Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458322
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Quality of Life in Patients Transitioning to Home or In-Center Dialysis QUALIFY CKD-to-HOME
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
Prospective Changes in Quality of Life and Frailty in Chronic Kidney Disease Patients Transitioning to Home Versus In-Center Dialysis QUALIFY CKD-to-HOME Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate quality of life QoL and frailty trajectories from advanced chronic kidney disease CKD to after dialysis initiation specifically comparing patients choosing home dialysis and in-center hemodialysis
The main questions it aims to answer are
1 What is the trajectory of QoL in patients transitioning from advanced CKD to dialysis up to 12 months after initiation and how does these changes differ for patients oriented towards home dialysis and in-center hemodialysis
2 Is the development of frailty after dialysis initiation less likely in patient pursuing home dialysis
3 What is the variation in other PROMs and health outcomes fatigue anxiety depression general assessment cognitive function form advanced CKD to the first 12 months after dialysis initiation
4 What are the predictors of severe decline in QoL frailty and other important health outcomes fatigue cognition anxiety depression during CKD G5 follow-up and after 12 months post dialysis initiation
Participants will be ask to
Answer some questions and complete questionnaires each 3 months
Do a a grip test and a walking test each 6 months to evaluate their frailty
The main questions it aims to answer are
1 What is the trajectory of QoL in patients transitioning from advanced CKD to dialysis up to 12 months after initiation and how does these changes differ for patients oriented towards home dialysis and in-center hemodialysis
2 Is the development of frailty after dialysis initiation less likely in patient pursuing home dialysis
3 What is the variation in other PROMs and health outcomes fatigue anxiety depression general assessment cognitive function form advanced CKD to the first 12 months after dialysis initiation
4 What are the predictors of severe decline in QoL frailty and other important health outcomes fatigue cognition anxiety depression during CKD G5 follow-up and after 12 months post dialysis initiation
Participants will be ask to
Answer some questions and complete questionnaires each 3 months
Do a a grip test and a walking test each 6 months to evaluate their frailty
Detailed Description:
Background Home dialysis is encouraged as the preferred therapy for people starting dialysis across Canada with increased use of peritoneal dialysis PD and home hemodialysis HHD for patients with higher comorbidity burden Dialysis modality selection is primarily a patient-centered choice Modality selection should be mostly based on lifestyle and personal values Despite the recognition of this patient-centered decision most dialysis modality studies are based on mortality hospitalization and socioeconomic factors There is a paucity of data to best inform patients of the expected changes in patient-reported outcomes measures PROMs such as quality of life QoL and the progression of their frailty status after dialysis initiation
ObjectiveOur study will fill this knowledge gap and evaluate QoL and frailty trajectories from advanced chronic kidney disease CKD to after dialysis initiation specifically comparing patients choosing home dialysis and in-center hemodialysis ICHD
Design and Research Plan Qualify CKD-to-Home is a prospective cohort study in 7 centers across Canada with active patient-partner engagement It is expected that around 200 patients will participate Effort will be made to keep the ration of patients oriented towards home dialysis versus in-center at 12 or less
Every 3 months participants will be followed from estimated glomerular filtration rate eGFR 12 mLmin173m2 and up to 12 months after dialysis start They will be ask to complete questionnaires as the Kidney Disease Quality of Life KDQOL-36 Quality of Life the Hospital Anxiety and Depression Scale HADS the Standardized outcomes in Nephrology SONG-HD Fatigue the Medical Outcome Study- Social Support Survey MOS-SSS Social Support the Montreal Cognitive assessment MoCa Cognitive Function the Clinical Frailty Scale CFS the Fried Frailty Phenotype FP and the Gender-Related Variable for Health Research questionnaire GVHR
Analyse Descriptive statistics will be used to report baseline characteristics for all patients The KDQOL-36 components and domains CFS FI HADS SONG Fatigue instrument feeling thermometer and MOCA will be treated as continuous measures Relationship between baseline scores will be assessed using Spearman correlation Within patient changes in QoL continuous frailty measures CFS FI fatigue depression anxiety and general health will be described using generalized linear mixed effects models for repeated measures over time Within patient changes in the proportion of patients classified as frail vs non-frail pre-frail using the FP with dichotomization will be analyzed in generalized linear mixed models with logistic links for binary repeated measures outcomes nested within centers Missing data will be managed using multiple imputation by chained equations prior to proposed analyses
Future directions This study will help inform patients with advanced CKD on the trajectory of important patient-centered outcomes after dialysis initiation with different dialysis modality We will use data from this study to build on a mixed-methods approach with qualitative interviews of patients caregiver to extend the reach of our understanding on PROMs QoL and frailty changes during the CKD to dialysis transition Finally our results will guide stakeholders in the development of interventions that will mitigate risk of adverse outcomes for home dialysis patients at increased risk as identified in our study
ObjectiveOur study will fill this knowledge gap and evaluate QoL and frailty trajectories from advanced chronic kidney disease CKD to after dialysis initiation specifically comparing patients choosing home dialysis and in-center hemodialysis ICHD
Design and Research Plan Qualify CKD-to-Home is a prospective cohort study in 7 centers across Canada with active patient-partner engagement It is expected that around 200 patients will participate Effort will be made to keep the ration of patients oriented towards home dialysis versus in-center at 12 or less
Every 3 months participants will be followed from estimated glomerular filtration rate eGFR 12 mLmin173m2 and up to 12 months after dialysis start They will be ask to complete questionnaires as the Kidney Disease Quality of Life KDQOL-36 Quality of Life the Hospital Anxiety and Depression Scale HADS the Standardized outcomes in Nephrology SONG-HD Fatigue the Medical Outcome Study- Social Support Survey MOS-SSS Social Support the Montreal Cognitive assessment MoCa Cognitive Function the Clinical Frailty Scale CFS the Fried Frailty Phenotype FP and the Gender-Related Variable for Health Research questionnaire GVHR
Analyse Descriptive statistics will be used to report baseline characteristics for all patients The KDQOL-36 components and domains CFS FI HADS SONG Fatigue instrument feeling thermometer and MOCA will be treated as continuous measures Relationship between baseline scores will be assessed using Spearman correlation Within patient changes in QoL continuous frailty measures CFS FI fatigue depression anxiety and general health will be described using generalized linear mixed effects models for repeated measures over time Within patient changes in the proportion of patients classified as frail vs non-frail pre-frail using the FP with dichotomization will be analyzed in generalized linear mixed models with logistic links for binary repeated measures outcomes nested within centers Missing data will be managed using multiple imputation by chained equations prior to proposed analyses
Future directions This study will help inform patients with advanced CKD on the trajectory of important patient-centered outcomes after dialysis initiation with different dialysis modality We will use data from this study to build on a mixed-methods approach with qualitative interviews of patients caregiver to extend the reach of our understanding on PROMs QoL and frailty changes during the CKD to dialysis transition Finally our results will guide stakeholders in the development of interventions that will mitigate risk of adverse outcomes for home dialysis patients at increased risk as identified in our study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None