SystemCHANGE: An Intervention for Medication Change in Adult Kidney Transplant Patients

NCT02416479 | Unknown Phase 3 DMC

• 1 other identifier: 0039040
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

With kidney transplant (KT) recipients as our exemplar population, our goal is to develop and test interventions that increase medication adherence (MA) in chronically ill adults. Among adult KT recipients, non-adherence to immunosuppressive medications (MNA) is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of KT patients experience MNA even though the problem is preventable. Adherence intervention studies have proven marginally effective for those with acute and chronic illnesses and ineffective for adult KT recipients. Using a randomized controlled trial design with an attention-control group, this R01 will test an innovative 6-month SystemCHANGE intervention to enhance immunosuppressive MA in adult non-adherent KT recipients. This intervention shows great promise for increasing MA with a large effect size of 1.4 in our pilot study. Grounded in the socio-ecological model, SystemCHANGE seeks to systematically improve MA behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. The Medication Event Monitoring System cap, which contains microelectronics that record the date and time of the cap removal, will be used to measure MA. Persistence of the MA behavior change will be examined by evaluating the difference in MA between the two groups during the 6-month maintenance phase. Mediators and moderators of MA will be examined. Health outcomes will be compared and a cost-effectiveness analysis will be conducted.

Conditions

Kidney Disease

Keywords

medication adherence; outcomes; intervention; randomized controlled trial

Outcome Measures

Primary Outcomes (3)

• Medication Adherence Change from Baseline to 6 Months

  Medication adherence score of .85 or greater

  6 months

• Medication Adherence Change from 6 Months to 12 Months

  Medication adherence score of .85 or greater

  12 months

• Medication Adherence Change from Baseline to 12 Months

  Medication adherence score of .85 or greater

  12

Secondary Outcomes (8)

• Creatinine

  12 months

• Infection

  12 months

• Acute rejection

  12 months

• Chronic rejection

  12 months

• BUN

  12 months

Study Arms (2)

SystemCHANGE

EXPERIMENTAL

SystemCHANGE supports patient-designed, interventionist-guided, small experiments to: 1) assess individual systems (including important others who shape medication taking) and the system's impact on medication taking and propose individual system solutions to improve MA, 2) implement the proposed individual systems' solutions to improve MA, 3) track MA data, and 4) evaluate MA data.

Behavioral: SystemCHANGE

Patient-education attention-control

ACTIVE COMPARATOR

The 6-month Patient education attention-control (AC) intervention includes 6 transplant educational materials, covering healthy post-transplant behavior, developed by the International Transplant Nurses Society. The RA calls Pps at 1, 2, 3, 4, 5 and 6 months to review the brochure information and answer any questions about it.

Behavioral: Patient-education attention control

Interventions

SystemCHANGE BEHAVIORAL

SystemCHANGE self-management supports patient-designed, interventionist-guided, small experiments using Deming's Plan-Do-Check-Act cycle26 to: (1) assess individual systems (including important others who shape medication taking), how they influence medication taking and their proposals for improving medication adherence, (2) implement the proposed individual systems' solutions to improve adherence, (3) track adherence data, and (4) evaluate adherence data.

SystemCHANGE

Patient-education attention control BEHAVIORAL

The 6-month Patient education attention-control (AC) intervention includes 6 transplant educational materials, covering healthy post-transplant behavior, developed by the International Transplant Nurses Society. The RA calls Pps at 1, 2, 3, 4, 5 and 6 months to review the brochure information and answer any questions about it.

Patient-education attention-control

Eligibility Criteria

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

You may qualify if:

• age 18 years or older,
• prescribed at least 1 immunosuppressive medication taken twice a day,
• functioning KT (not on dialysis),
• has received a kidney-only transplant,
• agreement from the transplant physician and nephrologist that individual is able to participate in the study,
• able to open a MEMS cap as assessed by the Research Assistant (RA) asking if there is any problem with opening pill bottle caps,
• able to administer immunosuppressive medications to self,
• has a telephone or has access to a telephone,
• has no cognitive impairment as determined by a score of 4 or greater on the 6-item Telephone Mental Status Screen Derived from the Mini-Mental Status Exam,
• has no other diagnoses that may shorten life span, such as metastatic cancer,
• is not currently hospitalized,
• receives post-transplant care by the Missouri or Tennessee transplant programs.

You may not qualify if:

• None

Sponsors & Collaborators

• Cynthia Russell: lead
• University of Tennessee: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (1)

University of Missouri-Kansas City

Kansas City, Missouri, 64108, United States

Location

Related Publications (3)

• 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

• Russell CL, Hathaway D, Remy LM, Aholt D, Clark D, Miller C, Ashbaugh C, Wakefield M, Ye S, Staggs VS, Ellis RJ, Goggin K. Improving medication adherence and outcomes in adult kidney transplant patients using a personal systems approach: SystemCHANGE results of the MAGIC randomized clinical trial. Am J Transplant. 2020 Jan;20(1):125-136. doi: 10.1111/ajt.15528. Epub 2019 Aug 20.

  PMID: 31291507 DERIVED

• Russell CL, Moore S, Hathaway D, Cheng AL, Chen G, Goggin K. MAGIC Study: Aims, Design and Methods using SystemCHANGE to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients. BMC Nephrol. 2016 Jul 16;17(1):84. doi: 10.1186/s12882-016-0285-8.

  PMID: 27421884 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2015
• First Posted: April 15, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

US (1)