A Randomized Controlled Trial of Mobile Technology-assisted Outpatient Maintenance Therapy in Children With Acute Lymphoblastic Leukaemia (ALL)
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Percentage of time wherein white blood cell concentration is within the target range
Overview
Brief Summary
To assess the efficacy of using mobile technology to improve the percentage of time wherein drug dosing is within the target range
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1\) \< 16 years old at diagnosis;
- •2\) having demonstrated ≥ 3 months of \> 90% compliance with using a mobile app to log in records of daily medication and weekly blood test results;
- •3\) patient or legal guardian provides informed consent
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention group
A mobile application classifies each subject's maintenance therapy dosing status as 'On Track', 'Orange Alert', or 'Red Alert' based on analysis of his/her electronic diary of medication and blood tests.
Intervention: Health monitoring & reminders for a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment. (Behavioral)
Control group
No intervention
Outcomes
Primary Outcomes
Percentage of time wherein white blood cell concentration is within the target range
Time Frame: After randomization
Percentage of time wherein white blood cell concentration is within the target range 2.0 - 3.0 × 10\^9/L after randomization.
Secondary Outcomes
- Percentage of time wherein white blood cell concentration is < 1.0 or > 5.0 × 10^9/L(After randomization)