%), drinking water (19%), and using distraction (8%). AYA viewed their self-management goals about once every 11 days (Mdays = 11.24, SD = 13, range = 0 - 57). All AYA created (Mgoals = 5.7, SD = .72, range = 4 - 7), but only 54% of AYA completed at least one self-management goal. Of the 149 self-management goals created by the entire sample, only 37 (25%) were recorded as completed. AYA with a confidence level of 7 or lower were least likely to complete their self-management goals (14%) (see Figure 2). Correlation analyses demonstrated that logging on to the iManage app more frequently was associated with completing more self-management goals (r = .38), documenting pain symptoms more frequently (r = .54), and lower mood ratings (r = .54). Primary analyses demonstrated that after controlling for scores at baseline, the number of logins to the iManage app (p = .08, η2 = .13) predicted self-efficacy (PAM-13) and (p = .05, η2 = .17) self-management skills (TRAQ-5). Completing more self-management goals on the iManage app did not predict scores on the PAM-13, but, surprisingly, predicted lower scores (less self-management) on the TRAQ-5 (p = .08, η2 = .14). Conclusion: Lessons learned from our study indicate that it can be challenging to maintain engagement in mHealth for AYA with SCD, but for those who do engage there are significant benefits related to self-management goals, documenting pain symptoms, and mood. Supporting hypotheses, engaging more with the iManage app was related to higher-reported self-efficacy and self-management skills. Some AYA engaged with the app infrequently and did not create or complete self-management goals; others were "super users" and logged into the app daily. Increasing the frequency of reminder messages, encouraging more interactions with peers, and tailoring the opportunity to earn incentives are potential modifications for future interventions. However, our findings indicate that a mHealth app can be effectively integrated into a clinical trial and is related to positive outcomes. Although there are challenges to address, mHealth has the potential to bring about changes in behavior and improve health in the SCD population. Disclosures No relevant conflicts of interest to declare.

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Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study

JMIR Research Protocols ◽

10.2196/16319 ◽

2020 ◽

Vol 9 (7) ◽

pp. e16319

Author(s):

Jane S Hankins ◽

Nirmish Shah ◽

Lisa DiMartino ◽

Donald Brambilla ◽

Maria E Fernandez ◽

...

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Mobile Health ◽

Self Efficacy ◽

Large Scale ◽

Cell Disease ◽

Prescribing Behavior ◽

Blood Institute ◽

Mhealth Intervention ◽

Knowledge Barriers

Background Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. Objective This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. Methods We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. Results The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. Conclusions If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. Trial Registration ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 International Registered Report Identifier (IRRID) DERR1-10.2196/16319

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The Effectiveness of Self-Management Programs on Self-Efficacy in Patients With Sickle Cell Disease

Jundishapur Journal of Chronic Disease Care ◽

10.17795/jjcdc-21702 ◽

2014 ◽

Vol 3 (3) ◽

Cited By ~ 3

Author(s):

Mehrnaz Ahmadi ◽

Abdolali Shariati ◽

Simin Jahani ◽

Hamed Tabesh ◽

Bijan Keikhaei

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Self Efficacy ◽

Self Management ◽

Cell Disease

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Assessing Disease Knowledge and Self-Management in Youth With Sickle Cell Disease Prior to Transition

Journal of Pediatric Oncology Nursing ◽

10.1177/1043454218819447 ◽

2018 ◽

Vol 36 (2) ◽

pp. 143-149 ◽

Cited By ~ 1

Author(s):

Barbara Speller-Brown ◽

Maureen Varty ◽

Lisa Thaniel ◽

Marni B. Jacobs

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Basic Knowledge ◽

Self Management ◽

Medical Attention ◽

Age Group ◽

Cell Disease ◽

Management Skills ◽

Disease Knowledge ◽

Baseline Hemoglobin

Introduction: Transition of medical care from pediatrics to adult can be challenging and difficult. Until the 1970s, only half of patients diagnosed with sickle cell disease (SCD) reached adulthood. As a result of patients living longer, there is a growing need to understand factors that influence readiness to transition. This descriptive study examined age-specific SCD knowledge, self-management skills of patients, and education goals in a convenience sample of patients and their parents. Method: One hundred eighty-three transition surveys were distributed during scheduled hematology clinic visits. Surveys were analyzed with descriptive statistics to determine differences of knowledge between age groups, self-care skills, vocational supports, and educational goals. The parent group consists of children aged 0 to 4 years (32), 5 to 8 years (52), 9 to 11 years (12); the child group consists of children aged 9 to 11 years (24) and 12 to 15 years (31); and adolescent and young adult (AYA) group consists of children aged 16 to 21 years (32). Results: Indeed, 50% of parents of the 0 to 4 years age group and 33% of 5 to 8 years age group knew their child’s baseline hemoglobin. Only 38% of patients aged 16 to 21 years knew their baseline hemoglobin. However, 79% of patients aged 9 to 11 years, 74% of patient aged 12 to 15 years, and 78% of AYAs could name their hematology provider. Only 66% of patients aged 16 to 21 years knew what symptoms required medical attention. Discussion: Most patients and parents had adequate basic knowledge regarding SCD. AYAs lack the disease knowledge necessary to transition care away from parents to become more independent. An assessment for transition readiness should be ongoing to include disease-specific knowledge and self-management skills.

