Integration of mHEALTH Into the Care of Patients With Sic... | NCT04080167

ID	Type	Description	Link
5U01HL133996	U.S. NIH Grant/Contract		View source

Name	Class
RTI International	OTHER
National Heart, Lung, and Blood Institute (NHLBI)	NIH
University of Memphis	OTHER

Description Module

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.

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 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.

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.

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	baseline, 24 weeks
Change in Mean Corpuscular Volume (MCV)

Name	Affiliation	Role
Jane Hankins, MD	St. Jude Children's Research Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Georgia Regents University		Augusta	Georgia	30912	United States
University of Illinois

PubMed Identifier	Type	Citation	Retractions
36240004	Background	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.
37738155	Derived	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.

Label	URL
St. Jude Children's Research Hospital	View source

ID	Title	Description
FG000	Sites 1, 2 (InCharge Health App) Sickle Cell Disease (SCD) Patients	Sites 1 and 2 Patients: Enrolled 11/11/2019 to 7/17/2020. Data collected 11/11/2019 to 7/17/2020, 7/17/2020 to 12/30/2020 post-intervention data collected . Patient received the InCharge Health app for 6 months. InCharge Health mobile application features include: Daily reminders; customizable messages; Symptom tracker; streaks; Graphing adherence against pain symptoms; communication features; and an education bank. Provider received the HU Toolbox app for 9 months HU Toolbox mobile application: The HU Toolbox app includes algorithms for hydroxyurea use. In addition, it has the NHLBI guidelines, and has the ability to search for key words, add notes, print PDF documents, and contact local SCD specialists.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jul 22, 2020

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Of the 293 patients enrolled, 235 patients were analyzed. 21 were lost to follow-up, 13 were missing 24-week refill data, 12 had incomplete baseline refill data, 5 were new hydroxyurea starts, 3 involuntarily discontinued hydroxyurea, 2 died, and 2 were withdrawn from the study.

Posted

Mean

Standard Deviation

percentage of days

baseline (prior to the intervention), week 24

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Units	Counts
Participants	OG000235

Title

Denominators

Categories

Title	Measurements
	OG00016.3± 33.1

Secondary

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

293 participants data were analyzed.

Posted

Count of Participants

Participants

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients who used the InCharge Health app at least once during the study period. InCharge Health mobile application: The InCharge Health app was used for 6 months. Its 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.

Secondary

Change in Mean Corpuscular Volume (MCV)

Mean difference between MCV during the baseline interval and during the follow-up interval

Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data

Posted

Mean

Standard Deviation

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change in Fetal Hemoglobin

Mean difference between fetal hemoglobin during the baseline interval and during the follow-up interval

Of the 235 patients included in the outcome analysis, 137 patients were analyzed for this outcome as 98 had missing data

Posted

Mean

Standard Deviation

percentage of Hemoglobin F

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change in Hemoglobin Concentration

Mean difference between hemoglobin during the baseline interval and during the follow-up interval

Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data

Posted

Mean

Standard Deviation

g/dL

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change in Reticulocyte Percentage

Mean difference between reticulocyte percentage during the baseline interval and during the follow-up interval

Of the 235 patients included in the outcome analysis, 193 patients were analyzed for this outcome as 42 had missing data

Posted

Mean

Standard Deviation

percentage of reticulocytes

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change in Absolute Neutrophil Percentage

Mean difference between neutrophil percentage during the baseline interval and during the follow-up interval

Of the 235 patients included in the primary outcome analysis, 198 patients were analyzed for this outcome as 37 had missing data

Posted

Mean

Standard Deviation

percentage of neutrophils

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change Bilirubin

Mean difference between total bilirubin during the baseline interval and during the follow-up interval

Of the 235 patients included in the primary outcome analysis, 214 patients were analyzed for this outcome as 21 had missing data

Posted

Mean

Standard Deviation

mg/dL

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

Change in Mean Plasma Lactate Dehydrogenase (LDH)

Mean difference between LDH during the baseline interval and during the follow-up interval

Of the 235 patients included in the primary outcome analysis, 101 patients were analyzed for this outcome as 134 had missing data

Posted

Mean

Standard Deviation

IU/L

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks

Posted

Mean

Standard Deviation

emergency room visits per patient

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks

Posted

Mean

Standard Deviation

Number of hospitalizations per patients

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 182 patients were analyzed for this outcome as 53 had missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 183 patients were analyzed for this outcome as 52 had missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 24 weeks

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. Patient receives the InCharge Health app for 6 months 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.

Secondary

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.

69 of 89 providers analyzed because of missing data

Posted

Mean

Standard Deviation

number of correctly answered questions

baseline, 9 months

ID	Title	Description
OG000	Arm 2 (HU Toolbox App) - Providers	Physicians and advanced level practitioners meeting the eligibility requirements for the study. 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.

Secondary

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.

69 of 89 providers analyzed because of missing data

Posted

Mean

Standard Deviation

score on a scale

baseline, 9 months

ID	Title	Description
OG000	Arm 2 (HU Toolbox App) - Providers	Physicians and advanced level practitioners meeting the eligibility requirements for the study. 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.

Secondary

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.

Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data

Posted

Mean

Standard Deviation

percentage of days covered

baseline (prior to the intervention), week 36

ID	Title	Description
OG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Sickle cell patients meeting the eligibility requirements for the study. 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.

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006453	Hemoglobinopathies
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	Patient receives the InCharge Health app for 6 months 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.
BG001	Arm 2 (HU Toolbox App) - Providers	Provider receives the HU Toolbox app for 9 months 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.
BG002	Total	Total of all reporting groups