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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688411
• Other study ID #: IRB 2020-3367
• Secondary ID: 1K23HL150232
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 1, 2024

Study information

• Verified date: September 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Sherif M Badawy, MD, MS
• Phone: (312) 227-4836
• Email: sbadawy[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Hemoglobin SC Disease
• Sickle B+ Thalassemia
• Sickle Beta Zero Thalassemia
• Sickle Cell Disease
• Sickle Cell Hemoglobin C
• Thalassemia

Intervention

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

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Scores of System Usability Scale (SUS)	App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)	12 weeks
Secondary	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