Integration of mHEALTH Into the Care of Patients With Sickle Cell Disease to Increase Hydroxyurea Utilization- mESH Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 382
- 试验地点
- 7
- 主要终点
- Mean Change in PDC From Baseline Through 24 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Arm 1 (InCharge Health app)
Patient receives the InCharge Health app for 6 months
干预措施: InCharge Health mobile application (Behavioral)
Arm 2 (HU Toolbox app)
Provider receives the HU Toolbox app for 9 months
干预措施: HU Toolbox mobile application (Behavioral)
结局指标
主要结局
Mean Change in PDC From Baseline Through 24 Weeks
时间窗: 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.
次要结局
- Change Bilirubin(baseline, 24 weeks)
- Change in Mean Plasma Lactate Dehydrogenase (LDH)(baseline, 24 weeks)
- Change in Rate of Emergency Room Visits Per Patient in the Last 24 Weeks(baseline, 24 weeks)
- Implementation of InCharge Health App.(baseline, 24 weeks)
- Change in Reticulocyte Percentage(baseline, 24 weeks)
- Change in Mean Corpuscular Volume (MCV)(baseline, 24 weeks)
- Change in Fetal Hemoglobin(baseline, 24 weeks)
- Change in Hemoglobin Concentration(baseline, 24 weeks)
- Change in Absolute Neutrophil Percentage(baseline, 24 weeks)
- Change in Rate of Hospitalization Per Patient in the Last 24 Weeks(baseline, 24 weeks)
- Change in Patient Reported Pain Quality(baseline, 24 weeks)
- Change in Patient Reported Pain Impact: ASCQ-Me Pain Impact Scale(baseline, 24 weeks)
- Change in Patient Reported Pain Frequency and Severity(baseline, 24 weeks)
- Change in Provider Knowledge of Hydroxyurea (HU) Prescription Guidelines(baseline, 9 months)
- Change is Provider Self-efficacy of Hydroxyurea (HU) Prescription Guidelines(baseline, 9 months)
- Change in Healthy Literacy(baseline, 24 weeks)
- Mean Change in PDC From Baseline Through 36 Weeks(baseline (prior to the intervention), week 36)
- Change in Perceived Self-efficacy(baseline, 24 weeks)