Final Prototype Refinement of Adaptive Cell Phone Support

Not Applicable

Not yet recruiting

• Conditions: Medication Adherence

• Registration Number: NCT07084155
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

The goal of this feasibility pilot trial is to finalize the design of 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:

1. Is the final version of the intervention sufficiently feasible, usable, and acceptable for evaluation in a randomized clinical trial?

2. Do participants show improvements in medication adherence during their field testing of the intervention?

Detailed Description

Adolescents with chronic health conditions will be asked to try the intervention for three weeks and give feedback to refine the structure and content in preparation for a future randomized trial of the finalized version of the intervention. Plan to enroll 35 participants in this single arm feasbility/usability trial.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2026-02-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Total scores on the theoretical framework of acceptability questionnaire	Baseline to 3 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.
Mean scores on the Mobile Health App Usability Questionnaire	Baseline to 3 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	Baseline to 3 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.