Impact of Multidisciplinary Self-care Management of Diabetic Nephropathy on Quality of Life, Self-care Behavior, Glycemic Control, and Renal Function.

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967901
• Other study ID #: 37319/S-RAD13-07
• Status: Completed
• Phase: N/A
• First received: October 18, 2013
• Last updated: May 17, 2016
• Start date: March 2014
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: University of Applied Sciences of Western Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionSwitzerland: Laws and standards
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Age eighteen and more

• Clinical diagnoses of diabetes

• Clinical diagnosis of renal disease and an Estimated Glomerular Filtration Rate (eGFR) of less than 60ml/min calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD_EPI) formula and /or an Albumin/Creatinine ratio of 30mg/mmol or more.

• Free of cognitive deficit as determined by the recruiting nephrologist based on a normal score on the Short Portable Mental Status Questionnaire.

(The nephrologist will ensure patients' referral or follow-up in the case of a diagnosed cognitive deficit)

• Free of psychomotor skills limitations as determined by the physical examination of the medical doctor recruiting the patient.

• Able to read, write and speak in French

Exclusion Criteria:

• Terminal illness other than chronic kidney disease such as cancer or severe heart failure.

• Planned major surgical procedures.

• Patient on dialysis.

• Patient receiving nursing home care visits for the management of diabetes.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Behavioral:
• Self-care management program
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.

Locations

Country	Name	City	State
Switzerland	University of Lausanne Hospitals	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
University of Applied Sciences of Western Switzerland	Leenaards Fondation, Switzerland, University of Lausanne, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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.	12 months	No
Secondary	Self-care	Self-care behavior will be measured using the French translated version of the Revised Summary of Diabetes Self-Care Activities(R-SDSCA)	12 months	No
Secondary	The adherence to anti-hypertensive medication	The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)	12 months	No
Secondary	Blood glucose control	The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C	12 months	No
Secondary	Kidney function	The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio	12 months	No