Early Prototyping and Usability Testing (ACPS)

NCT05719064 | Completed

• 1 other identifier: CHLA-23-00149_Phase I
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Adherence

Keywords

Adolescents; Mobile health; chronic illness

Outcome Measures

Primary Outcomes (3)

• 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 3 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 3 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 3 weeks

Study Arms (1)

Adaptive Cell Phone Support

EXPERIMENTAL

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

Adaptive Cell Phone Support BEHAVIORAL

Mobile health adherence promotion based on the supportive accountability model

Adaptive Cell Phone Support

Eligibility Criteria

• Age: 15 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Medication Adherence; Chronic Disease

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caitlin Sayegh, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: January 26, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final submission and release of the study data will occur within 12 months of the conclusion of data collection, and within the award period. Study data deposited in OSF will be available to the research community in perpetuity.
• Access Criteria: Any OSF users can access the de-identified data.

Locations

US (1)