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Decision-making involvement, self-efficacy, and the relationship to transition readiness in youth with sick cell disease

10.32469/10355/79494 ◽

2020 ◽

Author(s):

◽

Maureen M. Varty

Keyword(s):

Decision Making ◽

Parent Involvement ◽

Sickle Cell Disease ◽

Sickle Cell ◽

Self Efficacy ◽

Self Management ◽

Cell Disease ◽

Specific Knowledge ◽

Transition Readiness ◽

Healthcare Settings

Transition from pediatric to adult healthcare settings poses significant risks to morbidity and mortality for adolescents and young adults with sickle cell disease. Increasing transition readiness, the acquisition of disease-specific knowledge and self-management skills, has been proposed as strategy to improve health outcomes for adolescents and young adults (AYA) after transition. To date, few studies have looked at factors that may influence transition readiness, a measure of disease-specific knowledge and self-management, in AYAs with sickle cell disease. This limits healthcare providers' and researchers' abilities to develop interventions specific to the unique needs of the population. This dissertation study examined the relationships between decision-making involvement, self-efficacy of sickle cell disease self-management, and transition readiness in AYAs with sickle cell disease prior to transition to adult healthcare settings. This study found that higher levels of expressive behaviors such as sharing opinions and ideas in decision-making were associated with higher levels of AYA healthcare responsibility. Self-efficacy was positively associated with transition readiness but inversely related to AYA healthcare responsibility. Parent involvement was negatively associated with AYA healthcare responsibility. Future research interventions that increase AYA involvement in decision-making regarding disease management, increase self-efficacy, and safely reduce parent involvement may positively influence their capacity for self-management.

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Toward a Conversational Agent to Support the Self-Management of Adults and Young Adults With Sickle Cell Disease: Usability and Usefulness Study

Frontiers in Digital Health ◽

10.3389/fdgth.2021.600333 ◽

2021 ◽

Vol 3 ◽

Author(s):

David-Zacharie Issom ◽

Marie-Dominique Hardy-Dessources ◽

Marc Romana ◽

Gunnar Hartvigsen ◽

Christian Lovis

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Self Efficacy ◽

Self Care ◽

Health Coaching ◽

Self Management ◽

Behavior Changes ◽

Cell Disease ◽

Blood Disorder ◽

System Usability Scale

Sickle cell disease (SCD) is the most common genetic blood disorder in the world and affects millions of people. With aging, patients encounter an increasing number of comorbidities that can be acute, chronic, and potentially lethal (e.g., pain, multiple organ damages, lung disease). Comprehensive and preventive care for adults with SCD faces disparities (e.g., shortage of well-trained providers). Consequently, many patients do not receive adequate treatment, as outlined by evidence-based guidelines, and suffer from mistrust, stigmatization or neglect. Thus, adult patients often avoid necessary care, seek treatment only as a last resort, and rely on self-management to maintain control over the course of the disease. Hopefully, self-management positively impacts health outcomes. However, few patients possess the required skills (e.g., disease-specific knowledge, self-efficacy), and many lack motivation for effective self-care. Health coaching has emerged as a new approach to enhance patients' self-management and support health behavior changes. Recent studies have demonstrated that conversational agents (chatbots) could effectively support chronic patients' self-management needs, improve self-efficacy, encourage behavior changes, and reduce disease-severity. To date, the use of chatbots to support SCD self-management remains largely under-researched. Consequently, we developed a high-fidelity prototype of a fully automated health coaching chatbot, following patient-important requirements and preferences collected during our previous work. We recruited a small convenience sample of adults with SCD to examine the usability and perceived usefulness of the system. Participants completed a post-test survey using the System Usability Scale and the Usefulness Scale for Patient Information Material questionnaire. Thirty-three patients participated. The majority (64%) was affected by the most clinically severe SCD genotypes (Hb SS, HbSβ0). Most participants (94%) rated the chatbots as easy and fun to use, while 88% perceived it as useful support for patient empowerment. In the qualitative phase, 72% of participants expressed their enthusiasm using the chatbot, and 82% emphasized its ability to improve their knowledge about self-management. Findings suggest that chatbots could be used to promote the acquisition of recommended health behaviors and self-care practices related to the prevention of the main symptoms of SCD. Further work is needed to refine the system, and to assess clinical validity.

