Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial

NCT03104868 | Completed Results DMC

• 1 other identifier: STU00204465
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• Rx Pill Count

  An in-person pill count using established guidelines will be conducted. When in-person interviews are not possible, pill count will be done over the phone. 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% and adherent if pills taken/pill prescribed\>80% (0=non-adherent, 1=adherent).

  1 year - 1.5 years

Secondary Outcomes (4)

• Correct Medication Dosing Over Past 24 Hours (24 Hour Recall)

  1 year

• Ask-12

  1 year

• Change in Estimated Glomerular Filtration Rate (eGFR), ml/Min/1.73m^2

  Value at 2 years minus value at baseline

• Re-hospitalization

  2 years

Study Arms (2)

Usual Care

NO INTERVENTION

Patients in this group will receive the usual standard of care.

Intervention

EXPERIMENTAL

Patients in this group will receive the TAKE IT strategy components.

Behavioral: TAKE IT Strategy

Interventions

TAKE IT Strategy BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age 21 or older
• \) 5 weeks to 24 months post kidney transplant
• \) English speaking
• \) primarily responsible for administering own medication
• \) owns a cell phone and comfortable receiving text messages
• \) has access to and proficiency using internet in home

You may not qualify if:

• any severe, uncorrectable vision, hearing or cognitive impairments

Sponsors & Collaborators

• Northwestern University: lead
• Mayo Clinic: collaborator
• Northwestern Memorial Hospital: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (2)

Mayo Clinic, Arizona

Scottsdale, Arizona, 85054, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

  PMID: 36094829 DERIVED

• Yoon ES, Hur S, Curtis LM, Wynia AH, Zheng P, Nair SS, Bailey SC, Serper M, Reese PP, Ladner DP, Wolf MS. A Multifaceted Intervention to Improve Medication Adherence in Kidney Transplant Recipients: An Exploratory Analysis of the Fidelity of the TAKE IT Trial. JMIR Form Res. 2022 May 5;6(5):e27277. doi: 10.2196/27277.

  PMID: 35511225 DERIVED

Limitations and Caveats

Sponsor requested to end enrollment early to focus on retention, with a final sample of 449 participants (700 planned). Therefore were not adequately powered. Due to the Coronavirus disease 2019 (COVID-19) pandemic, in-person interviews became remote resulting in pill count being captured over video or phone instead of an automated pill counter. Many subjects did not bring their medications at baseline as requested, so we were not able to adjust for baseline pill-count adherence as planned.

Results Point of Contact

• Title: Dr. Michael Wolf
• Organization: Northwestern University

mswolf@northwestern.edu

312-503-5592

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Division Chief - Division of General Internal Medicine

Model Details: Participants will be randomized to one of two arms: TAKE IT strategy or usual care.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 7, 2017
• Study Start: May 3, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 28, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)