An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
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| ClinicalTrials.gov Identifier: NCT04688411 |
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Recruitment Status :
Recruiting
First Posted : December 30, 2020
Last Update Posted : March 8, 2022
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Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
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
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sickle cell disease
| Arm | Intervention/treatment |
|---|---|
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MED-Go app Intervention
Participants will use MED-Go app intervention for a total of 12 weeks
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Behavioral: MED-Go App
A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease |
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No Intervention: Control Arm
Standard of care
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Primary Outcome Measures :
- 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 :
- 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)
- 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.
Information from the National Library of Medicine
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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
| Contact: Sherif M Badawy, MD, MS | (312) 227-4836 | sbadawy@luriechildrens.org | |
| Contact: Kathryn King, BS | (312) 227-4825 | katking@luriechildrens.org |
Locations
| 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
| Principal Investigator: | Sherif M. Badawy, MD, MS | Ann & Robert H Lurie Children's Hospital of Chicago |
| 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: | March 8, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | All patient data will be deidentified |
| 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:
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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 |