Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
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|ClinicalTrials.gov Identifier: NCT03104868|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : May 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant||Behavioral: TAKE IT Strategy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized to one of two arms: TAKE IT strategy or usual care.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||We will blind: 1) research interviewers involved with outcomes assessment, 2) personnel involved in statistical analyses (Dr. Kwasny, Ms. Patel), 3) principal investigators (Wolf, Ladner). Site project managers will have access to study arm assignments to initiate TAKE IT components to those randomized to receive them.|
|Primary Purpose:||Supportive Care|
|Official Title:||Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial|
|Actual Study Start Date :||May 3, 2018|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||April 2022|
No Intervention: Usual Care
Patients in this group will receive the usual standard of care.
Patients in this group will receive the TAKE IT strategy components.
Behavioral: TAKE IT Strategy
The TAKE IT Strategy includes:
- Rx in-person pill count [ Time Frame: 2 years ]An in-person pill count using established guidelines will be conducted. Adherence will be assessed within drugs. The proportion of pills taken/pills prescribed will be calculated per medication. Patients will be considered non-adherent for a medication if this score is >=80%.
- 24 hour recall [ Time Frame: 2 years ]Patient self-report of how many pills and how often each medicine was taken over the last 24 hours. Correct dosing will be measured as yes/no per drug, having properly shown dose (# pills), spacing (hours between doses), frequency (times per day), and total pills/day.
- Ask-12 [ Time Frame: 2 years ]The Ask-12 is a self-report scale that assesses general medication attitudes and beliefs. The scale consists of 12 items across three domains (inconvenience/forgetfulness, treatment beliefs, and behaviors), with responses ranging from "Strongly Disagree" to "Strongly Agree". Score can range from 12-60 with higher scores representing greater barriers to adherence.
- Change in eGFR (estimated glomurular filtration rate), ml/mm [ Time Frame: 2 years ]Change in eGFR rate over 2 years
- Re-hospitalization [ Time Frame: 2 years ]Acute care hospitalizations post transplant
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104868
|Contact: Michael S Wolf, PhDfirstname.lastname@example.org|
|United States, Arizona|
|Mayo Clinic, Arizona||Not yet recruiting|
|Scottsdale, Arizona, United States, 85054|
|Contact: Sumi Nair 480-342-1010|
|United States, Illinois|
|Chicago, Illinois, United States, 60613|
|Contact: Amy Moore 312-485-7341 email@example.com|