Adaptive Cell Phone Support (ACPS) (ACPS)

Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions

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

-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.

Study Overview

• Status: Not yet recruiting
• Conditions: Medication Adherence
• Intervention / Treatment: Behavioral: Adaptive Cell Phone Support; Behavioral: Computer-Delivered Cell Phone Support; Behavioral: Automated Text Reminders

Detailed Description

Plan to enroll 96 participants in this study, which is a sequential randomized trial.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin Sayegh, PhD; Phone Number: 13233617748; Email: cssayegh@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children Hospital Los Angeles
      • Principal Investigator: Caitlin Sayegh, PhD
      • Contact: Caitlin Sayegh, PhD; Phone Number: 13233617748; Email: cssayegh@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

There is no exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer-Delivered Cell Phone Support; Computer-delivered cell phone support (reminders, problem-solving, referrals to resources)	Behavioral: Computer-Delivered Cell Phone Support; Mobile health adherence promotion based on the supportive accountability model
Active Comparator: Automated Text Reminders; Scheduled one-way text automated message reminders to take medication	Behavioral: Automated Text Reminders; Scheduled text reminder to take medication
Experimental: 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 improve medication adherence.	Behavioral: Adaptive Cell Phone Support; Mobile health adherence promotion based on the supportive accountability model; Behavioral: Computer-Delivered Cell Phone Support; Mobile health adherence promotion based on the supportive accountability model

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean scores on the Mobile Health App Usability Questionnaire	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.	Baseline to 12 weeks
Total scores on the theoretical framework of acceptability questionnaire	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.	Baseline to 12 weeks
Total scores on the Visual Analogue Scale	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.	Baseline to 12 weeks
Total scores on Rollnick's Readiness Ruler	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.	Baseline to 12 weeks
Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire	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.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Caitlin Sayegh, PhD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2030

Study Registration Dates

• First Submitted: July 7, 2025
• First Submitted That Met QC Criteria: July 7, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; chronic illness; Mobile health
• Other Study ID Numbers: CHLA-23-00149_Phase III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will include electronically-administered survey items assessing demographic characteristics, intervention usability, intervention acceptability, medication adherence, motivation for adherence, transition readiness skills, and allocation of treatment responsibility as well as medication regimen complexity data and pharmacy possession refill rates abstracted from the electronic medical chart, and behavioral engagement data collected via the Computerized Intervention Authoring Software.
• IPD Sharing Time Frame: Final submission and release of the study data will occur no later than the time of an associated publication or the end of the performance period, whichever comes first. Study data deposited in DASH will be available to the research community in perpetuity.
• IPD Sharing Access Criteria: https://dash.nichd.nih.gov/resource/DASHUserAgreement

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No