NCT04080167

Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization

Completed NA Results posted Last updated 29 November 2023

What this trial tests

NA trial testing InCharge Health mobile application in Sickle Cell Disease in 382 participants. Completed in 31 August 2022.

Timeline

11 November 2019

Primary endpoint
6 April 2022

31 August 2022

Quick facts

Lead sponsor	St. Jude Children's Research Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	health services research
Enrollment	382
Start date	11 November 2019
Primary completion	6 April 2022
Estimated completion	31 August 2022
Sites	7 locations across United States

Drugs / interventions tested

• InCharge Health mobile application
• HU Toolbox mobile application

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

St. Jude Children's Research Hospital

Who can join

Adults 15 to 45, any sex, with Sickle Cell Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in PDC From Baseline Through 24 Weeks Primary · 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.

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	16.3	± 33.1

Implementation of InCharge Health App. Secondary · baseline, 24 weeks

Count of all enrolled patients who used the InCharge Health app at least once during the study period among all enrolled

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	240

Change in Mean Corpuscular Volume (MCV) Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.70	± 0.50

Change in Fetal Hemoglobin Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	1.78	± 0.76

Change in Hemoglobin Concentration Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.05	± 0.07

Change in Reticulocyte Percentage Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	-1.48	± 0.49

Change in Absolute Neutrophil Percentage Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.93	± 1.01

Change Bilirubin Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	-0.09	± 0.10

Change in Mean Plasma Lactate Dehydrogenase (LDH) Secondary · baseline, 24 weeks

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

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	-18.8	± 18.5

Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks Secondary · baseline, 24 weeks

Mean difference between number of emergency room visits during the baseline interval and during the follow-up interval.

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.35	± 1.94

Change in Rate of Hospitalization Per Patient in the Last 24 Weeks Secondary · baseline, 24 weeks

Mean difference between number of hospitalizations during the baseline interval and during the follow-up interval.

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.01	± 0.84

Change in Patient Reported Pain Quality Secondary · 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.

Group	Value	95% CI
Arm 1 (InCharge Health App) - Sickle Cell Disease (SCD) Patients	0.15	± 0.15

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.