Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes - Stage 3

Summary

Participation Requirements

Description

This entry describes Stage 3 of the study. In Stage 3, the adapted intervention and new e-pillbox and adherence-tracking website will be piloted in preparation for a definitive cluster-randomized trial (CRT). This study builds on the lessons from TAKE-IT and is a critical step towards a scalable int...

This entry describes Stage 3 of the study. In Stage 3, the adapted intervention and new e-pillbox and adherence-tracking website will be piloted in preparation for a definitive cluster-randomized trial (CRT). This study builds on the lessons from TAKE-IT and is a critical step towards a scalable intervention for real-world use. Stage 3 aims to pilot the adapted intervention, including the new e-pillbox, in a CRT to: Determine the feasibility of a full-scale CRT (process considerations, attrition) Understand all stakeholders' experience with the intervention, including the degree to which the e-pillbox and adherence-tracking website are integrated into daily life by patients and into practice by HCP Estimate intra-cluster correlation coefficients (ICC) and other statistical parameters related to adherence outcomes relevant for sample size planning for a CRT. Adherence outcomes to be considered include daily proportion of patients with 100% taking adherence (defined as having taken all prescribed doses in a day) and daily proportion of patients with correct dosing (defined as having taken all prescribed doses within 2 hours before or after the scheduled time). The adapted adherence-promoting intervention will be compared with another intervention in a pilot parallel-groups CRT. The interventions will be applied over 10 weeks. Participating centers, rather than patients, were randomized using a restricted randomization strategy with the Montreal Children's Hospital (MCH) assigned to the adherence intervention. This is necessary to ensure that the PI and lead site get sufficient experience with the intervention to guide other sites and to prepare for the full-scale CRT. All other sites were randomized, stratified on center size, to the new adherence intervention or the healthy living education intervention (control arm); this ensured adequate numbers of participants in each arm. The aim is to enroll 67 patients across all sites over a 6-month interval. Based on numbers of available patients at each site, the targets noted above represent 13-50% of eligible patients at a given site. Allowing for 10% drop-out, 60 will complete the study (TAKE-IT had 4% drop-out by 6 mo.). HCP at each site will also be enrolled (the 2-3 HCP most involved with direct patient care) to allow capture of information on their experience with the e-pillbox system and intervention over the course of the study. Participants will be blinded to group allocation but, given the nature of the intervention, coaches must be aware of group allocation. Enrollment will be followed by a 4-week run-in period during which adherence will be monitored electronically, but no intervention will be applied. This will give participants time to become familiar with the e-pillbox and provide pre-intervention adherence data. All participants will receive a text message from study staff 1 week after initiation of the run-in to check-in on how they are doing with the e-pillbox. If a participant is experiencing difficulties, staff will offer assistance by phone. The first intervention will occur at 4 weeks (+/- 1 wk.). At this visit, participants will meet via video conferencing (or in person, if possible) with the coach. Participants at adherence intervention sites will begin the adherence-promoting intervention, including activation of dose reminders from the e-pillbox (as desired) and access to the adherence-tracking website. Participants at healthy living education intervention sites will begin the healthy living intervention, but will have no dose reminders from the e-pillbox and will not have access to the adherence-tracking website during the intervention interval. The healthcare team will provide the usual level of care to all participants. At the end of the 10-week intervention interval, participants at healthy living education sites will be offered extended use of the e-pillbox, with dose reminders enabled, and access for themselves and their HCP to the adherence-tracking website for an additional 8 weeks. This will serve to encourage participation and use of the e-pillbox at healthy living education sites, and will allow estimation of the degree to which the adherence-tracking website is integrated into practice by HCP without support from a coach, as well as providing a sense of the impact of usual care plus dose reminders and possible feedback from HCP on adherence. This period of extended use will also allow patients at healthy living intervention sites the opportunity to benefit from the e-pillbox component of the intervention, and to be able to express their opinions about all the functionalities of the e-pillbox. Participants will have virtual (or phone) contact with coaches at increasing intervals between initiation of the intervention at week 4 and exit at week 14. The first check-in will occur at week 6 (+/- 1 wk), 2 weeks after initiation of the adherence-promoting intervention, the second will occur at week 10 (+/- 1 wk). This will allow intervals of increasing frequency between contacts as participants become more comfortable with procedures. HCP participants at adherence intervention sites will be trained to use the adherence-tracking website within 2 weeks before to 1 week after the first patient at their site completes the 4-week visit. HCP participants will be given access to the adherence data of all patient participants at their coaching site and invited to consult the website as often as they wish. HCP participants will also be shown a short (5 min) video providing education on assessing and supporting adherence. HCP participants at healthy living education sites will be trained to use the adherence-tracking website within 2 weeks before to 1 week after the first patient at their site completes the 14-week visit. HCP participants will be given access to the adherence data of all patient participants at their healthy living education site and invited to consult the website as often as they wish. HCP participants at all sites will be advised that they will be informed by study staff about critical non-adherence events among participants. At adherence intervention sites, alerts regarding critical non-adherence events will be activated during the interval between 4 and 14 weeks; at healthy living education sites, alerts will be activated during the interval between 14 and 22 weeks. Alerts will be sent to study staff, who will then follow-up with the patient and advise the HCP of the particular issue. HCP will be advised that they will be under no obligation to act on the information in alerts, but may if they wish. Within 2 weeks after the last patient at the site completes the 14-week visit at adherence intervention sites and within 2 weeks after the last patient at the site completes the 22-week visit at healthy living education sites, HCP participants will complete questionnaires on their experience using the fully-functional e-pillbox (including the Post-Study System Usability Questionnaire (PSSUQ) focused on the adherence-tracking website).

Tracking Information