Frailty Intervention Trial in End-Stage Patients on Dialysis

Study Overview
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Brief Summary
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The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients. Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). The frailty phenotyping will encompass a number of frailty assessments (including the Edmonton Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify the ideal frailty assessment tool. All patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months. Work package 2: Building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. Eligible patients, after informed consent, will be randomised into active or passive intervention. The active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty. The FITNESS project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.

Official Title
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Frailty Intervention Trial in End-Stage Patients on Dialysis: A Feasibility Study

Conditions
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Hemodialysis Complication, Nutritional Deficiency, Physical Activity

Intervention / Treatment
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* Behavioral: Multi-disciplinary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On hemodialysis Exclusion Criteria: Inability to give consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multi-disciplinary intervention arm<br>Multi-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team | Behavioral: Multi-disciplinary intervention<br>* Participants in the intervention group will receive a multifactorial, interdisciplinary, treatment program intended to target pre-frailty for a 4-month period following randomization (physical meetings at 2-monthly time points with telephone consultations between meetings). The interventions will be individually tailored to each participant based on their frailty characteristics at baseline and amended if other problems are identified during the intervention program. This intervention team will consist of a renal dietitian and physiotherapist, both of whom will be trained and accredited in behavioural therapy intervention skills, and will focus on improving nutritional status and physical strength through resistance exercise training. They will be supported by a Clinical Research Fellow who will provide additional medical assessment to determine any reversible medical causes of frailty.<br>|
| No Intervention: Control arm<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of frailty intervention study in haemodialysis patients | Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frailty status | Change in frailty score between baseline and end of study | 6-months | 
| Mortality | Difference in mortality episodes between randomised arms | 6-months | 
| Hospitalisation | Difference in episodes of hospitalisation between randomised arms | 6-months |