Sickle Cell Disease
Conditions
Keywords
implementation science, sickle cell anemia, digital medicine, adherence, hydroxycarbamide, health innovation
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 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.
Interventions
BEHAVIORALInCharge 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.
BEHAVIORALHU 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.
Sponsors
RTI International
National Heart, Lung, and Blood Institute (NHLBI)
University of Memphis
St. Jude Children's Research Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
nonrandomized, closed cohort, stepped-wedge cluster trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in PDC From Baseline Through 24 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implementation of InCharge Health App. | baseline, 24 weeks | Count of all enrolled patients who used the InCharge Health app at least once during the study period among all enrolled |
| Change in Mean Corpuscular Volume (MCV) | baseline, 24 weeks | Mean difference between MCV during the baseline interval and during the follow-up interval |
| Change in Fetal Hemoglobin | baseline, 24 weeks | Mean difference between fetal hemoglobin during the baseline interval and during the follow-up interval |
| Change in Hemoglobin Concentration | baseline, 24 weeks | Mean difference between hemoglobin during the baseline interval and during the follow-up interval |
| Change in Reticulocyte Percentage | baseline, 24 weeks | Mean difference between reticulocyte percentage during the baseline interval and during the follow-up interval |
| Change in Absolute Neutrophil Percentage | baseline, 24 weeks | Mean difference between neutrophil percentage during the baseline interval and during the follow-up interval |
| Change Bilirubin | baseline, 24 weeks | Mean difference between total bilirubin during the baseline interval and during the follow-up interval |
| Change in Mean Plasma Lactate Dehydrogenase (LDH) | baseline, 24 weeks | Mean difference between LDH during the baseline interval and during the follow-up interval |
| Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks | baseline, 24 weeks | Mean difference between number of emergency room visits during the baseline interval and during the follow-up interval. |
| Change in Rate of Hospitalization Per Patient in the Last 24 Weeks | baseline, 24 weeks | Mean difference between number of hospitalizations during the baseline interval and during the follow-up interval. |
| Change in Patient Reported Pain Quality | baseline, 24 weeks | 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. |
| Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale | baseline, 24 weeks | 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. |
| Change in Patient Reported Pain Frequency and Severity | baseline, 24 weeks | 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. |
| Change in Healthy Literacy | baseline, 24 weeks | 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. |
| Change in Perceived Self-efficacy | baseline, 24 weeks | 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. |
| Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines | baseline, 9 months | 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. |
| Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines | baseline, 9 months | 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. |
| Mean Change in PDC From Baseline Through 36 Weeks | baseline (prior to the intervention), week 36 | 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. |
Countries
United States
Participant flow
Recruitment details
Between November 11, 2019 and September 3, 2021, three-hundred forty-three (343) participants were approached for enrollment, two-hundred ninety-three (293) patients consented and were enrolled on study. Eighty nine (89) providers were recruited and gave verbal consent for participation.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 293 |
| 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. | 89 |
| Total | 382 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death-Patient | 2 | 1 | 0 |
| Overall Study | Did not complete the baseline survey/activities | 0 | 4 | 0 |
| Overall Study | Hydroxyurea New Starts | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up-Patients | 7 | 14 | 0 |
| Overall Study | Lost to Follow-up-Providers | 2 | 2 | 0 |
| Overall Study | Withdrawal by Provider | 0 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Arm 2 (HU Toolbox App) - Providers | Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Total |
|---|---|---|---|
| Age, Customized 15-17 years | 0 Participants | 23 Participants | 23 Participants |
| Age, Customized 18-24 years | 0 Participants | 97 Participants | 97 Participants |
| Age, Customized 25-44 years | 53 Participants | 168 Participants | 221 Participants |
| Age, Customized 45-64 years | 28 Participants | 5 Participants | 33 Participants |
| Age, Customized 65 years and older | 5 Participants | 0 Participants | 5 Participants |
| Age, Customized Unknown | 3 Participants | 0 Participants | 3 Participants |
| Annual Income (n, %) $25,000 or less | — | 166 Participants | 166 Participants |
| Annual Income (n, %) $25,001-$50,000 | — | 60 Participants | 60 Participants |
| Annual Income (n, %) $50,001-$100,000+ | — | 40 Participants | 40 Participants |
| Annual Income (n, %) Missing | — | 27 Participants | 27 Participants |
| Education (n, %) College Graduate+ | — | 66 Participants | 66 Participants |
| Education (n, %) High school graduate or some college/vocational training | — | 176 Participants | 176 Participants |
| Education (n, %) Less than high school/Some high school | — | 43 Participants | 43 Participants |
| Education (n, %) Missing | — | 8 Participants | 8 Participants |
| Employment Employed | 0 Participants | 95 Participants | 95 Participants |
| Employment Missing | 0 Participants | 8 Participants | 8 Participants |
| Employment Not employed by choice (homemaker, student, retired) | 0 Participants | 75 Participants | 75 Participants |
| Employment Not employed, other (laid off/sick leave/maternity leave, unemployed, disabled) | 0 Participants | 115 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 84 Participants | 11 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 279 Participants | 282 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Marital Status Divorced/separated/widowed | 0 Participants | 11 Participants | 11 Participants |
| Marital Status Married/living as married | 0 Participants | 30 Participants | 30 Participants |
| Marital Status Missing | 0 Participants | 10 Participants | 10 Participants |
| Marital Status Never married | 0 Participants | 242 Participants | 242 Participants |
| Provider Type, n (%) Chose not to report | 4 Participants | — | 4 Participants |
| Provider Type, n (%) Nurse Practitioner or Physician Assistant | 36 Participants | — | 36 Participants |
| Provider Type, n (%) Physician | 49 Participants | — | 49 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 1 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 283 Participants | 307 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 2 Participants | 49 Participants |
| Sex/Gender, Customized Female | 65 Participants | 151 Participants | 216 Participants |
| Sex/Gender, Customized Male | 20 Participants | 141 Participants | 161 Participants |
| Sex/Gender, Customized Unknown | 4 Participants | 1 Participants | 5 Participants |
| Sickle cell disease genotype (n, %) HbSC/HbSβ+- thalassemia/other | 0 Participants | 46 Participants | 46 Participants |
| Sickle cell disease genotype (n, %) HbSS/HbSβ0-thalassemia | 0 Participants | 246 Participants | 246 Participants |
| Sickle cell disease genotype (n, %) Missing | — | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 293 |
| other Total, other adverse events | 0 / 293 |
| serious Total, serious adverse events | 0 / 293 |
Outcome results
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.
