An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Enrolling

Conditions: Sickle Cell Hemoglobin C; Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia

Treatments: Behavioral: MED-Go App

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04688411

1K23HL150232 (U.S. NIH Grant/Contract)

IRB 2020-3367

Details and patient eligibility

About

The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.

Full description

Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea (HU), at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. AYA have adopted text messaging and smartphone apps at a fast pace, including those who have SCD.Existing evidence indicates that mobile health (mHealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in AYA, including SCD. The specific aim for this study is to test the feasibility and acceptability of the MED-Go app as an mHealth behavioral intervention to improve HU adherence among AYA with SCD.

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 12-21 years old
• Any sickle cell disease genotype
• On steady state of hydroxyurea for 2 months
• Own of have access to a smartphone during the study period

Exclusion criteria

• Recent hospitalizations within the past 7 days

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

MED-Go app Intervention

Other group

Description:

Participants will use MED-Go app intervention for a total of 12 weeks

Treatment:

Behavioral: MED-Go App

Control Arm

No Intervention group

Description:

Standard of care