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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:
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.
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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. |
|
| 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 |
|---|---|---|
| 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 3 weeks |
| 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 3 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 3 weeks |
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Inclusion Criteria:
There is no exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin Sayegh, PhD | Contact | 323-361-7748 | 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's Hospital Los Angeles | Recruiting | 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 |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| D001519 | Behavior |