NCT03782519

Quality of Life of Frail Aged Patients in Incremental Hemodialysis

Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 783 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions. An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.

Conditions

• Renal Dialysis
• Kidney Failure, Chronic
• Frailty

Interventions

Type	Name	Description
OTHER	Dialysis frequency reduction	At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)
OTHER	Frailty diagnosis	Before randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question)

Timeline

• Start date: 2019-05-09
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2018-12-20
• Last updated: 2022-04-05

Locations

1 site across 1 country: France