Trial Outcomes & Findings for Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization (NCT NCT04080167)
NCT ID: NCT04080167
Last Updated: 2023-11-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
382 participants
Primary outcome timeframe
baseline (prior to the intervention), week 24
Results posted on
2023-11-29
Participant Flow
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.
Unit of analysis: SCDIC Study Sites
Participant milestones
| Measure |
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.
|
Sites 3, 4 (InCharge Health App) Sickle Cell Disease (SCD) Patients
Sites 3 and 4 Patients: Enrolled 6/11/2020 to 9/3/2021. Data collected 6/11/2020 to 9/3/2021 to 5/17/22 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.
|
Sites 5, 6, 7 (InCharge Health App) Sickle Cell Disease (SCD) Patients
Sites 5, 6 and 7 Patients: Enrolled 1/5/2021 to 9/3/2021. Data collected 1/5/2021 to 11/3/2021, 11/3/2021 to 7/7/2023 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
136 2
|
99 2
|
147 3
|
|
Overall Study
Patients-All Enrolled
|
94 2
|
88 2
|
111 3
|
|
Overall Study
Providers-All Enrolled
|
42 2
|
11 2
|
36 3
|
|
Overall Study
Patients-Completed
|
84 2
|
67 2
|
110 3
|
|
Overall Study
Providers-Completed
|
40 2
|
9 2
|
32 3
|
|
Overall Study
COMPLETED
|
124 2
|
76 2
|
142 3
|
|
Overall Study
NOT COMPLETED
|
12 0
|
23 0
|
5 0
|
Reasons for withdrawal
| Measure |
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.
|
Sites 3, 4 (InCharge Health App) Sickle Cell Disease (SCD) Patients
Sites 3 and 4 Patients: Enrolled 6/11/2020 to 9/3/2021. Data collected 6/11/2020 to 9/3/2021 to 5/17/22 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.
|
Sites 5, 6, 7 (InCharge Health App) Sickle Cell Disease (SCD) Patients
Sites 5, 6 and 7 Patients: Enrolled 1/5/2021 to 9/3/2021. Data collected 1/5/2021 to 11/3/2021, 11/3/2021 to 7/7/2023 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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up-Patients
|
7
|
14
|
0
|
|
Overall Study
Lost to Follow-up-Providers
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Provider
|
0
|
0
|
4
|
|
Overall Study
Death-Patient
|
2
|
1
|
0
|
|
Overall Study
Hydroxyurea New Starts
|
0
|
0
|
1
|
|
Overall Study
Did not complete the baseline survey/activities
|
0
|
4
|
0
|
Baseline Characteristics
Data for Sickle cell disease genotype collected for patient participants only.
Baseline characteristics by cohort
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=293 Participants
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.
|
Arm 2 (HU Toolbox App) - Providers
n=89 Participants
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.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15-17 years
|
23 Participants
n=293 Participants
|
0 Participants
n=89 Participants
|
23 Participants
n=382 Participants
|
|
Age, Customized
18-24 years
|
97 Participants
n=293 Participants
|
0 Participants
n=89 Participants
|
97 Participants
n=382 Participants
|
|
Age, Customized
25-44 years
|
168 Participants
n=293 Participants
|
53 Participants
n=89 Participants
|
221 Participants
n=382 Participants
|
|
Age, Customized
45-64 years
|
5 Participants
n=293 Participants
|
28 Participants
n=89 Participants
|
33 Participants
n=382 Participants
|
|
Age, Customized
65 years and older
|
0 Participants
n=293 Participants
|
5 Participants
n=89 Participants
|
5 Participants
n=382 Participants
|
|
Age, Customized
Unknown
|
0 Participants
n=293 Participants
|
3 Participants
n=89 Participants
|
3 Participants
n=382 Participants
|
|
Sex/Gender, Customized
Female
|
151 Participants
n=293 Participants
|
65 Participants
n=89 Participants
|
216 Participants
n=382 Participants
|
|
Sex/Gender, Customized
Male
|
141 Participants
n=293 Participants
|
20 Participants
n=89 Participants
|
161 Participants
n=382 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=293 Participants
|
4 Participants
n=89 Participants
|
5 Participants
n=382 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=293 Participants
|
84 Participants
n=89 Participants
|
95 Participants
n=382 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
279 Participants
n=293 Participants
|
3 Participants
n=89 Participants
|
282 Participants
n=382 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=293 Participants
|
2 Participants
n=89 Participants
|
5 Participants
n=382 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=293 Participants
|
2 Participants
n=89 Participants
|
4 Participants
n=382 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=293 Participants
|
16 Participants
n=89 Participants
|
17 Participants
n=382 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=293 Participants
|
0 Participants
n=89 Participants
|
3 Participants
n=382 Participants
|
|
Race (NIH/OMB)
Black or African American
|
283 Participants
n=293 Participants
|
24 Participants
n=89 Participants
|
307 Participants
n=382 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=293 Participants
|
47 Participants
n=89 Participants
|
49 Participants
n=382 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=293 Participants
|
0 Participants
n=89 Participants
|
0 Participants
n=382 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=293 Participants
|
0 Participants
n=89 Participants
|
2 Participants
n=382 Participants
|
|
Sickle cell disease genotype (n, %)
HbSS/HbSβ0-thalassemia
|
246 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
0 Participants
Data for Sickle cell disease genotype collected for patient participants only.
