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

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ClinicalTrials.gov Identifier: NCT04688411
Recruitment Status : Recruiting
First Posted : December 30, 2020
Last Update Posted : February 17, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Sherif Badawy, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Beta Zero Thalassemia Sickle B+ Thalassemia Sickle Cell Hemoglobin C Behavioral: MED-Go App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
Actual Study Start Date : September 28, 2020
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : June 1, 2024


Arm Intervention/treatment
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

No Intervention: Control Arm
Standard of care



Primary Outcome Measures :
  1. Percentage of patients achieving feasibility criteria of using the MED-Go app [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Scores of System Usability Scale (SUS) [ Time Frame: 12 weeks ]
    App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)

  2. Hydroxyurea adherence rates [ Time Frame: 12 weeks ]
    Adherence rate is defined as number of given HU doses as recorded by the app divided by total number of doses during study period.



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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04688411


Contacts
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Contact: Sherif M Badawy, MD, MS (312) 227-4836 sbadawy@luriechildrens.org
Contact: Kathryn King, BS (312) 227-4825 katking@luriechildrens.org

Locations
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United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Sherif M. Badawy, MD, MS    312-227-4836    sbadawy@luriechildrens.org   
Principal Investigator: Sherif M. Badawy, MD, MS         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Sherif M. Badawy, MD, MS Ann & Robert H Lurie Children's Hospital of Chicago
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Responsible Party: Sherif Badawy, MD, Assistant Professor, Department of Pediatrics, Division of Hematology, Oncology and Stem Cell Transplant, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT04688411    
Other Study ID Numbers: IRB 2020-3367
1K23HL150232 ( U.S. NIH Grant/Contract )
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All patient data will be deidentified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sherif Badawy, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
sickle cell disease
hydrxoyurea
mHealth intervention
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Thalassemia
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn