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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
Sponsor:
Collaborators:
Mayo Clinic
Northwestern Memorial Hospital
University of Illinois at Chicago
Information provided by (Responsible Party):
Northwestern University

Brief Summary:
The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.

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
Allocation: Randomized
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

Arm Intervention/treatment
No Intervention: Usual Care
Patients in this group will receive the usual standard of care.
Experimental: Intervention
Patients in this group will receive the TAKE IT strategy components.
Behavioral: TAKE IT Strategy

The TAKE IT Strategy includes:

  1. Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
  2. SMS text-messaging to remind patients when to take all their medicine.
  3. A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
  4. EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond.



Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in eGFR (estimated glomurular filtration rate), ml/mm [ Time Frame: 2 years ]
    Change in eGFR rate over 2 years

  4. Re-hospitalization [ Time Frame: 2 years ]
    Acute care hospitalizations post transplant



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) age 18 or older
  • 2) within 3 months of KT (de novo) or 18-36 months post-KT (established)
  • 3) English speaking
  • 4) primarily responsible for administering own medication
  • 5) own a cell phone and comfortable receiving text messages
  • 6) access and proficiency using internet in home.

Exclusion Criteria:

  • any severe, uncorrectable vision, hearing or cognitive impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104868


Contacts
Contact: Michael S Wolf, PhD 312-503-5592 mswolf@northwestern.edu

Locations
United States, Arizona
Mayo Clinic, Arizona Not yet recruiting
Scottsdale, Arizona, United States, 85054
Contact: Sumi Nair    480-342-1010      
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60613
Contact: Amy Moore    312-485-7341    amy.moore@ucdconnect.ie   
Sponsors and Collaborators
Northwestern University
Mayo Clinic
Northwestern Memorial Hospital
University of Illinois at Chicago

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03104868     History of Changes
Other Study ID Numbers: STU00204465
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No