|
246 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
|
Sickle cell disease genotype (n, %)
HbSC/HbSβ+- thalassemia/other
|
46 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
0 Participants
Data for Sickle cell disease genotype collected for patient participants only.
|
46 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
|
Sickle cell disease genotype (n, %)
Missing
|
1 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
—
|
1 Participants
n=293 Participants • Data for Sickle cell disease genotype collected for patient participants only.
|
|
Marital Status
Married/living as married
|
30 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
0 Participants
Data for Marital Status collected for patient participants only.
|
30 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
|
Marital Status
Never married
|
242 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
0 Participants
Data for Marital Status collected for patient participants only.
|
242 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
|
Marital Status
Divorced/separated/widowed
|
11 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
0 Participants
Data for Marital Status collected for patient participants only.
|
11 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
|
Marital Status
Missing
|
10 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
0 Participants
Data for Marital Status collected for patient participants only.
|
10 Participants
n=293 Participants • Data for Marital Status collected for patient participants only.
|
|
Education (n, %)
Less than high school/Some high school
|
43 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
—
|
43 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
|
Education (n, %)
High school graduate or some college/vocational training
|
176 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
—
|
176 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
|
Education (n, %)
College Graduate+
|
66 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
—
|
66 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
|
Education (n, %)
Missing
|
8 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
—
|
8 Participants
n=293 Participants • Data for Education collected for patient participants only.
|
|
Employment
Employed
|
95 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
0 Participants
Data for Employment collected for patient participants only.
|
95 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
|
Employment
Not employed by choice (homemaker, student, retired)
|
75 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
0 Participants
Data for Employment collected for patient participants only.
|
75 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
|
Employment
Not employed, other (laid off/sick leave/maternity leave, unemployed, disabled)
|
115 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
0 Participants
Data for Employment collected for patient participants only.
|
115 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
|
Employment
Missing
|
8 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
0 Participants
Data for Employment collected for patient participants only.
|
8 Participants
n=293 Participants • Data for Employment collected for patient participants only.
|
|
Annual Income (n, %)
$25,000 or less
|
166 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
—
|
166 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
|
Annual Income (n, %)
$25,001-$50,000
|
60 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
—
|
60 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
|
Annual Income (n, %)
$50,001-$100,000+
|
40 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
—
|
40 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
|
Annual Income (n, %)
Missing
|
27 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
—
|
27 Participants
n=293 Participants • Data for Annual Income collected for patient participants only.
|
|
Provider Type, n (%)
Physician
|
—
|
49 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
49 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
|
Provider Type, n (%)
Nurse Practitioner or Physician Assistant
|
—
|
36 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
36 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
|
Provider Type, n (%)
Chose not to report
|
—
|
4 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
4 Participants
n=89 Participants • Data for Provider Type collected for providers only.
|
PRIMARY outcome
Timeframe: baseline (prior to the intervention), week 24Population: 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.
