scholarly journals Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS)

10.2196/25966 ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. e25966
Author(s):  
Carole Bandiera ◽  
Jennifer Dotta-Celio ◽  
Isabella Locatelli ◽  
Dina Nobre ◽  
Grégoire Wuerzner ◽  
...  

Background Despite 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. Objective The 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. Methods This 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. Results This 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. Conclusions The 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 Registration Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251 International Registered Report Identifier (IRRID) DERR1-10.2196/25966

2020 ◽  
Author(s):  
Carole Bandiera ◽  
Jennifer Dotta-Celio ◽  
Isabella Locatelli ◽  
Dina Nobre ◽  
Grégoire Wuerzner ◽  
...  

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. CLINICALTRIAL The study has been registered at clinicaltrials.gov (n°NCT04190251_PANDIA IRIS).


2021 ◽  
Vol 22 (11) ◽  
pp. 5808
Author(s):  
Annalisa Giandalia ◽  
Alfio Edoardo Giuffrida ◽  
Guido Gembillo ◽  
Domenico Cucinotta ◽  
Giovanni Squadrito ◽  
...  

Diabetic kidney disease (DKD) is one of the most serious complications of both type 1 (T1DM) and type 2 diabetes mellitus (T2DM). Current guidelines recommend a personalized approach in order to reduce the burden of DM and its complications. Recognizing sex and gender- differences in medicine is considered one of the first steps toward personalized medicine, but the gender issue in DM has been scarcely explored so far. Gender differences have been reported in the incidence and the prevalence of DKD, in its phenotypes and clinical manifestations, as well as in several risk factors, with a different impact in the two genders. Hormonal factors, especially estrogen loss, play a significant role in explaining these differences. Additionally, the impact of sex chromosomes as well as the influence of gene–sex interactions with several susceptibility genes for DKD have been investigated. In spite of the increasing evidence that sex and gender should be included in the evaluation of DKD, several open issues remain uncovered, including the potentially different effects of newly recommended drugs, such as SGLT2i and GLP1Ras. This narrative review explored current evidence on sex/gender differences in DKD, taking into account hormonal, genetic and clinical factors.


2021 ◽  
Author(s):  
Haryana Y. Thomas ◽  
Ashlee N. Ford Versypt

Diabetic kidney disease is a health burden that is becoming more prevalent in the US and worldwide. The limited options for treating and preventing diabetic kidney disease are in part due to gaps in our understanding of the progression of diabetic kidney damage and its impacts on cellular function. An important cellular function in the kidney glomerulus is intercellular communication via the release and uptake of soluble cytokines and growth factors. In diabetic kidney disease, excess collagen deposition alters the mesangial matrix properties, which, we hypothesize, diminishes the intercellular signaling between key glomerular cells. To test our hypothesis, we utilized established mathematical models of transport to study the impact of pathological deposition on the ability of cells to communicate via intercellular signaling. Our analysis reveals that pathological collagen deposition can enhance the signaling range of the glomerular cells rather than diminishing it.


2021 ◽  
Vol 6 (4) ◽  
pp. S274
Author(s):  
E. Zeltyn-Abramov M. ◽  
N. Belavina I. ◽  
N. Frolova F. ◽  
N. Poteshkina G. ◽  
N. Klochkova N. ◽  
...  

2020 ◽  
pp. 084653711989953
Author(s):  
Adrian Marcuzzi ◽  
Stella Wang ◽  
Pascal N. Tyrrell ◽  
Pradeep Ravichandran ◽  
Danny Marcuzzi ◽  
...  

Purpose: To investigate whether a significant difference exists between the calcification of the common iliac arteries (CIAs) and the external iliac arteries (EIAs) and test for associations between clinical factors and the distribution of calcification. Methods: A retrospective review of renal transplant candidates who underwent a routine preoperative unenhanced computed tomography yielded 214 patients. Agatston scores for the patients’ left CIA, left EIA, right CIA, and right EIA were assigned. A retrospective search of patient records screened for 5 clinical factors (diabetes, hypertension, coronary artery disease [CAD], smoking, and dialysis). Data were assessed using a 2-sided t test, odds ratio, and a multivariate linear regression calculated through generalized estimating equation (GEE). Results: The log-transformed Agatston scores in the CIA were found to be significantly greater than that in the EIA ( t = 9.57, P < .0001), with a mean difference of 1.5078 (95% confidence interval: 1.1962-1.8194), indicating relative EIA sparing. There were no significant differences in calcification between the right and left sides. Generalized estimating equation found that CAD and smoking demonstrated independent positive associations with EIA sparing (GEE = 2.6464 [ P = .0197] and 1.9092 [ P = .0470], respectively). Age was also significantly associated and indicated that EIA sparing remained relatively constant throughout patients’ lives (GEE = 1.0711 [ P < .0001]). Conclusion: This study has demonstrated statistically significant EIA sparing in end-stage renal disease patients and identified CAD and smoking as associated factors. This phenomenon warrants further investigation into its biological mechanisms and the impact of EIA sparing on outcomes following transplants.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Sho Kinguchi ◽  
Hiromichi Wakui ◽  
Yuzuru Ito ◽  
Yoshinobu Kondo ◽  
Kengo Azushima ◽  
...  

AbstractWe investigated the impact of basal dietary sodium intake on the dapagliflozin-induced changes in albuminuria and blood pressure (BP) measured at home in patients with diabetic kidney disease (DKD).This was a secondary analysis of the Y-AIDA Study, in which DKD patients with estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73 m2 and urinary albumin-to-creatinine ratio (UACR) ≥ 30 mg/g creatinine were administered dapagliflozin for 24 weeks, and dapagliflozin significantly improved albuminuria levels and home BP profiles. The effects on UACR, home-measured BP, and eGFR were compared between high- and low-sodium intake groups (HS and LS groups), which were created using baseline urinary sodium-to-creatinine ratio of 84 participants with available basal sodium-to-creatinine ratios. At baseline, clinic-/home-measured BPs, UACR, and eGFR, were comparable in the two groups. After 24 weeks, the reductions from baseline in ln-UACR were comparable in the two groups. In contrast, the reductions in evening home systolic BP and eGFR from baseline were larger in HS than in LS (BP: − 13 ± 2.08 vs. − 6 ± 1.88, P = 0.020; eGFR: − 3.33 ± 1.32 vs. 0.37 ± 1.29, P = 0.049). The home BP-lowering effects of dapagliflozin are larger in HS than LS, concomitant with a larger reduction in eGFR, suggesting a dapagliflozin-induced improvement in glomerular relative hyperfiltration in HS.


Sign in / Sign up

Export Citation Format

Share Document