Impact of Multidisciplinary Self-care Management of Diabetic Nephropathy on Quality of Life, Self-care Behavior, Glycemic Control, and Renal Function.
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
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Vaud
-
Lausanne, Vaud, Suíça, 1011
- University of Lausanne Hospitals
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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. |
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.
|
|
Comparador Ativo: 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
|
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.
|
|
Comparador Ativo: 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
|
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.
|
|
Comparador Ativo: 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Quality of life
Prazo: 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.
|
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-care
Prazo: 12 months
|
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
Prazo: 12 months
|
The adherence to anti-hypertensive medication taking will be measured using the Medication Events Monitoring system (MEMS)
|
12 months
|
|
Blood glucose control
Prazo: 12 months
|
The blood glucose control will be evaluated through the measurement of the glycated hemoglobin HbA1C
|
12 months
|
|
Kidney function
Prazo: 12 months
|
The kidney function will be evaluated through the measurement of the serum creatinine, and the microalbumin creatinine ratio
|
12 months
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Diretor de estudo: Maya Shaha, PhD, RN, University of Lausanne- Faculty of Biology and Medicine, Institut universitaire de formation et de recherche en soins
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 37319/S-RAD13-07
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .