Qualifragilys: Quality of Life of Frail Aged Patients in Incremental Hemodialysis

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03782519

Collaborator

(none)

783

Enrollment

Location

Arms

42.8

Anticipated Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Dialysis Kidney Failure, Chronic Frailty	Other: Dialysis frequency reduction Other: Frailty diagnosis	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

783 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 9, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Incremental hemodialysis Patients who will begin HD with two treatment sessions per week	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)
Active Comparator: Conventional hemodialysis Patients who will begin HD three times a week	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)

Arm

Intervention/Treatment

Experimental: Incremental hemodialysis

Patients who will begin HD with two treatment sessions per week

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)

Active Comparator: Conventional hemodialysis

Patients who will begin HD three times a week

Other: Frailty diagnosis

Outcome Measures

Primary Outcome Measures

Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36) [One year after the initiation of HD]
Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL) [One year after the initiation of HD]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For all patients (incident HD patients):

Patient aged over 60 years
Signature of informed consent
Affiliation to a French social security or receiving such a scheme
Patient with Chronic Kidney Disease Stage 5 (GFR <15 ml/min/1.73m2)
Urine output > 0,5 L per day
Kru ≥ 2 ml/min
Outpatient with scheduled start of HD
Understand and read french

For randomized patients (frail incident HD patients):

Frailty according to L. Fried criteria: score greater than or equal to 3/5

Exclusion Criteria:

Inability to understand the reasons for the study; psychiatric disorders
Active and/or treated neoplastic disease
Scheduled kidney transplantation within 6 months
Solid organ transplanted patient receiving immunosuppressive therapy
Estimated life expectancy < 6 months
Patient with diagnosis of severe chronic heart failure (> 2 congestive heart failure episodes requiring hospitalization in the year preceding the start of HD)
Legal disability or limited legal capacity
Patient without health insurance
Pregnant
Patient in the period of exclusion of another study
Uncooperative patient