Abstract
BackgroundDespite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists.ObjectiveThe aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD.MethodsThis monocentric adherence program consists of short, repeated motivational interviews focused on patients’ medication behaviors combined with the use of electronic monitors containing patients’ medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients’ satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes.ResultsThis study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022.ConclusionsThe PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence.Trial RegistrationClinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251International Registered Report Identifier (IRRID)DERR1-10.2196/25966
Highlights
Approximately 463 million people have been diagnosed with diabetes worldwide [1]
Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point
The PANDIA-IRIS study is based on a routine medication adherence program led by pharmacists
Summary
Approximately 463 million people have been diagnosed with diabetes worldwide [1]. Patients with DKD are among the most complex patients receiving diabetes care Their care is multifactorial and multidisciplinary, involving different groups of health care providers. The multifactorial approach involves pharmacological treatment of various cardiovascular risk factors, including glucose levels, cholesterol levels, and blood pressure levels, and the pharmacological treatment of complications secondary to the reduced renal function. A feasibility study in patients with DKD who participated in an intervention combining a medication plan and regular phone calls by a specialist nurse did not demonstrate an increase in the medication adherence [10]. It is necessary to better understand the needs of patients with DKD in terms of medication management to achieve better medication adherence and clinical outcomes and slow cardiovascular and renal disease progression. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l’adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists
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