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

NCT ID: NCT04688411

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2025-02-01

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MED-Go app Intervention

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

Group Type: OTHER

MED-Go App

Intervention Type: BEHAVIORAL

A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease

Control Arm

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MED-Go App

A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Sherif Badawy, MD

Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif M. Badawy, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sherif M Badawy, MD, MS

Role: CONTACT

sbadawy@luriechildrens.org

(312) 227-4836

Savannah Winkler, BS

Role: CONTACT

swinkler@luriechildrens.org

(312) 227-4807

Facility Contacts

Sherif M. Badawy, MD, MS

Role: primary

sbadawy@luriechildrens.org

312-227-4836

Savannah Winkler, BS

Role: backup

swinkler@luriechildrens.org

(312) 227-4807

Other Identifiers

1K23HL150232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB 2020-3367

Identifier Type: -

Identifier Source: org_study_id