Frailty Intervention Trial in End-Stage Patients on Dialysis

Not Applicable

Active, not recruiting

• Conditions: Nutritional Deficiency; Hemodialysis Complication; Physical Activity
• Interventions: Behavioral: Multi-disciplinary intervention

• Registration Number: NCT03071107
• Lead Sponsor: Adnan Sharif

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-25
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Study Start: 2017-12-01
• Primary Completion: 2019-06-15
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-10
• Last Update Posted: 2020-06-12
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• On hemodialysis

Exclusion Criteria

• Inability to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-disciplinary intervention arm	Multi-disciplinary intervention	Multi-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team

Primary Outcome Measures

Name	Time	Method
Feasibility of frailty intervention study in haemodialysis patients	6-months	Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients

Secondary Outcome Measures

Name	Time	Method
Change in frailty status	6-months	Change in frailty score between baseline and end of study
Hospitalisation	6-months	Difference in episodes of hospitalisation between randomised arms
Mortality	6-months	Difference in mortality episodes between randomised arms

Trial Locations

Locations (1)

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom