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| Name | Class |
|---|---|
| University of Lausanne | OTHER |
| University of Lausanne Hospitals | OTHER |
| Leenaards Fondation, Switzerland | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence: ABBA A=usual care, B=self-care | Active Comparator | 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. |
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| Sequence BAAB | Active Comparator | 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 |
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| Sequence AABB | Active Comparator | 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 |
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| Sequence BBAA | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-care management program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The adherence to anti-hypertensive medication |
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Inclusion Criteria:
(The nephrologist will ensure patients' referral or follow-up in the case of a diagnosed cognitive deficit)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maya Shaha, PhD, RN | University of Lausanne- Faculty of Biology and Medicine, Institut universitaire de formation et de recherche en soins | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne Hospitals | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39171639 | Derived | Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3. | |
| 36645291 | Derived | Hodson EM, Cooper TE. Altered dietary salt intake for preventing diabetic kidney disease and its progression. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD006763. doi: 10.1002/14651858.CD006763.pub3. |
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The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)
| 12 months |
| Blood glucose control | The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C | 12 months |
| Kidney function | The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio | 12 months |
| 27430216 | Derived | 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. |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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