Clinical trial NCT03104868: Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Official title: Transplant Regimen Adherence for Kidney Recipients by Engaging Information Technologies: The TAKE IT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Northwestern Memorial Hospital
name: University of Illinois at Chicago
First posted: 2017-04-07
Enrollment: 449
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two arms: TAKE IT strategy or usual care.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Among patients receiving a kidney transplant (KT), the 5-year risk of organ (graft) failure is high; 30% for deceased donor and 27% for living donor recipients. Medication non-adherence is a leading root cause of graft failure, and KT recipients have the highest reported rate of poor adherence (\~35%) among all organ transplant recipients. Despite many attempts, there have been few successful interventions evaluated to date that have significantly improved KT recipients' regimen adherence and subsequent health outcomes over time.

There are many reasons why individuals may not take medication regimens as prescribed, including but not limited to: forgetfulness, misunderstanding, regimen complexity, side effects, health issues, social support, motivation and cost. Therefore no single solution can address all patients. A healthcare team must understand the precise nature of a patient's adherence barriers in order to properly respond. Yet medication adherence is not clinically assessed as part of routine post-transplant care, and prior studies have found that medical staff cannot readily identify poor adherence among patients, let alone the reasons why. Using evidence from the research team's extensive previous studies in other chronic disease contexts, the investigators will implement and comprehensively test a potentially low cost, 'low touch', thus highly scalable intervention: the Transplant regimen Adherence for Kidney recipients by Engaging Information Technologies (TAKE IT) strategy.

The TAKE IT strategy leverages a transplant center's electronic health record and a web-based patient portal, as well as mobile technology to: 1) educate patients on their prescribed Rx regimens, 2) help them organize their daily regimen schedule in the most efficient manner, 3) remind them via Short Message Service (SMS) text when to take their medicine, 4) routinely monitor regimen use, and 5) provide care alerts to engage appropriate transplant center clinical staff (e.g. nurse coordinator, pharmacist, social worker) when medication concerns are detected. All components of the TAKE IT strategy have been developed with prior NIH support, refined with 'user' input (patient, family, clinic staff), and their efficacy tested in non-transplant settings.

The research team's primary aim and hypotheses (H) are to:

Aim 1 Test the effectiveness of the TAKE IT strategy, compared to usual care, to improve KT recipients':

H1 treatment knowledge (indications, potential side effects, demonstrated proper use) H2 medication use (regimen adherence via self-report, pill count, pharmacy records, tacrolimus levels) H3 transplant-specific outcomes (Δ estimated glomerular filtration rate (eGFR), quality of life, re-hospitalization) H4 chronic disease outcomes (blood pressure, HbA1c) They will conduct a 2-arm, patient-randomized controlled trial at two large, diverse transplant centers (Northwestern University; Mayo Clinic). 300 KT recipients within 3 months of transplant ('de novo') and 400 'established' patients between 18 months and 3 years post-KT will be recruited and followed for 2 years (N=700 patients; n=350 per site and n=175 per study arm within each site). In-person interviews will be conducted at baseline, 6, 12, 18 and 24 months. To determine proximal effects of the TAKE IT strategy, a telephone interview will also be administered 6 weeks post-baseline. Electronic health and pharmacy records will be ascertained to capture medication adherence and clinical outcomes.

The secondary aims are to:

Aim 2 Examine the persistence of any effects of the TAKE IT strategy on outcomes over 2 years among new and established KT recipients.

Aim 3 Evaluate the fidelity of each component of the TAKE IT strategy over time, and investigate any patient, provider, or transplant center barriers to implementation.

Aim 4 Determine the costs of delivering the TAKE IT strategy from a transplant center perspective.

Additionally, the investigators will closely evaluate the implementation of all components of the TAKE IT strategy from launch through 2 years follow-up (Aim 2). Their evaluation will include a range of process outcomes to assess the intervention's reliability and sustainability. These findings will determine whether any specific modifications to the TAKE IT strategy are necessary (Aim 3). Finally, the team will estimate the incremental costs of implementing and sustaining the TAKE IT strategy from the perspective of two transplant centers (Aim 4).

Eligibility criteria: Inclusion Criteria:

* 1) age 21 or older
* 2) 5 weeks to 24 months post kidney transplant
* 3) English speaking
* 4) primarily responsible for administering own medication
* 5) owns a cell phone and comfortable receiving text messages
* 6) has access to and proficiency using internet in home

Exclusion Criteria:

* any severe, uncorrectable vision, hearing or cognitive impairments

Primary outcomes:
measure: Rx Pill Count
timeFrame: 1 year - 1.5 years
Secondary outcomes:
measure: Correct Medication Dosing Over Past 24 Hours (24 Hour Recall)
timeFrame: 1 year
measure: Ask-12
timeFrame: 1 year
measure: Change in Estimated Glomerular Filtration Rate (eGFR), ml/Min/1.73m^2
timeFrame: Value at 2 years minus value at baseline
measure: Re-hospitalization
timeFrame: 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic, Arizona
state: Arizona
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
citation: 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.
citation: 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.