Adaptive Cell Phone Support to Promote Medication Adherence

Medication Adherence Clinical Trial

— ACPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719064
• Other study ID #: CHLA-23-00149
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital Los Angeles
• Contact: Caitlin S Sayegh, PhD
• Phone: 13233617748
• Email: cssayegh[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Adaptive Cell Phone Support
Mobile health adherence promotion based on the supportive accountability model
• Computer-Delivered Cell Phone Support
Mobile health adherence promotion based on the supportive accountability model
• Automated Text Reminders
Scheduled text reminder to take medication

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks