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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.
Plan to enroll 96 participants in this study, which is a sequential randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Cell Phone Support | Experimental | 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. |
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| Computer-Delivered Cell Phone Support | Experimental | Computer-delivered cell phone support (reminders, problem-solving, referrals to resources) |
|
| Automated Text Reminders | Active Comparator | Scheduled one-way text automated message reminders to take medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Cell Phone Support | Behavioral | Mobile health adherence promotion based on the supportive accountability model |
|
| 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. | Baseline to 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. | Baseline to 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. | Baseline to 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. | Baseline to 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. | Baseline to 12 weeks |
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Inclusion Criteria:
There is no exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Sayegh, PhD | Contact | 13233617748 | cssayegh@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Caitlin Sayegh, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital Los Angeles | Los Angeles | California | 90027 | United States |
The data will include electronically-administered survey items assessing demographic characteristics, intervention usability, intervention acceptability, medication adherence, motivation for adherence, transition readiness skills, and allocation of treatment responsibility as well as medication regimen complexity data and pharmacy possession refill rates abstracted from the electronic medical chart, and behavioral engagement data collected via the Computerized Intervention Authoring Software.
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Final submission and release of the study data will occur no later than the time of an associated publication or the end of the performance period, whichever comes first. Study data deposited in DASH will be available to the research community in perpetuity.
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Computer-Delivered Cell Phone Support | Behavioral | Mobile health adherence promotion based on the supportive accountability model |
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| Automated Text Reminders | Behavioral | Scheduled text reminder to take medication |
|
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |