Adaptive Cell Phone Support to Promote Medication Adherence

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Medication Adherence

Intervention / Treatment
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* Behavioral: Adaptive Cell Phone Support
* Behavioral: Computer-Delivered Cell Phone Support
* Behavioral: Automated Text Reminders


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptive Cell Phone Support<br>Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) and responsive human coaching (phone calls, test messages, in-app messaging) to improved medication adherence. | Behavioral: Adaptive Cell Phone Support<br>* Mobile health adherence promotion based on the supportive accountability model<br>Behavioral: Computer-Delivered Cell Phone Support<br>* Mobile health adherence promotion based on the supportive accountability model<br>|
| Experimental: Computer-Delivered Cell Phone Support<br>Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) | Behavioral: Computer-Delivered Cell Phone Support<br>* Mobile health adherence promotion based on the supportive accountability model<br>|
| Active Comparator: Automated Text Reminders<br>Scheduled one-way text automated message reminders to take medication | Behavioral: Automated Text Reminders<br>* Scheduled text reminder to take medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |