Frailty Intervention Trial in End-Stage Patients on Dialysis (FITNESS)
Frailty Intervention Trial in End-Stage Patients on Dialysis: A Feasibility Study
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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West Midlands
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Birmingham, West Midlands, 영국, B15 2WB
- University Hospitals Birmingham NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- On hemodialysis
Exclusion Criteria:
- Inability to give consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 컨트롤 암
치료의 표준
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활성 비교기: Multi-disciplinary intervention arm
Multi-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of frailty intervention study in haemodialysis patients
기간: 6-months
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Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients
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6-months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in frailty status
기간: 6-months
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Change in frailty score between baseline and end of study
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6-months
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Mortality
기간: 6-months
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Difference in mortality episodes between randomised arms
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6-months
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Hospitalisation
기간: 6-months
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Difference in episodes of hospitalisation between randomised arms
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6-months
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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