| Primary | Enrollment Rate | Percent of approached eligible participants enrolling in the study | | Posted | | Count of Participants | | Participants | | End of study enrollment period, approximately 12 months after enrollment initiation | | | | ID | Title | Description |
|---|
| OG000 | Overall | Enrollment and retention were calculated at the study level |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Retention Rate | The percent of participants completing all procedures for which they were eligible The numerator is calculated via the following formula: (n AYAs eligible to complete at least some study procedures [n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start] - n AYAs who never started study procedures - n AYAs who did not complete at least some study procedures) The denominator (n AYAs eligible to complete at least some study procedures) is calculated via the following formula: (n enrolled AYAs - n AYAs meeting criteria for unenrollment prior to study start) | In all, 65 AYAs were eligible to complete at least some study procedures (70 enrolled - 5 meeting criteria for unenrollment prior to start = 65). Of these, 56 (65 - 8 AYAs who never started - 1 AYA who did not complete at least some study procedures = 56) completed all study procedures for which they were eligible, resulting in a retention rate of 86% (56/65). | Posted | | Count of Participants | | Participants | | From enrollment to study completion (approximately 4 weeks for patients deemed ineligible after run-in and approximately 16 weeks for patients deemed eligible after run-in) | | | | ID | Title | Description |
|---|
| OG000 | Overall | Enrollment and retention were calculated at the study level |
| |
| Secondary | Intervention Fidelity: Contact | Percent of participants randomized to the Tailored Program who completed 4 intervention sessions | This outcome is relevant to the Tailored Program only. Data from 2 participants who met criteria for unenrollment during the Tailored Program, and thus received fewer than 4 sessions due to no longer being eligible, are not included | Posted | | Count of Participants | | Participants | | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
|
| Secondary | Intervention Fidelity: Length | Percent of participants randomized to the Tailored Program for whom all sessions were 30-45 minutes in length | This outcome is relevant to the Tailored Program only. | Posted | | Count of Participants | | Participants | | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
| |
| Secondary | Intervention Fidelity: Duration | Percent of randomized to the Tailored Program who completed all 4 intervention sessions during a 8-10 week period | This outcome is relevant to the Tailored Program only. Data from 2 participants who met criteria for unenrollment during the Tailored Program, and thus received fewer than 4 sessions due to no longer being eligible, are not included | Posted | | Count of Participants | | Participants | | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
|
| Secondary | Intervention Fidelity: Content | Percent of participants randomized to the Tailored Program who received all of the planned intervention content as defined in the fidelity checklist | This outcome is relevant to participants randomized to the tailored program only | Posted | | Count of Participants | | Participants | | From randomization to the Tailored Program (at approximately week 4) to the completion of the Tailored Program (at approximately week 12) (total duration = approximately 8 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
|
| Secondary | Assessment Completion | Percent of enrolled participants with complete data | | Posted | | Count of Participants | | Participants | | From enrollment to the completion of post-intervention assessment which occurred approximately 4 weeks after program completion (total time frame = approximately 16 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
| |
| Secondary | System Usability Scale | A 10-item rating of usability, range = 0-100, better scores indicate better usability | | Posted | | Mean | Standard Deviation | score on a scale | | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
| |
| Secondary | "Adjective Rating Scale" (Measure of Usability) | 1-item rating of user friendliness, range = 1 (worst imaginable) to 7 (best imaginable), higher scores indicate better usability | | Posted | | Mean | Standard Deviation | score on a scale | | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
| |
| Secondary | Number of Participants Rating Behavioral Treatment Acceptability as 4 or Greater | Rating of behavioral treatment acceptability - "I would recommend this program to other adolescents and young adults"; Possible range = 1 (strongly disagree) - 5 (strongly agree), better scores represent better acceptability; Dichotomous variable created representing whether participants scored this item as 1-3 (not acceptable) or 4-5 (acceptable) | | Posted | | Count of Participants | | Participants | | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
|
| Secondary | Medical Adherence Measure | 1-item self-report of missed doses | | Posted | | Mean | Standard Deviation | percentage of doses taken | | Post-intervention assessment, approximately 4 weeks after program completion and approximately 16 weeks after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
| |
| Secondary | Electronically Monitored Medication Adherence | Each participant will be given an electronic monitoring device to store their medication. The electronic monitoring device records each time the device is opened. | Two participants had their medication discontinued prior to the end of the study period and thus do not have electronic adherence monitoring device data | Posted | | Mean | Standard Deviation | percentage of doses taken | | Starting 4 weeks prior to treatment initiation (approximately weeks 1-4) and continuing until 4 weeks after program completion (approximately weeks 12-16) | | | | ID | Title | Description |
|---|
| OG000 | Tailored Program | 8-week tailored program including 4 coach visits and 4 bi-weekly text check-ins Tailored Program: Participants in the tailored program will participate in 4 sessions with a coach, 1 every other week. During these sessions, the AYA will work with their coach to identify a barrier to adherence to target and create an action plan using evidence-based behavior change techniques to address this barrier. In between sessions (on alternating weeks), the coach will check-in with a text including a reminder about the action plan and a calendar of the AYA's eCAP adherence data. | | OG001 | Feedback Program | 8-week feedback program including 8 weekly texts Feedback Program: Participants in the Feedback Program will receive weekly text messages including: a calendar depicting their weekly adherence (per eCAP data) and guidance for requesting additional support as desired. |
|