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Clinical Trials/NCT05719064
NCT05719064
Completed
N/A

Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions

Children's Hospital Los Angeles1 site in 1 country22 target enrollmentJanuary 26, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Children's Hospital Los Angeles
Enrollment
22
Locations
1
Primary Endpoint
Mean scores on the Mobile Health App Usability Questionnaire
Status
Completed
Last Updated
9 months ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
January 26, 2024
End Date
February 20, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caitlin Sayegh

Principal Investigator

Children's Hospital Los Angeles

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mean scores on the Mobile Health App Usability Questionnaire

Time Frame: 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 theoretical framework of acceptability questionnaire

Time Frame: 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.

Total scores on the Visual Analogue Scale

Time Frame: 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.

Study Sites (1)

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