Quality of Life of Frail Aged Patients in Incremental Hemodialysis

NCT03782519 | Unknown

• 1 other identifier: N/2016/75
• Study Type: interventional
• Target: 783
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Dialysis; Kidney Failure, Chronic; Frailty

Keywords

Incremental Hemodialysis; Nephrology

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Incremental hemodialysis

EXPERIMENTAL

Patients who will begin HD with two treatment sessions per week

Other: Dialysis frequency reduction; Other: Frailty diagnosis

Conventional hemodialysis

ACTIVE COMPARATOR

Patients who will begin HD three times a week

Other: Frailty diagnosis

Interventions

Dialysis frequency reduction OTHER

At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)

Incremental hemodialysis

Frailty diagnosis OTHER

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)

Conventional hemodialysis; Incremental hemodialysis

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Uncooperative patient

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 26027598 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cécile Courivaud, MD, PhD

  Nephrology, Dialysis and Renal Transplantation - CHU Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline Vauchy, PhD

CONTACT

+33381218875; cvauchy@chu-besancon.fr

Ingrid Tissot

CONTACT

+33381218427; itissot@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 20, 2018
• Study Start: May 9, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)