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

NCT ID: NCT04288271

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2023-06-30

Brief Summary

Medication non-adherence is a major problem in kidney transplant recipients; young people 12-24 years of age are at particularly high risk for non-adherence and graft failure compared to young children and adults. Given that poor medication contributes greatly to graft failure, clinically feasible and effective interventions are urgently needed to improve adherence, survival, and quality of life in this population. The broad aim of this prospective, 3-stage, sequential study is to improve medication adherence in adolescent kidney transplant recipients by: 1) adapting the successful Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention for use in 'real world' clinical care, 2) designing and testing a new portable electronic pillbox and companion tracking website interface, and 3) preliminary testing of the adapted intervention.

Detailed 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 intervention for real-world use.

Stage 3 aims to pilot the adapted intervention, including the new e-pillbox, in a CRT to:

1. Determine the feasibility of a full-scale CRT (process considerations, attrition)

2. 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

3. 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.). Parents of eligible patients <18y old who have agreed to participate in the study will also be eligible to participate (57 parents anticipated). We will also enroll 2-3 HCPs, most involved with direct patient care, at each adherence intervention site to allow capture of information on their experience with the e-pillbox system and intervention over the course of the study (9 HCPs anticipated). No HCP will be enrolled at healthy living intervention sites. Participants will be blinded to group allocation but, given the nature of the intervention, coaches must be aware of group allocation.

Patients participants: 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. The healthcare team will provide the usual level of care to all participants. 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.

Parent participants: Parents of patient participants under 18 will be invited to participate in the study and accompany their child to study visits. Participating parents will be present at the beginning of the baseline visit to help their child provide demographic information. The parent will return at the end of the baseline visit, to learn how to use the e-pillbox (along with their child), to watch the educational videos and to respond to the PMBS and C-ATR. Parent participants will respond to the PMBS and C-ATR once more at week 14. Participating parents at adherence intervention sites will be present in the formation of the patient's action plan and choose their own action plan to support their child's adherence or independence. Parental participation throughout the study is encouraged but not mandatory.

HCP Participants: 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 adherence intervention sites will be advised that they will be informed by study staff about adherence events among participants in the interval between 4 and 14 weeks. When coaches review each participant's adherence on the portal during study visits, they will discuss non-adherence events with patients to determine if these were related to technical issues or real adherence issues. Within 1 week of study visits, the coach will provide the HCP with a copy of the patient's adherence calendar with a note as to whether the events seem to reflect real non-adherence. HCP will be advised that they will be under no obligation to act on this information, but may if they wish; if the participating HCP receiving information about a patient is not that patient's primary transplant care provider, they will be asked to transmit the information to the appropriate HCP on the patient's care team. Study staff will be provided with a suggested algorithm to follow if they receive such an alert.Within 2 weeks after the last patient at the site completes the 14-week visit at adherence intervention sites, HCP participants will complete questionnaires on their experience using the adherence-tracking web portal.

Conditions

Medication Adherence; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Adherence Intervention

The objective of the intervention is to improve medication adherence. Patient-participants will use a multi-dose electronic pillbox and adherence tracking website which can provide dose reminders. Patient will form an Adherence Support Team (AST) including the participant, a parent (or other) and the "Coach" (study coordinator). The Coach will guide the AST to use Action-focused Problem-solving to address personal barriers to adherence. They will then generate concrete "if-then" plans for how they will behave in a given situation. Intervention participants with excellent adherence will be encouraged to work on building autonomy in medication-taking instead of adherence. Action plans will be able to be modified, if desired, at the 6-week and 10-week check-ins.

HCP-participants at intervention sites will be given the option to login to the adherence tracking website to view the adherence data of their patients. They will also be alerted by study staff to critical non-adherence events.

Group Type: EXPERIMENTAL

Adherence Intervention

Intervention Type: BEHAVIORAL

Intervention:

• Adherence Support Team (patient, parent or a significant other, Coach)
• Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
• Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility
• 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient

Device:

• Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website
• Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week.

Healthy Living Education Intervention

Patient-participants will receive a healthy living education intervention with the use of an e-pillbox. Contacts with the coach will occur at the same intervals as at adherence intervention sites. Participants will choose one of 3 healthy living topics on which they will receive education in an interactive format. The coach will engage the participant in a semi-scripted conversation on the selected topic. At check-ins, the coach will either continue the conversation on the topic selected at the outset or provide education on another topic. The coach will NOT engage in discussions about adherence and will NOT provide feedback on adherence data.

Group Type: OTHER

Healthy living education intervention

Intervention Type: OTHER

Intervention:

• Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
• Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits
• 'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient

Device:

• Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w)

Interventions

Adherence Intervention

Intervention:

• Adherence Support Team (patient, parent or a significant other, Coach)
• Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
• Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility
• 'Action-Focused Problem-Solving' to address barriers selected as most important by the patient

Device:

• Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website
• Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week.

Intervention Type: BEHAVIORAL

Healthy living education intervention

Intervention:

• Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
• Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits
• 'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient

Device:

• Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w)

Intervention Type: OTHER

Other Intervention Names

Action-focused problem-solving; Electronic multi-dose pillbox monitoring system; Medy Box; Portable e-pillbox

Eligibility Criteria

Inclusion Criteria

• kidney-only transplant recipients, who are ≥3 months post-transplant
• Aged 12 to 24 years
• Patients followed at one of the study sites

• Representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center.
• HCP from adherence intervention sites

Exclusion Criteria

• Patients with significant neurocognitive disabilities limiting their ability to understand and participate in their own care (as judged by the parents and the healthcare team)
• Patients unable to communicate in English or French (Montreal sites only)
• Multi-organ transplant recipients
• Patient has a sibling participating in Stage 3
• Patients with no internet access

• Parents of patients 18-24 years old will be excluded as the older aged group is expected to be primarily responsible for their own care, independent of their parents. One parent per family will be eligible to avoid redundant representation.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Bethany Foster

Chair of the Department of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bethany J Foster, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Montreal Children's Hospital of the MUHC

Annette DeVito Dabbs, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Locations

St-Louis Children's Hospital

St Louis, Missouri, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

BC Children's Hospital

Vancouver, British Columbia, Canada

University of Toronto Hospital for Sick Children

Toronto, Ontario, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

CHU Ste-Justine

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

5R01DK110737

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MP-CUSM-15-598

Identifier Type: -

Identifier Source: org_study_id