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Factors Influencing Motivation and Engagement in Mobile Health Among Patients With Sickle Cell Disease in Low-Prevalence, High-Income Countries: Qualitative Exploration of Patient Requirements (Preprint)

10.2196/preprints.14599 ◽

2019 ◽

Author(s):

David-Zacharie Issom ◽

André Henriksen ◽

Ashenafi Zebene Woldaregay ◽

Jessica Rochat ◽

Christian Lovis ◽

...

Keyword(s):

Chronic Disease ◽

Sickle Cell Disease ◽

Mobile Health ◽

Care Management ◽

Self Care ◽

High Income ◽

Self Management ◽

Cell Disease ◽

Low Prevalence ◽

To Receive

BACKGROUND Sickle cell disease (SCD) is a hematological genetic disease affecting over 25 million people worldwide. The main clinical manifestations of SCD, hemolytic anemia and vaso-occlusion, lead to chronic pain and organ damages. With recent advances in childhood care, high-income countries have seen SCD drift from a disease of early childhood mortality to a neglected chronic disease of adulthood. In particular, coordinated, preventive, and comprehensive care for adults with SCD is largely underresourced. Consequently, patients are left to self-manage. Mobile health (mHealth) apps for chronic disease self-management are now flooding app stores. However, evidence remains unclear about their effectiveness, and the literature indicates low user engagement and poor adoption rates. Finally, few apps have been developed for people with SCD and none encompasses their numerous and complex self-care management needs. OBJECTIVE This study aimed to identify factors that may influence the long-term engagement and user adoption of mHealth among the particularly isolated community of adult patients with SCD living in low-prevalence, high-income countries. METHODS Semistructured interviews were conducted. Interviews were audiotaped, transcribed verbatim, and analyzed using thematic analysis. Analysis was informed by the Braun and Clarke framework and mapped to the COM-B model (capability, opportunity, motivation, and behavior). Results were classified into high-level functional requirements (FRs) and nonfunctional requirements (NFRs) to guide the development of future mHealth interventions. RESULTS Overall, 6 males and 4 females were interviewed (aged between 21 and 55 years). Thirty FRs and 31 NFRs were extracted from the analysis. Most participants (8/10) were concerned about increasing their physical capabilities being able to stop pain symptoms quickly. Regarding the psychological capability aspects, all interviewees desired to receive trustworthy feedback on their self-care management practices. About their physical opportunities, most (7/10) expressed a strong desire to receive alerts when they would reach their own physiological limitations (ie, during physical activity). Concerning social opportunity, most (9/10) reported wanting to learn about the self-care practices of other patients. Relating to motivational aspects, many interviewees (6/10) stressed their need to learn how to avoid the symptoms and live as normal a life as possible. Finally, NFRs included inconspicuousness and customizability of user experience, automatic data collection, data shareability, and data privacy. CONCLUSIONS Our findings suggest that motivation and engagement with mHealth technologies among the studied population could be increased by providing features that clearly benefit them. Self-management support and self-care decision aid are patients’ major demands. As the complexity of SCD self-management requires a high cognitive load, pervasive health technologies such as wearable sensors, implantable devices, or inconspicuous conversational user interfaces should be explored to ease it. Some of the required technologies already exist but must be integrated, bundled, adapted, or improved to meet the specific needs of people with SCD.

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Six-Month Data From a Pilot Self-Management Intervention ForAdolescents With Sickle Cell Disease

Blood ◽

10.1182/blood.v122.21.1675.1675 ◽

2013 ◽

Vol 122 (21) ◽

pp. 1675-1675 ◽

Cited By ~ 1

Author(s):

Lori E Crosby ◽

Naomi Joffe ◽

Karen Kalinyak ◽

Alex Bruck ◽

Clinton H Joiner

Keyword(s):

