| Literature DB >> 31291507 |
Cynthia L Russell1, Donna Hathaway2, Laura M Remy1, Dana Aholt1, Debra Clark2, Courtney Miller1, Catherine Ashbaugh3, Mark Wakefield3, Sangbeak Ye1, Vincent S Staggs4, Rebecca J Ellis5, Kathy Goggin4.
Abstract
This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.Entities:
Keywords: clinical research/practice; clinical trial; health services and outcomes research; immunosuppressant; immunosuppression/immune modulation; kidney transplantation/nephrology
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Year: 2019 PMID: 31291507 PMCID: PMC7179766 DOI: 10.1111/ajt.15528
Source DB: PubMed Journal: Am J Transplant ISSN: 1600-6135 Impact factor: 8.086