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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.

Primary Purpose

Diabetic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Self-care management program
Sponsored by
University of Applied Sciences of Western Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Kidney Disease focused on measuring Diabetic nephropathies, Nursing, Multidisciplinary, Self-care, Quality of Life

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Lausanne Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sequence: ABBA A=usual care, B=self-care

Sequence BAAB

Sequence AABB

Sequence BBAA

Arm Description

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.

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Self-care
Self-care behavior will be measured using the French translated version of the Revised Summary of Diabetes Self-Care Activities(R-SDSCA)
The adherence to anti-hypertensive medication
The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)
Blood glucose control
The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C
Kidney function
The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio

Full Information

First Posted
October 18, 2013
Last Updated
May 17, 2016
Sponsor
University of Applied Sciences of Western Switzerland
Collaborators
University of Lausanne, University of Lausanne Hospitals, Leenaards Fondation, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01967901
Brief Title
Impact of Multidisciplinary Self-care Management of Diabetic Nephropathy on Quality of Life, Self-care Behavior, Glycemic Control, and Renal Function.
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences of Western Switzerland
Collaborators
University of Lausanne, University of Lausanne Hospitals, Leenaards Fondation, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic nephropathies, Nursing, Multidisciplinary, Self-care, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence: ABBA A=usual care, B=self-care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sequence BAAB
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sequence AABB
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sequence BBAA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-care management program
Intervention Description
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 Measure Information:
Title
Quality of life
Description
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
Secondary Outcome Measure Information:
Title
Self-care
Description
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
Title
The adherence to anti-hypertensive medication
Description
The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)
Time Frame
12 months
Title
Blood glucose control
Description
The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C
Time Frame
12 months
Title
Kidney function
Description
The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Shaha, PhD, RN
Organizational Affiliation
University of Lausanne- Faculty of Biology and Medicine, Institut universitaire de formation et de recherche en soins
Official's Role
Study Director
Facility Information:
Facility Name
University of Lausanne Hospitals
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27430216
Citation
Helou N, Talhouedec D, Shaha M, Zanchi A. The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol. BMC Nephrol. 2016 Jul 19;17(1):88. doi: 10.1186/s12882-016-0279-6.
Results Reference
derived

Learn more about this trial

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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