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CompletedNCT05719064ACPSUpdated Jul 10, 2025

Early Prototyping and Usability Testing (ACPS)

An interventional study of Adaptive Cell Phone Support in Medication Adherence, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 15 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
15 Years to 20 Years
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Medication Adherence

Keywords

  • Adolescents
  • Mobile health
  • chronic illness
03

In context

Medication Adherence

223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.

This study's enrollment of 22 is below the median of 118 across 189 interventional studies indexed under Medication Adherence.

Browse Medication Adherence studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • 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 improved medication adherence.

    Behavioral: Adaptive Cell Phone Support

Interventions

  • BehavioralAdaptive Cell Phone Support

    Mobile health adherence promotion based on the supportive accountability model

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 3 weeks

  2. 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.

    Time frame: Baseline to 3 weeks

  3. 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.

    Time frame: Baseline to 3 weeks

07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
08

References and documents

Individual participant data

Plan to share: Yes — De-identified study data and associated documentation will be made available to the research community free of charge through the data repository hosted at Open Science Framework (OSF).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05719064
Lead sponsor
Children's Hospital Los Angeles
Responsible party
Caitlin Sayegh (Principal Investigator, Children's Hospital Los Angeles) — Principal investigator
First posted
Feb 8, 2023
Start date
Jan 26, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
Jul 10, 2025

Study contacts

Caitlin Sayegh, PhD
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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