Quality of Life of Frail Aged Patients in Incremental Hemodialysis (Qualifragilys)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure, Chronic; Frailty; Renal Dialysis
• Intervention / Treatment: Other: Dialysis frequency reduction; Other: Frailty diagnosis

• Study Type: Interventional
• Enrollment (Anticipated): 783
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingrid Tissot; Phone Number: +33381218427; Email: itissot@chu-besancon.fr

Study Locations

• France
  • Besançon, France, 25000
    • Recruiting
    • Centre Hospitalier Universitaire de Besancon
    • Principal Investigator: Cécile Courivaud, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besançon
• Investigators: Principal Investigator: Cécile Courivaud, MD, PhD, Nephrology, Dialysis and Renal Transplantation - CHU Besançon

Publications and helpful links

General Publications

• Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Nephrology; Incremental Hemodialysis
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Frailty
• Other Study ID Numbers: N/2016/75

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No