N/A
Completed N=382
Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization
Source: ClinicalTrials.gov NCT04080167 ↗Enrolled (actual)
382
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Mean Change in PDC From Baseline Through 24 Weeks — 16.3 percentage of days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in PDC From Baseline Through 24 Weeks |
16.3 | — |
| SECONDARY Implementation of InCharge Health App. |
240 | — |
| SECONDARY Change in Mean Corpuscular Volume (MCV) |
0.70 | — |
| SECONDARY Change in Fetal Hemoglobin |
1.78 | — |
| SECONDARY Change in Hemoglobin Concentration |
0.05 | — |
| SECONDARY Change in Reticulocyte Percentage |
-1.48 | — |
| SECONDARY Change in Absolute Neutrophil Percentage |
0.93 | — |
| SECONDARY Change Bilirubin |
-0.09 | — |
| SECONDARY Change in Mean Plasma Lactate Dehydrogenase (LDH) |
-18.8 | — |
| SECONDARY Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks |
0.35 | — |
| SECONDARY Change in Rate of Hospitalization Per Patient in the Last 24 Weeks |
0.01 | — |
| SECONDARY Change in Patient Reported Pain Quality |
0.15 | — |
| SECONDARY Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale |
-0.005 | — |
| SECONDARY Change in Patient Reported Pain Frequency and Severity |
— | — |
| SECONDARY Change in Healthy Literacy |
0.05 | — |
| SECONDARY Change in Perceived Self-efficacy |
-3.9 | — |
| SECONDARY Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines |
0.14 | — |
| SECONDARY Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines |
0.07 | — |
| SECONDARY Mean Change in PDC From Baseline Through 36 Weeks |
11.75 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04080167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.