Does NIGHT-time dialysis improve quality of LIFE?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Participants will be randomised to either: 1. Intervention arm where participants will receive 6 ‐ 8 h of in‐centre haemodialysis delivered overnight, 3 times per week for 6 months. 2. Standard care arm where participants will receive 3.5 ‐ 5 h of in‐centre haemodialysis, 3 times per week during the day for 6 months. Randomisation: Participants will be randomised to an intervention group immediately after consent is taken using a ratio of 3 allocations to daytime haemodialysis to 4 allocations to extended hours nocturnal dialysis (1.33:1 ratio). Randomisation will be performed via a web‐based system (Sealed Envelope). The unequal allocation in favour of the intervention will account for the anticipated 25% non‐adherence rate in the intervention group (patients who start nocturnal dialysis but revert to daytime dialysis within the first 2‐weeks. Internal pilot: During the first 12 months of the recruitment period the feasibility of completing the study in the desired time frame will be assessed using an internal pilot. Based on investigator experience, the following targets will be set: 1. Recruit a minimum of 2 new units per quarter; 8 units initiated at 12‐months 2. Randomise an average of 12 patients per unit in the first quarter (i.e. 6 patients will start in‐centre nocturnal dialysis); 96 participants randomised at 12‐months 3. Experience a maximum 25% drop out rate in the first two weeks of starting in patients randomised to in‐centre nocturnal dialysis; participant drop out in first 2 weeks of nocturnal dialysis is <25% at 12‐month 4. Encounter a dropout rate of no more than 15% across the two study arms as a result of CONDITION: Haemodialysis, renal failure ; Urological and Genital Diseases ; Haemodialysis (or haemodiafiltration), kidney dialysis, kidney failure, renal failure PRIMARY OUTCOME: Quality of life measured using the composite score from the Kidney Disease Quality of Life tool (KDQoL) at 6 months INCLUSION CRITERIA: 1. Patients established on haemodialysis for =3 months (i.e. prevalent dialysis patients) 2. Aged =18 years 3. Able to give informed consent 4. Able to participate fully in the interventions and follow‐up procedures SECONDARY OUTCOME: ; 1. Quality of life measured using the Kidney Disease Quality of Life tool (KDQoL) at 1 and 3 months; 2. Additional Patient Reported Outcome Measures assessed at baseline, 1, 3 and 6 months:; 2.1. Health‐related quality of life measured using the EQ‐5D‐5L; 2.2. Levels of fatigue measured using the SONG Haemodialysis Fatigue measure; 2.3. Sleep quality measured using the Pittsburgh Sleep Quality Index; 2.4. Time to recovery after dialysis measured using a simple question on Time to Recovery (TTR) in minutes after dialysis; 3. Safety measures:; 3.1. Residual kidney function measured using urine collection with paired blood samples taken at the time of dialysis to give standard measures of urine volume, urea and creatinine clearance at baseline and 6 months, and serum beta‐2 microglobulin in blood samples taken monthly between baseline and 6 months; 3.2. Vascular access complications that lead to AEs or hospital admission using site records between baseline and 6 months; 3.3. Adverse events using site records of the number and type of adverse events (including mortality, cardiovascular events, hospitalisation and vascular access interventions) collected using Hospital Episode Statistics (HES) and Office of National Statistics (ONS) databases (or regional equivalent) at 3 years follow up; 3.4. Clinical outcomes (cardiovascular events, CVD death, mortality) collected using Hospital Episode Statistics (HES) and Office of National Statistics (ONS) databases (or regional equivalent) at 3 years follow up; 4. Process evaluation measures:; 4.1. Adherence to the intervention and hours on dialysis at 6 months; 4.2. Impact of longer dialysis on the clinical results/dialysis parameters using routinely collected data from dialysis units for required data return to the UK Renal Registry (UKRR) and Scottish Renal Registry (SRR), extracted at 1, 2 and 3 years; 5. Cost‐effectiveness analysis measures:; 5.1. Resource use and expenditure measured using both: a self‐completed health economics questionnaire at baseline and a resource use/expenditure questionnaire and diary at 1, 3, and 6 months from participants; and a staff questionnaire completed by a senior nurse responsible for the haemodialysis unit before and after implementation of the intervention; 5.2. Cost per QALY gained;
Epistemonikos ID: 74edc993f8f7102ee6a089d5943423dc8e6c0dbf
First added on: Oct 16, 2021