Quality of Life of Frail Aged Patients in Incremental Hemodialysis

Frailty Clinical Trial

— Qualifragilys  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03782519
• Other study ID #: N/2016/75
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Charline Vauchy, PhD
• Phone: +33381218875
• Email: cvauchy[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 783
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• Kidney Failure, Chronic
• Renal Dialysis
• Renal Insufficiency

Intervention

Other:
• Dialysis frequency reduction
At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)
• 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)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)		One year after the initiation of HD
Primary	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