title: 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.
abstract: Diabetic kidney disease, a global health issue, remains associated with high morbidity and mortality. Previous research has shown that multidisciplinary management of chronic disease can improve patient outcomes. The effect of multidisciplinary self-care management on quality of life and renal function of patients with diabetic kidney disease has not yet been well established.
  
  
  
  The aim of this study is to evaluate the impact of a multidisciplinary self-care management program on quality of life, self-care behavior, adherence to anti-hypertensive treatment, glycemic control, and renal function of adults with diabetic kidney disease. A uniform balanced cross-over design is used, with the objective to recruit 40 adult participants with diabetic kidney disease, from public and private out-patient settings in French speaking Switzerland. Participants are randomized in equal number into four study arms. Each participant receives usual care alternating with the multidisciplinary self- care management program. Each treatment period lasts three months and is repeated twice at different time intervals over 12 months depending on the cross-over arm. The multidisciplinary self-care management program is led by an advanced practice nurse and adds nursing and dietary consultations and follow-ups, to the habitual management provided by the general practitioner, the nephrologist and the diabetologist. Data is collected every three months for 12 months. Quality of life is measured using the Audit of Diabetes-Dependent Quality of Life scale, patient self-care behavior is assessed using the Revised Summary of Diabetes Self-Care Activities, and adherence to anti-hypertensive therapy is evaluated using the Medication Events Monitoring System. Blood glucose control is measured by the glycated hemoglobin levels and renal function by serum creatinine, estimated glomerular filtration rate and urinary albumin/creatinine ratio. Data will be analyzed using STATA version 14.
  
  
  
  The cross-over design will elucidate the responses of individual participant to each treatment, and will allow us to better evaluate the use of such a design in clinical settings and behavioral studies. This study also explores the impact of a theory-based nursing practice and its implementation into a multidisciplinary context.
  
  
  
  ClinicalTrials.gov identifier: NCT01967901 , registered on the 18th of October 2013.
authors.affiliation: HESAV, The University of Health Sciences (HES-SO), Av. de Beaumont 21, 1011, Lausanne, Switzerland. nancy.helou@hesav.ch.|Faculty of Biology and Medicine, University Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Biopôle 2, Route de la Corniche 10, 1010, Lausanne, Switzerland. nancy.helou@hesav.ch.
authors.forename: Nancy
authors.initials: N
authors.lastname: Helou
authors.affiliation: Clinique de La Source, Avenue Vinet 30, 1004, Lausanne, Switzerland.
authors.forename: Dominique
authors.initials: D
authors.lastname: Talhouedec
authors.affiliation: Faculty of Biology and Medicine, University Institute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Biopôle 2, Route de la Corniche 10, 1010, Lausanne, Switzerland.
authors.forename: Maya
authors.initials: M
authors.lastname: Shaha
authors.affiliation: Services of Nephrology, Diabetes and Endocrinology, Department of Internal Medicine, Centre Hospitalier Universitaire Vaudois (CHUV), Rue du Bugnon 17, 1011, Lausanne, Switzerland.
authors.forename: Anne
authors.initials: A
authors.lastname: Zanchi
mesh_terms: D000419:Albuminuria / Q000652:urine; D000959:Antihypertensive Agents / Q000627:therapeutic use; D003404:Creatinine / Q000097:blood / Q000652:urine; D018592:Cross-Over Studies; D003928:Diabetic Nephropathies / Q000097:blood / Q000451:nursing / Q000503:physiopathology* / Q000628:therapy*; D004032:Diet; D004046:Dietetics; D037001:Directive Counseling; D005919:Glomerular Filtration Rate; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D055118:Medication Adherence; D010348:Patient Care Team; D057184:Practice Patterns, Nurses'; D011788:Quality of Life; D012107:Research Design; D012648:Self Care
chemical_list: D000959:Antihypertensive Agents; D003404:Creatinine; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: Diabetic nephropathies; Diabetic nephropathy; Interdisciplinary studies; Multidisciplinary care; Self-care