Using Mobile Technology-assisted Outpatient Maintenance Therapy Pediatric ALL

NCT ID: NCT07278882

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-11-20

Brief Summary

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To assess the efficacy of using mobile technology to improve the percentage of time wherein drug dosing is within the target range

Detailed Description

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Conditions

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Pediatric Acute Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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.

Intervention Type BEHAVIORAL

Subjects classified as 'Orange Alert' receive mobile-phone alert messages that instruct them to self-adjust dose of oral medication. Subjects classified as 'Red Alert' are directed to a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Subjects classified as 'Orange Alert' receive mobile-phone alert messages that instruct them to self-adjust dose of oral medication. Subjects classified as 'Red Alert' are directed to a mobile-phone portal for scheduling a telemedicine clinic visit and receive periodic model-phone messages instructing follow-up blood testing and dose adjustment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* None
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yahui Feng

Role: CONTACT

022-23909051

Facility Contacts

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Yahui Feng

Role: primary

022-23608045

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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IIT2024105

Identifier Type: -

Identifier Source: org_study_id

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