TAKE-IT TOO: Teen Adherence in KidnEy Transplant Improving Tracking To Optimize Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 16
- 主要终点
- Taking Adherence
研究概览
简要总结
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.
详细描述
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.). 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants (patient-, parent- and HCP-participants) will be blinded to group allocation but, given the nature of the intervention, study coordinators who will be acting as coaches must be aware of group allocation.
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 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
排除标准
- •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 Inclusion Criteria • Parent of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center) will be eligible
- •Parents Exclusion Criteria
- •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.
- •Health Care Professionals Inclusion Criteria
- •Representatives from the variety of disciplines typically involved in promoting medication adherence as deemed appropriate from each center.
- •HCP from adherence intervention sites
研究组 & 干预措施
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.
干预措施: Adherence Intervention (Behavioral)
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.
干预措施: Healthy living education intervention (Other)
结局指标
主要结局
Taking Adherence
时间窗: 14 weeks
percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize adherence for each arm, the total percentage of days of observation for which there was 100% taking adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which taking adherence was 100% summed across all participants.
Timing Adherence
时间窗: 14 weeks
percentage of doses taken within 2 hours before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice-daily dosing, and 0% or 100% for patients on once-daily dosing. Each patient will have a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use, no score will be given. To summarize timing adherence for each arm, the total percentage of days of observation for which there is 100% timing adherence will be calculated. The denominator for this calculation will be the total number of days of observation of each participant summed across all participants; the numerator will be the total number of days of observation of each participant for which timing adherence is 100% summed across all participants.
次要结局
- Self-reported Timing Adherence(14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits))
- Self-reported Taking Adherence(14 weeks (at baseline, 4-week, 6-week, 10-weeks, 14-week visits))
研究者
Bethany Foster
Chair of the Department of Pediatrics
McGill University Health Centre/Research Institute of the McGill University Health Centre