NCT07084155

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. 1.Is the final version of the intervention sufficiently feasible, usable, and acceptable for evaluation in a randomized clinical trial?
  2. 2.Do participants show improvements in medication adherence during their field testing of the intervention?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

July 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

July 17, 2025

Last Update Submit

May 8, 2026

Conditions

Keywords

adolescentsmobile healthadherence

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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 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 improve medication adherence.

Behavioral: Adaptive Cell Phone Support

Interventions

Mobile health adherence promotion based on the supportive accountability model

Adaptive Cell Phone Support

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children's Hospital Los Angeles patient
  • between 15-20 years old at enrollment
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Caitlin Sayegh, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Sayegh, PhD

CONTACT

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
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 24, 2025

Study Start

March 25, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

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.
Access Criteria
https://dash.nichd.nih.gov/resource/DASHUserAgreement
More information

Locations