Quality Of Life ◽

Sickle Cell ◽

Self Efficacy ◽

The Self ◽

Self Management ◽

Cell Disease ◽

Management Skills ◽

Post Intervention ◽

Management Behaviors

Abstract Background Tanabe and colleagues (2010) highlighted the importance of engaging patients with Sickle Cell Disease (SCD) in disease self-management activities to improve health outcomes. Specifically, they recommended interventions that address disease self-efficacy, patient-provider communication, healthy lifestyle behaviors, future planning, and advocacy. The Stanford Chronic Disease Self-Management Program (CDSMP) is a six-week, structured intervention for adults with a chronic disease that helps them develop self-management skills in all of these areas. The CDSMP has been implemented with adults with a variety of chronic diseases (e.g., arthritis, Type II diabetes), and outcome data has shown improvements in health utilization, health status and self-management behaviors for participants six-months post participation in the CDSMP (Lorig et al. 2001). There is limited data available on the effectiveness of the CDSMP for adults with SCD, particularly young adults and adolescents. As a first step in examining the effectiveness of the CDSMP in adolescents with SCD, we conducted two CDSMP intervention groups with SCD patients 16-24 years of age. Objective The objective of the study was to assess: 1) the feasibility, acceptability and utility of the CDSMP with this population, and, 2) changes in disease self-efficacy, quality of life (QOL), and self-management behaviors from pre to 6-months after participation in the CDSMP. Methods Patients were eligible if they: 1) had a diagnosis of SCD; 2) were followed by the University of Cincinnati Health Complex or Cincinnati Children’s Hospital Medical Center (CCHMC) sickle cell clinics; 3) were between the ages of 16 -24; and, 4) had no significant cognitive limitations. Participants received a letter followed by a phone call inviting them to participate in the CDSMP and were compensated at the end of each weekly session. Results Eighteen adolescents completed the CDSMP (i.e., attended four of the six sessions) and have completed their 6-month follow-up. The majority of patients were female (56%) and had Hb SS (SS 67%; SC 28%; Sβ+Thal 5%); the mean age for participants was 19.06 (SD = 2.44). Acceptability data indicated that sessions 2 and 6 (physical activity and exercise, managing difficult emotions, working with your healthcare provider, and planning for the future) were the most beneficial. Overall participant satisfaction with the CDSMP was high, M=8.88 (SD=1.67) on a scale of 1-10 (10=totally satisfied). Qualitative comments suggest that the participants enjoyed interacting with other patients and learning skills to help manage their illness. Repeated measures ANOVAs were used to examine the QOL and disease self-efficacy data. There was not a significant improvement on PedsQL total scores over time. Patient-reported disease self-efficacy scores showed a positive trend (F(1.572, 9.432) = 3.442, P = .083). Participants reported continuing to use a number of the self-management skills/strategies they learned during the intervention such as better breathing (86.7%), problem solving (73.3%), and action planning (66.7%). Discussion Initial Results from this small pilot suggest that the CDSMP may have some promising benefits as an intervention for adolescents and young adults with SCD given its feasibility, acceptability, and potential impact on disease self-efficacy and utilization of skills learned. In addition to participants being satisfied with the content, structure, and opportunity to interact with other participants, they also reported that they continued to use the self-management skills that they had developed. Disease self-efficacy also trended upwards for participants over the course of the intervention. Although improvements in quality of life were not observed at six-months post-intervention, the small sample size likely had an impact. The next steps will be to examine these outcomes for the duration of the post-intervention period (i.e., nine and twelve-month follow-ups) to determine whether the improvements in disease self-efficacy are maintained and whether we see quality of life improving once analyses are completed with a more complete sample size. Disclosures: No relevant conflicts of interest to declare.

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The Adolescent and Caregiver Sickle Cell Disease Self-management Skills Checklist

Journal of Pediatric Hematology/Oncology ◽

10.1097/mph.0000000000001618 ◽

2020 ◽

Vol 42 (1) ◽

pp. 12-19 ◽

Cited By ~ 1

Author(s):

Megan Loew ◽

Justin L. Williams ◽

Kathryn Russell ◽

Rebecca Rupff ◽

Jane S. Hankins ◽

...

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Self Management ◽

Cell Disease ◽

Management Skills

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Preferences for Using a Mobile App in Sickle Cell Disease Self-Management: A Descriptive Qualitative Study (Preprint)

JMIR Formative Research ◽

10.2196/28678 ◽

2021 ◽

Author(s):

Tilicia Mayo-Gamble ◽

Delores Quasie-Woode ◽

Jennifer Cunningham-Erves ◽

Margo Rollins ◽

David Schlundt ◽

...

Keyword(s):

Sickle Cell Disease ◽

Qualitative Study ◽

Sickle Cell ◽

Mobile App ◽

Self Management ◽

Cell Disease ◽

Descriptive Qualitative

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Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study (Preprint)

10.2196/preprints.16319 ◽

2019 ◽

Cited By ~ 1

Author(s):

Jane S Hankins ◽

Nirmish Shah ◽

Lisa DiMartino ◽

Donald Brambilla ◽

Maria E Fernandez ◽

...

Keyword(s):

Sickle Cell Disease ◽

Sickle Cell ◽

Mobile Health ◽

Self Efficacy ◽

Large Scale ◽

Cell Disease ◽

Prescribing Behavior ◽

Blood Institute ◽

Mhealth Intervention ◽

Knowledge Barriers

BACKGROUND Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. OBJECTIVE This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. METHODS We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. RESULTS The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. CONCLUSIONS If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. CLINICALTRIAL ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16319

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