NCT02910661

Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

TAKE-IT TOO: Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 95 (actual)
• Sponsor: Beth Foster · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.

Detailed description

TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus groups (FG) to gather data about the needs and preferences of stakeholders to inform adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The protocols for Stages 2 and 3 will be submitted separately.

Conditions

• Medication Adherence

Interventions

Type	Name	Description
OTHER	Focus Group	Concurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last \~90 min. and be audio-recorded. An observer will take field notes.

Timeline

• Start date: 2017-03-28
• Primary completion: 2017-08-06
• Completion: 2017-08-06
• First posted: 2016-09-22
• Last updated: 2017-09-28

Locations

9 sites across 2 countries: United States, Canada