Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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).
Not provided
Not provided
Not provided
Not provided
| 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 improved 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 |
|---|---|---|
| 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 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
There is no exclusion criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Los Angeles | California | 90027 | United States |
De-identified study data and associated documentation will be made available to the research community free of charge through the data repository hosted at Open Science Framework (OSF).
Not provided
Final submission and release of the study data will occur within 12 months of the conclusion of data collection, and within the award period. Study data deposited in OSF will be available to the research community in perpetuity.
Any OSF users can access the de-identified data.
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 8, 2026 | |
| Reset | Jun 3, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 8, 2026 | Jun 3, 2026 |
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |