Quality of Life in Patients Transitioning to Home or In-Center Dialysis (QUALIFY CKD-to-HOME)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

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;

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients followed in advanced CKD clinic;

eGFR ≤12 mL/min/1.73m2 96;

Understand English or French.

Disqualifiers

Orientation toward conservative treatment;

Planned kidney transplantation < 6 months;

Unable to provide consent due to severe cognitive or psychiatric disease;

Previous treatment with dialysis > 3 month;

Trial population

Adults followed in advanced chronic kidney disease clinics recruited from 7 centers across Canada

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Home dialysis or In-Center dialysis

    Other intervention

    Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or in-center dialysis (hemodialysis)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Home dialysis modality1 intervention
Group B: In-center dialysis modality1 intervention

Trial outcomes

Primary outcomes

1

Change in Kidney Disease Quality of Life - 36

Patients Scale from 0-100 (0 = poor, 100 = excellent).

Time frame
From study inclusion until 12-months after dialysis start.

Secondary outcomes

1

Change in Fried Frailty phenotype

5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail.

Time frame
From study inclusion until 12-months after dialysis start.
2

Change in Clinical Frailty Scale

Scale 1 (very fit) to 9 (terminally ill)

Time frame
From study inclusion until 12-months after dialysis start
3

Change in Hospital Anxiety and Depression

14 items scale (7 anxiety, 7 depression) with score \>8 as cut-off for increased risk of depression and anxiety.

Time frame
From study inclusion until 12-months after dialysis start
4

Change in Fatigue

3 items questionnaire to assess fatigue and energy.

Time frame
From study inclusion until 12-months after dialysis start

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

The Kidney Foundation of Canada

Collaborator