Adaptive Cell Phone Support to Promote Medication Adherence

Not Applicable

Recruiting

• Conditions: Medication Adherence
• Interventions: Behavioral: Adaptive Cell Phone Support; Behavioral: Automated Text Reminders; Behavioral: Computer-Delivered Cell Phone Support

• Registration Number: NCT05719064
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

The goal of this pilot clinical trial is to refine and test a mobile health intervention for promoting medication adherence in a population of adolescents and young adults with chronic health conditions. The main question\[s\] it aims to answer are:

* How should the intervention be designed to best fit patients' needs and preferences?

* Is an adaptive intervention (personalizing the intensity of support based on patients' needs) efficacious for promoting medication adherence Researchers will compare the adaptive intervention to automated text message reminders see if the adaptive intervention shows stronger positive effects on medication adherence.

Detailed Description

An initial cohort of adolescents with chronic health conditions will be asked to try the intervention and give feedback to refine the structure and content. Then, a larger cohort will progress through a sequential multiple assignment randomized trial to 1) be randomized to either automated text reminders (active control condition) or computer-delivered Cell Phone Support and then 2) those in the computer-delivered Cell Phone Support condition who do not show a sufficient response will be re-assigned to continued computer-delivered Cell Phone Support only or to Adaptive Cell Phone Support ( computer-delivered Cell Phone Support + responsive human coaching).

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Study Start: 2024-01-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Children's Hospital Los Angeles patient
• between 15-20 years old
• taking at least one oral medication per day for a chronic health condition
• English speaking
• demonstrating sufficient cognitive capacity to engage in the assent/consent process and study procedures
• has a cell phone

There is no exclusion criteria.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Adaptive Cell Phone Support	Adaptive Cell Phone Support	Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) and responsive human coaching (phone calls, test messages, in-app messaging) to improved medication adherence.
Adaptive Cell Phone Support	Computer-Delivered Cell Phone Support	Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) and responsive human coaching (phone calls, test messages, in-app messaging) to improved medication adherence.
Computer-Delivered Cell Phone Support	Computer-Delivered Cell Phone Support	Computer-delivered cell phone support (reminders, problem-solving, referrals to resources)
Automated Text Reminders	Automated Text Reminders	Scheduled one-way text automated message reminders to take medication

Primary Outcome Measures

Name	Time	Method
Mean scores on the Mobile Health App Usability Questionnaire	12 weeks	Higher scores indicate greater ease with which users can use technology to achieve a particular goal; the minimum value of this questionnaire is 1 and the maximum value is 7.
Total scores on the Visual Analogue Scale	12 weeks	Percentage of doses taken our of 100%; higher numbers indicate greater medication adherence. This scale presents participants with a line, marked 0 on the left and 100 on the right, and participants can drag a marker to the place on the line that best visually indicated their adherence.
Total scores on the theoretical framework of acceptability questionnaire	12 weeks	Higher scores indicate a greater "extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention"; the minimum value of this questionnaire is 7 and the maximum value is 35.
Total scores on Rollnick's Readiness Ruler	12 weeks	Higher scores on this measure indicate more motivation to take medication as prescribed; the minimum value of this questionnaire is 0 and the maximum value is 10.
Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire	12 weeks	Higher scores on extent to which patients are prepared to manage their health condition as adults, outside of the pediatric system; ; the minimum value of this questionnaire is 0 and the maximum value is 90.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States