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

NCT04688411 | Recruiting

• 2 other identifiers: IRB 2020-33671K23HL150232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sickle cell disease; hydrxoyurea; mHealth intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Scores of System Usability Scale (SUS)

  12 weeks

• Hydroxyurea adherence rates

  12 weeks

Study Arms (2)

MED-Go app Intervention

OTHER

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

Behavioral: MED-Go App

Control Arm

NO INTERVENTION

Standard of care

Interventions

MED-Go App BEHAVIORAL

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

MED-Go app Intervention

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Recent hospitalizations within the past 7 days

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sherif M. Badawy, MD, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherif M Badawy, MD, MS

CONTACT

(312) 227-4836; sbadawy@luriechildrens.org

Savannah Winkler, BS

CONTACT

(312) 227-4807; swinkler@luriechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: September 28, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)