University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011, Switzerland
NCT Number: NCT01967901
Diabetic Kidney Disease (DKD) is becoming a global health concern that affects largely the elderly population. Despite advances in pharmacological and management strategies, DKD remain associated with high morbidity and mortality. Patients living with such chronic disease, are expected, on daily basis to manage their self-care activities. Patients' non-adherence to the treatment is thought to be the major cause for the poor control and the occurrence of complications. Previous researchers have shown that multidisciplinary management of chronic disease can improve patients' self-care and outcomes. However, none of these programs was centered on self-care and targeted patients with DKD. A multidisciplinary self-care management program could improve the outcomes of patients with DKD, and delay the progression of the disease.
The aim of the study is to investigate the effect of a multidisciplinary self-care management program on self-care behavior, quality of life, medication adherence, glycemic control and renal function, in adults with DKD.
The study will use a cross-over design. 32 adult with DKD, will be randomly recruited from the Vaud University Medical Center, nephrology department and will be enrolled in the program for 12 month. All variables will be measured at baseline, three, six, nine and 12 month. We will measure the patients' self-care behavior, quality of life, adherence to the anti-hypertensive medication taking using, the Revised Summary of Diabetes Self-Care Activities questionnaire, the Audit of Diabetes-Dependent Quality of life questionnaire and the Medication Events Monitoring System. We will assess the patients' glycemic control by measuring the glycated hemoglobin and the renal function by measuring the serum creatinine and the microalbumin creatinine ratio.
The study will clearly show if a multidisciplinary self-care management program will improve the health outcomes of patients with DKD and will allow us to recommend the establishment of such a program.
Looking for future studies?
Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Lausanne, Canton of Vaud, 1011, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(The nephrologist will ensure patients' referral or follow-up in the case of a diagnosed cognitive deficit)
Exclusion criteria
The self-care management consists of the usual care with an additional multidisciplinary self-management program that includes additional home and clinic visits and telephone follow-ups made by the self-care management nurse and clinic visits to the dietician.
Time frame: 12 months
The Quality of life will be measured using the French version of the Audit of Diabetes-Dependent Quality of life (ADDQoL) measure at baseline, at the end of three months of follow-up, at the end of six months of follow-up, at the end of nine months of follow-up, and at the end of twelve months of follow-up.
Time frame: 12 months
Self-care behavior will be measured using the French translated version of the Revised Summary of Diabetes Self-Care Activities(R-SDSCA)
Time frame: 12 months
The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)
Time frame: 12 months
The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C
Time frame: 12 months
The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio
University of Applied Sciences of Western Switzerland
Other
Impact of a Multidisciplinary Self-care Management Program on Quality of Life, Self-care Behavior, Adherence to the Anti-hypertensive Treatment, Glycemic Control, and Renal Function in Adults Living With Diabetic Kidney Disease
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