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=235 Participants
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.
|
|---|---|
|
Mean Change in PDC From Baseline Through 24 Weeks
|
16.3 percentage of days
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: 293 participants data were analyzed.
Count of all enrolled patients who used the InCharge Health app at least once during the study period among all enrolled
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=293 Participants
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.
|
|---|---|
|
Implementation of InCharge Health App.
|
240 Participants
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data
Mean difference between MCV during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=228 Participants
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.
|
|---|---|
|
Change in Mean Corpuscular Volume (MCV)
|
0.70 fL
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the outcome analysis, 137 patients were analyzed for this outcome as 98 had missing data
Mean difference between fetal hemoglobin during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=137 Participants
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.
|
|---|---|
|
Change in Fetal Hemoglobin
|
1.78 percentage of Hemoglobin F
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the outcome analysis, 228 patients were analyzed for this outcome as 7 had missing data
Mean difference between hemoglobin during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=228 Participants
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.
|
|---|---|
|
Change in Hemoglobin Concentration
|
0.05 g/dL
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the outcome analysis, 193 patients were analyzed for this outcome as 42 had missing data
Mean difference between reticulocyte percentage during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=193 Participants
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.
|
|---|---|
|
Change in Reticulocyte Percentage
|
-1.48 percentage of reticulocytes
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 198 patients were analyzed for this outcome as 37 had missing data
Mean difference between neutrophil percentage during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=198 Participants
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.
|
|---|---|
|
Change in Absolute Neutrophil Percentage
|
0.93 percentage of neutrophils
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 214 patients were analyzed for this outcome as 21 had missing data
Mean difference between total bilirubin during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=214 Participants
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.
|
|---|---|
|
Change Bilirubin
|
-0.09 mg/dL
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 101 patients were analyzed for this outcome as 134 had missing data
Mean difference between LDH during the baseline interval and during the follow-up interval
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=101 Participants
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.
|
|---|---|
|
Change in Mean Plasma Lactate Dehydrogenase (LDH)
|
-18.8 IU/L
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks
Mean difference between number of emergency room visits during the baseline interval and during the follow-up interval.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=235 Participants
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.
|
|---|---|
|
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 outcome
Timeframe: baseline, 24 weeksPopulation: Of the 293 patients enrolled, 235 patients were analyzed for this outcome as 58 did not complete the 24 weeks
Mean difference between number of hospitalizations during the baseline interval and during the follow-up interval.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=235 Participants
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.
|
|---|---|
|
Change in Rate of Hospitalization Per Patient in the Last 24 Weeks
|
0.01 Number of hospitalizations per patients
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 182 patients were analyzed for this outcome as 53 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=182 Participants
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.
|
|---|---|
|
Change in Patient Reported Pain Quality
|
0.15 score on a scale
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=187 Participants
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.
|
|---|---|
|
Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale
|
-0.005 score on a scale
Standard Deviation 1.090
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 187 patients were analyzed for this outcome as 48 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=187 Participants
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.
|
|---|---|
|
Change in Patient Reported Pain Frequency and Severity
|
0 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 183 patients were analyzed for this outcome as 52 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=183 Participants
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.
|
|---|---|
|
Change in Healthy Literacy
|
0.05 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: baseline, 24 weeksPopulation: Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=232 Participants
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.
|
|---|---|
|
Change in Perceived Self-efficacy
|
-3.9 score on a scale
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: baseline, 9 monthsPopulation: 69 of 89 providers analyzed because of missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=69 Participants
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.
|
|---|---|
|
Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines
|
0.14 number of correctly answered questions
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: baseline, 9 monthsPopulation: 69 of 89 providers analyzed because of missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=69 Participants
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.
|
|---|---|
|
Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines
|
0.07 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: baseline (prior to the intervention), week 36Population: Of the 235 patients included in the primary outcome analysis, 232 patients were analyzed for this outcome as 2 had missing data
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.
Outcome measures
| Measure |
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
n=232 Participants
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.
|
|---|---|
|
Mean Change in PDC From Baseline Through 36 Weeks
|
11.75 percentage of days covered
Standard Deviation 33.65
|
Adverse Events
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jane Hankins, MD
St. Jude Children's Research Hospital
Phone: (901) 595-4974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place