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Individualized intervention for frail non-dialysis elderly patients with chronic kidney disease: protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Frailty describes an age-related clinical state and can be regarded as a predictive factor for fall, disability, hospitalization, and death in the elderly. Previous studies proved that frailty could be reversed or attenuated by multi-disciplinary intervention. However, only a few studies have been performed in non-dialysis patients with chronic kidney disease. METHODS:A randomized parallel controlled trial will be conducted to compare an individualized intervention according to the consequence of the comprehensive geriatric assessment with routine treatment. A total of 242 individuals aged ?65?years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3-5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University. The participants will be followed-up for 30?days and 12?months. DISCUSSION:This protocol would be established to examine the efficiency of targeted intervention for frailty. If a positive consequence could be obtained, a novel treatment for frail elderly patients with chronic kidney disease who have never undergone dialysis can be carried out in routine clinical practice. TRIAL REGISTRATION:The trial was prospectively registered at the Chinese Clinical Trials Registry with the registration number ChiCTR-IOR-17013429 on November 17, 2017.

SUBMITTER: Chang J

PROVIDER: S-EPMC7199301 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Individualized intervention for frail non-dialysis elderly patients with chronic kidney disease: protocol for a randomized controlled trial.

Chang Jing J Gao Yun Y Fang Xiang-Yang XY Zhao Su-Mei SM Hou Yuan-Ping YP Sun Qian-Mei QM

BMC geriatrics 20200504 1

<h4>Background</h4>Frailty describes an age-related clinical state and can be regarded as a predictive factor for fall, disability, hospitalization, and death in the elderly. Previous studies proved that frailty could be reversed or attenuated by multi-disciplinary intervention. However, only a few studies have been performed in non-dialysis patients with chronic kidney disease.<h4>Methods</h4>A randomized parallel controlled trial will be conducted to compare an individualized intervention acco ...[more]

PMID: 32366214

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Project description:Frail elderly people need an integrated and coordinated care. The two-armed study "Continuum of care for frail elderly people" is a multi-professional and multidimensional intervention for frail community-dwelling elderly people. It was designed to evaluate whether the intervention programme for frail elderly people can reduce the number of visits to hospital, increase satisfaction with health and social care and maintain functional abilities. The implementation process is explored and analysed along with the intervention. In this paper we present the study design, the intervention and the outcome measures as well as the baseline characteristics of the study participants.The study is a randomised two-armed controlled trial with follow ups at 3, 6 and 12 months. The study group includes elderly people who sought care at the emergency ward and discharged to their own homes in the community. Inclusion criteria were 80 years and older or 65 to 79 years with at least one chronic disease and dependent in at least one activity of daily living. Exclusion criteria were acute severely illness with an immediate need of the assessment and treatment by a physician, severe cognitive impairment and palliative care. The intention was that the study group should comprise a representative sample of frail elderly people at a high risk of future health care consumption. The intervention includes an early geriatric assessment, early family support, a case manager in the community with a multi-professional team and the involvement of the elderly people and their relatives in the planning process.The design of the study, the randomisation procedure and the protocol meetings were intended to ensure the quality of the study. The implementation of the intervention programme is followed and analysed throughout the whole study, which enables us to generate knowledge on the process of implementing complex interventions. The intervention contributes to early recognition of both the elderly peoples' needs of information, care and rehabilitation and of informal caregivers' need of support and information. This study is expected to show positive effects on frail elderly peoples' health care consumption, functional abilities and satisfaction with health and social care.ClinicalTrials.gov: NCT01260493.

Project description:IntroductionFrailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.Methods and analysisThe EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).Ethics and disseminationEthical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.Trial registration numberISRCTN87708989.

Project description:BACKGROUND:In observational studies, drinking more water associates with a slower rate of kidney function decline; whether the same is true in a randomized controlled trial is unknown. OBJECTIVE:To examine the 1-year effect of a higher vs usual water intake on estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease. DESIGN:Parallel-group randomized controlled trial. SETTING:Nine centers in Ontario, Canada. Enrollment and randomization occurred between May 2013 and May 2016; follow-up for the primary outcome will continue until June 2017. PARTICIPANTS:Adults (n = 631) with stage 3 chronic kidney disease (eGFR 30-60 mL/min/1.73 m2) and microalbuminuria. INTERVENTION:The high water intake group was coached to increase their oral water intake by 1.0 to 1.5 L/day (depending on sex and weight), over and above usual consumed beverages, for a period of 1 year. The control group was coached to maintain their usual water intake during this time. MEASURES:Participants provided 24-hour urine samples at baseline and at 6 and 12 months after randomization; urine samples were analyzed for volume, creatinine, osmolality, and the albumin-to-creatinine ratio. Blood samples were obtained at baseline and at 3- to 6-month intervals after randomization, and analyzed for creatinine, copeptin, osmolality, and electrolytes. Other measures collected included health-related quality of life, blood pressure, body mass index, and diet. PRIMARY OUTCOME:The between-group change in eGFR from baseline (prerandomization) to 12 months after randomization. SECONDARY OUTCOMES:Change in plasma copeptin concentration, 24-hour urine albumin-to-creatinine ratio, measured creatinine clearance, estimated 5-year risk of kidney failure (using the 4-variable Kidney Failure Risk Equation), and health-related quality of life. PLANNED ANALYSIS:The primary analysis will follow an intention-to-treat approach. The between-group change in eGFR will be compared using linear regression. Supplementary analyses will examine alternative definitions of eGFR change, including annual percentage change, rate of decline, and rapid decline (a P value <0.05 will be interpreted as statistically significant if there is concordance with the primary outcome). TRIAL REGISTRATION:This randomized controlled trial has been registered at www.clinicaltrials.gov; government identifier: NCT01766687.

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Individualized intervention for frail non-dialysis elderly patients with chronic kidney disease: protocol for a randomized controlled trial.

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Individualized intervention for frail non-dialysis elderly patients with chronic kidney disease: protocol for a randomized controlled trial.

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