Time frame: baseline (prior to the intervention), week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Mean Change in PDC From Baseline Through 24 Weeks | 16.3 percentage of days | Standard Deviation 33.1 |
Secondary
Change Bilirubin
Mean difference between total bilirubin during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 214 patients were analyzed for this outcome as 21 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change Bilirubin | -0.09 mg/dL | Standard Deviation 0.1 |
Secondary
Change in Absolute Neutrophil Percentage
Mean difference between neutrophil percentage during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 198 patients were analyzed for this outcome as 37 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Absolute Neutrophil Percentage | 0.93 percentage of neutrophils | Standard Deviation 1.01 |
Secondary
Change in Fetal Hemoglobin
Mean difference between fetal hemoglobin during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the outcome analysis, 137 patients were analyzed for this outcome as 98 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Fetal Hemoglobin | 1.78 percentage of Hemoglobin F | Standard Deviation 0.76 |
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.
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 183 patients were analyzed for this outcome as 52 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Healthy Literacy | 0.05 score on a scale | Standard Deviation 1 |
Secondary
Change in Hemoglobin Concentration
Mean difference between hemoglobin during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Hemoglobin Concentration | 0.05 g/dL | Standard Deviation 0.07 |
Secondary
Change in Mean Corpuscular Volume (MCV)
Mean difference between MCV during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Mean Corpuscular Volume (MCV) | 0.70 fL | Standard Deviation 0.5 |
Secondary
Change in Mean Plasma Lactate Dehydrogenase (LDH)
Mean difference between LDH during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 101 patients were analyzed for this outcome as 134 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Mean Plasma Lactate Dehydrogenase (LDH) | -18.8 IU/L | Standard Deviation 18.5 |
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.
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Patient Reported Pain Frequency and Severity | 0 score on a scale | Standard Deviation 1.24 |
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.
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale | -0.005 score on a scale | Standard Deviation 1.09 |
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.
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 182 patients were analyzed for this outcome as 53 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Patient Reported Pain Quality | 0.15 score on a scale | Standard Deviation 0.15 |
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.
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Perceived Self-efficacy | -3.9 score on a scale | Standard Deviation 12.8 |
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.
Time frame: baseline, 9 months
Population: 69 of 89 providers analyzed because of missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines | 0.14 number of correctly answered questions | Standard Deviation 0.71 |
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.
Time frame: baseline, 24 weeks
Population: Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks | 0.35 emergency room visits per patient | Standard Deviation 1.94 |
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.
Time frame: baseline, 24 weeks
Population: Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Rate of Hospitalization Per Patient in the Last 24 Weeks | 0.01 Number of hospitalizations per patients | Standard Deviation 0.84 |
Secondary
Change in Reticulocyte Percentage
Mean difference between reticulocyte percentage during the baseline interval and during the follow-up interval
Time frame: baseline, 24 weeks
Population: Of the 235 patients included in the outcome analysis, 193 patients were analyzed for this outcome as 42 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change in Reticulocyte Percentage | -1.48 percentage of reticulocytes | Standard Deviation 0.49 |
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.
Time frame: baseline, 9 months
Population: 69 of 89 providers analyzed because of missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines | 0.07 score on a scale | Standard Deviation 1.71 |
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
Time frame: baseline, 24 weeks
Population: 293 participants data were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Implementation of InCharge Health App. | 240 Participants |
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.
Time frame: baseline (prior to the intervention), week 36
Population: Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients | Mean Change in PDC From Baseline Through 36 Weeks | 11.75 percentage of days covered | Standard Deviation 33.65 |