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

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT04688411
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
40
Enrollment
1
Location
2
Arms
44.1
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: MED-Go App
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Sep 28, 2020
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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
No Intervention: Control Arm

Standard of care

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients achieving feasibility criteria of using the MED-Go app [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) [12 weeks]

    App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)

  2. Hydroxyurea adherence rates [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ann & Robert H Lurie Children's Hospital of Chicago Chicago Illinois United States 60611

Sponsors and Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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
First Posted:
Dec 30, 2020
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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
sickle cell disease
hydrxoyurea
mHealth intervention
Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Hemoglobin SC Disease

Study Results

No Results Posted as of Mar 8, 2022