An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
Primary Purpose
Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MED-Go App
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease focused on measuring sickle cell disease, hydrxoyurea, mHealth intervention
Eligibility 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
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of ChicagoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
MED-Go app Intervention
Control Arm
Arm Description
Participants will use MED-Go app intervention for a total of 12 weeks
Standard of care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Scores of System Usability Scale (SUS)
App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)
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.
Full Information
NCT ID
NCT04688411
First Posted
December 24, 2020
Last Updated
September 8, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04688411
Brief Title
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
Official Title
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia, Sickle Cell Hemoglobin C
Keywords
sickle cell disease, hydrxoyurea, mHealth intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MED-Go app Intervention
Arm Type
Other
Arm Description
Participants will use MED-Go app intervention for a total of 12 weeks
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Behavioral
Intervention Name(s)
MED-Go App
Intervention Description
A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
Primary Outcome Measure Information:
Title
Percentage of patients achieving feasibility criteria of using the MED-Go app
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Scores of System Usability Scale (SUS)
Description
App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)
Time Frame
12 weeks
Title
Hydroxyurea adherence rates
Description
Adherence rate is defined as number of given HU doses as recorded by the app divided by total number of doses during study period.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherif M Badawy, MD, MS
Phone
(312) 227-4836
Email
sbadawy@luriechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Savannah Winkler, BS
Phone
(312) 227-4807
Email
swinkler@luriechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif M. Badawy, MD, MS
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherif M. Badawy, MD, MS
Phone
312-227-4836
Email
sbadawy@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Savannah Winkler, BS
Phone
(312) 227-4807
Email
swinkler@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Sherif M. Badawy, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All patient data will be deidentified
Learn more about this trial
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
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