Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Mean scores on the Mobile Health App Usability Questionnaire
Study Overview
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.
Detailed Description
Plan to enroll 96 participants in this study, which is a sequential randomized trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •There is no
Exclusion Criteria
- Not provided
Arms & Interventions
Adaptive Cell Phone Support
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.
Intervention: Adaptive Cell Phone Support (Behavioral)
Adaptive Cell Phone Support
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.
Intervention: Computer-Delivered Cell Phone Support (Behavioral)
Computer-Delivered Cell Phone Support
Computer-delivered cell phone support (reminders, problem-solving, referrals to resources)
Intervention: Computer-Delivered Cell Phone Support (Behavioral)
Automated Text Reminders
Scheduled one-way text automated message reminders to take medication
Intervention: Automated Text Reminders (Behavioral)
Outcomes
Primary Outcomes
Mean scores on the Mobile Health App Usability Questionnaire
Time Frame: Baseline to 12 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 12 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 12 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.
Total scores on Rollnick's Readiness Ruler
Time Frame: Baseline to 12 weeks
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.
Total Transition Readiness scores on the Successful Transition to Adulthood with Therapeutic = Rx Questionnaire
Time Frame: Baseline to 12 weeks
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Caitlin Sayegh
Assistant Professor of Clinical Pediatrics
Children's Hospital Los Angeles