NCT07064824

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
36mo left

Started Aug 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

July 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2030

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 7, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

AdolescentsMobile healthchronic illness

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (3)

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 SupportBehavioral: Computer-Delivered Cell Phone Support

Computer-Delivered Cell Phone Support

EXPERIMENTAL

Computer-delivered cell phone support (reminders, problem-solving, referrals to resources)

Behavioral: Computer-Delivered Cell Phone Support

Automated Text Reminders

ACTIVE COMPARATOR

Scheduled one-way text automated message reminders to take medication

Behavioral: Automated Text Reminders

Interventions

Mobile health adherence promotion based on the supportive accountability model

Adaptive Cell Phone Support

Mobile health adherence promotion based on the supportive accountability model

Adaptive Cell Phone SupportComputer-Delivered Cell Phone Support

Scheduled text reminder to take medication

Automated Text Reminders

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
  • 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 Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Medication AdherenceChronic Disease

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 15, 2025

Study Start (Estimated)

August 1, 2027

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 30, 2030

Last Updated

July 30, 2025

Record last verified: 2025-07

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