Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 23, 2020
Date Accepted: Feb 25, 2021
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Interprofessional medication adherence programme for patients with diabetic kidney disease: a mixed randomized controlled and qualitative trial protocol (PANDIA-IRIS)
ABSTRACT
Background:
Despite effective treatments, more than 30% of diabetic patients 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 programmes 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 programme led by pharmacists.
Objective:
The aim of this study is to define the impact of the duration of this medication adherence programme on long-term adherence and the clinical outcomes in DKD patients.
Methods:
The monocentric adherence programme consists of short, repeated motivational interviews focused on patients’ medication behaviour combined with the use of electronic monitors (EM) that record each daily opening. In total, 72 patients are randomized 1:1 in two parallel arms; the adherence programme will last 6 months in the first arm versus 12 months in the second. After the intervention phases, patients continue using their EM for a total of 24 months, but without receiving feedback. EM and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation (GEE) multimodelling respectively. The evolution of the ADVANCE and UKPDS clinical scores based on medication adherence will be analysed with GEE models. Patients’ satisfaction with the study will be assessed through qualitative interviews, which will be transcribed verbatim, coded and analysed for main themes.
Results:
The study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, two amendments to the protocol have been approved in June 2017 and October 2019. Patients’ recruitment began in April 2016 and ended in October 2020. In total, 73 patients have been included. Data collection is ongoing, and data analysis is planned for 2022.
Conclusions:
The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence programme on adherence and clinical outcomes of patients with diabetic kidney disease. Monitoring medication adherence during the post-intervention phase is innovative and will shed light on the duration of the intervention on medication adherence. Clinical Trial: The study has been registered at clinicaltrials.gov (n°NCT04190251_PANDIA IRIS).
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