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

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.

Study Overview

• Status: Recruiting
• Conditions: Sickle Cell Disease; Sickle B+ Thalassemia; Sickle Beta Zero Thalassemia; Sickle Cell Hemoglobin C
• Intervention / Treatment: Behavioral: MED-Go App

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherif M Badawy, MD, MS; Phone Number: (312) 227-4836; Email: sbadawy@luriechildrens.org
• Study Contact Backup: Name: Savannah Winkler, BS; Phone Number: (312) 227-4807; Email: swinkler@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H Lurie Children's Hospital of Chicago
      • Contact: Sherif M. Badawy, MD, MS; Phone Number: 312-227-4836; Email: sbadawy@luriechildrens.org
      • Principal Investigator: Sherif M. Badawy, MD, MS
      • Contact: Savannah Winkler, BS; Phone Number: (312) 227-4807; Email: swinkler@luriechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; Standard of care
Other: MED-Go app Intervention; Participants will use MED-Go app intervention for a total of 12 weeks	Behavioral: MED-Go App; A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving feasibility criteria of using the MED-Go app	Feasibility is defined as 70% of participants logging their daily HU 70% of the time over 12 weeks or 59 out of 84 study days. This will be reported as a dichotomous outcome, either yes or no.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of System Usability Scale (SUS)	App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)	12 weeks
Hydroxyurea adherence rates	Adherence rate is defined as number of given HU doses as recorded by the app divided by total number of doses during study period.	12 weeks

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Sherif M. Badawy, MD, MS, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: sickle cell disease; mHealth intervention; hydrxoyurea
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell; Thalassemia; Hemoglobin SC Disease
• Other Study ID Numbers: IRB 2020-3367; 1K23HL150232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All patient data will be deidentified

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No