Frailty Intervention Trial in End-Stage Patients on Dialysis

NCT03071107 | Unknown

• 1 other identifier: FITNESS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; Nutritional Deficiency; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Feasibility of frailty intervention study in haemodialysis patients

  Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients

  6-months

Secondary Outcomes (3)

• Change in frailty status

  6-months

• Mortality

  6-months

• Hospitalisation

  6-months

Study Arms (2)

Multi-disciplinary intervention arm

ACTIVE COMPARATOR

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

Behavioral: Multi-disciplinary intervention

Control arm

NO INTERVENTION

Standard of care

Interventions

Multi-disciplinary intervention BEHAVIORAL

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.

Multi-disciplinary intervention arm

Eligibility Criteria

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

You may qualify if:

• On hemodialysis

You may not qualify if:

• Inability to give consent

Sponsors & Collaborators

• Adnan Sharif: lead

Study Sites (1)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2WB, United Kingdom

Location

Related Publications (3)

• Anderson BM, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. A clinical frailty scale obtained from MDT discussion performs poorly in assessing frailty in haemodialysis recipients. BMC Nephrol. 2023 Mar 30;24(1):80. doi: 10.1186/s12882-023-03126-0.

  PMID: 36997856 DERIVED

• Anderson BM, Wilson DV, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. Ultrasound quadriceps muscle thickness is variably associated with frailty in haemodialysis recipients. BMC Nephrol. 2023 Jan 18;24(1):16. doi: 10.1186/s12882-022-03043-8.

  PMID: 36653750 DERIVED

• Anderson BM, Dutton M, Day E, Jackson TA, Ferro CJ, Sharif A. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials. 2018 Aug 24;19(1):457. doi: 10.1186/s13063-018-2842-x.

  PMID: 30143028 DERIVED

MeSH Terms

Conditions

Malnutrition; Motor Activity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Design

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

Study Record Dates

• First Submitted: February 25, 2017
• First Posted: March 6, 2017
• Study Start: December 1, 2017
• Primary Completion: June 15, 2019
• Study Completion: August 1, 2025
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)