Adaptive Cell Phone Support to Promote Medication Adherence Among Adolescents and Young Adults With Chronic Health Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Total scores on the theoretical framework of acceptability questionnaire
Study Overview
Brief Summary
The goal of this feasibility pilot trial is to finalize the design of 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:
- Is the final version of the intervention sufficiently feasible, usable, and acceptable for evaluation in a randomized clinical trial?
- Do participants show improvements in medication adherence during their field testing of the intervention?
Detailed Description
Adolescents with chronic health conditions will be asked to try the intervention for three weeks and give feedback to refine the structure and content in preparation for a future randomized trial of the finalized version of the intervention. Plan to enroll 35 participants in this single arm feasibility/usability trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- 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 at enrollment
- •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)
Outcomes
Primary Outcomes
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.
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 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Caitlin Sayegh
Assistant Professor of Clinical Pediatrics
Children's Hospital Los Angeles