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

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ClinicalTrials.gov Identifier: NCT01967901
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
University of Lausanne
University of Lausanne Hospitals
Leenaards Fondation, Switzerland
Information provided by (Responsible Party):
Nancy Helou, University of Applied Sciences of Western Switzerland

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetic Kidney Disease Behavioral: Self-care management program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : March 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sequence: ABBA A=usual care, B=self-care

The usual care consists of patients' follow up by their usual nephrologist and endocrinologist or general practitioner.

Self-care management consists of a the addition of a 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.

In this sequence, patients will receive the usual care for 3 months. Then, they will cross-over to receive a multidisciplinary self-management for the following 6 months and then cross-over to a 3 months of usual care.

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.

Active Comparator: Sequence BAAB
Patients will receive the multidisciplinary self-management program for 3 months. Then, they will cross-over to usual care for the following 6 months and then cross-over to 3 months of multidisciplinary self-management
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.

Active Comparator: Sequence AABB
Patients will receive the usual care for two periods of three months, then they will cross-over to a period of 6 months of a multidisciplinary self-management
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.

Active Comparator: Sequence BBAA
Patients will receive the multidisciplinary self-management for two periods of three months, then they will cross-over to a period of 6 months of usual care.
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.




Primary Outcome Measures :
  1. Quality of life [ 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.


Secondary Outcome Measures :
  1. Self-care [ 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)

  2. The adherence to anti-hypertensive medication [ Time Frame: 12 months ]
    The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)

  3. Blood glucose control [ Time Frame: 12 months ]
    The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C

  4. Kidney function [ Time Frame: 12 months ]
    The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967901


Locations
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Switzerland
University of Lausanne Hospitals
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Applied Sciences of Western Switzerland
University of Lausanne
University of Lausanne Hospitals
Leenaards Fondation, Switzerland
Investigators
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Study Director: Maya Shaha, PhD, RN University of Lausanne- Faculty of Biology and Medicine, Institut universitaire de formation et de recherche en soins

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nancy Helou, Lecturer at University of Applied Sciences of Western Switzerland, PhD (c) at the University of Lausanne, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier: NCT01967901     History of Changes
Other Study ID Numbers: 37319/S-RAD13-07
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Nancy Helou, University of Applied Sciences of Western Switzerland:
Diabetic nephropathies
Nursing
Multidisciplinary
Self-care
Quality of Life

Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases