Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients, With Results Notification to Teams. A Cluster Randomised Controlled Trial Nested in a National Registry F-SWIFT (French Symptom Monitoring WIth Feedback Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,293
- 试验地点
- 3
- 主要终点
- Health-related quality of life over 12 months, measured by the physical health score of the validated Kidney Disease and Quality of Life™ Short Form (KDQoL-36) questionnaire.
研究概览
简要总结
In France, end-stage renal disease (ESRD) affects almost 170 people per million inhabitants every year, and 92,500 people are treated by dialysis or kidney transplantation (0.14% of the French population).
The treatment of chronic renal failure is extremely costly: 4 billion euros in 2021, i.e. 2% of health insurance expenditure, and an annual cost of 42,000 euros per patient.
The health-related quality of life (HRQoL) of dialysis patients is low, with reports of patients at 40%-60% of full health. In France, there has been a significant decrease in physical (-15.4 points) and mental (-6.9 points) component scores compared with the general population. Dialysis patients often present severe or overwhelming symptoms, which contribute to this poor HRQoL. However, in nephrology, studies have focused on survival and laboratory biomarkers, and very few interventions have been aimed at improving what was a priority for patients, i.e. treating their symptoms and improving their HRQoL. Opportunities to intervene and improve symptom management and overall HRQoL may therefore have been missed.
Ignoring patients' symptoms is an important omission. Of 28 randomized trials in primary care and oncology that measured the impact of communicating patient-reported outcomes to clinicians, 65% showed improved care processes and 47% improved health outcomes. The results of two recent randomized trials in oncology suggest that symptom monitoring can improve HRQoL and overall survival.
There is no evidence for dialysis patients, although therapeutic solutions are available in most cases.
Nephrology teams do not sufficiently recognize the prevalence, severity and negative effects of symptoms in their patients, and patients under-report their symptoms. With systematic symptom screening and automatic transmission of symptoms in the form of alerts, dialysis staff will be able to react and implement routine management to alleviate patients' symptoms.
The F-SWIFT study evaluates the hypothesis that regular symptom monitoring and feedback to hemodialysis patients and their dialysis staff improves patient HRQoL at 18 months.
In addition, the trial aims to determine whether electronic capture of patient-reported outcomes within a national dialysis patient registry is feasible and cost-effective, evaluated using consumption data from the Système National des données de Santé (SNDS) medico-administrative database.
F-SWIFT is the French part of an international project (SWIFT) initiated in Australia in 2021: Australian New Zealand Clinical Trials Registry #ACTRN12620001061921. This French part is funded by Inserm's AAP MESSIDORE 2022.
F-SWIFT is also the continuation of the pilot study n° 2021-A00776-35 accepted by the CPP EST II on 19/10/2021 and financed by the Agence de la Biomédecine (AOR 2021) in the RIPH3 category.
详细描述
F-SWIFT is a large-scale, multi-center, randomized controlled trial (qualitative and quantitative) nested in a national registry.
Indeed, this research project is nested in the REIN (Réseau Epidémiologique et Information en Nephrologie) registry, to which all dialysis units in France have been contributing for over 10 years. All information on the dialysis units and the patients included is taken directly from the register. The field presence of REIN's clinical research officers ensures the quality of the data routinely collected for the registry, and reused in this project.
The F-SWIFT project includes a process analysis to support the transferability of F-SWIFT in the event of proven effectiveness, with a view to large-scale deployment.
Data analysis will be carried out by a biostatistician and Human and Social Sciences engineers from CIC 1433 Epidémiologie Clinique at CHRU Nancy.
In accordance with the third paragraph of article 56 of the French Data Protection Act, the presentation of the results of data processing may under no circumstances allow direct or indirect identification of the persons involved in the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptom collection phase
- •The inclusion criteria for patients are as follows:
- •Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data.
- •Adults aged 18 and over
- •Patients with end-stage renal disease treated by dialysis in participating dialysis units
- •Patients able to answer questionnaires
- •Process evaluation phase
- •The inclusion criteria for healthcare professionals are as follows:
- •Individuals who have received full information on the organization of the research and who have not objected to their participation and to the use of their data.
- •Patients with end-stage renal disease treated by dialysis in participating dialysis units.
- •Doctors and nurses working in the dialysis unit taking part in the study.
排除标准
- •The non-inclusion criteria for patients are as follows:
- •Patients under legal protection, guardianship or curatorship
- •Patient not communicating or unable to give consent
- •Patient not being treated in a dialysis unit participating in the study
- •Patients being treated temporarily in a participating dialysis unit (respite care, vacationers, etc.)
- •Patient with cognitive disorders
- •Patient unable or unwilling to answer questionnaires
- •The non-inclusion criteria for healthcare professionals are as follows:
- •Non-voluntary healthcare professional
- •Healthcare professional not working in the participating facility
研究组 & 干预措施
Control group
Patients in the control group will complete three HRQoL questionnaires every six months via a digital tablet during their dialysis session.
干预措施: No systematic monitoring of symptoms (Other)
Experimental group
Every three months, patients in the experimental group will have their symptoms systematically recorded using the IPOS-Renal questionnaire via a digital tablet during their dialysis session.
干预措施: Systematic monitoring of symptoms (Other)
结局指标
主要结局
Health-related quality of life over 12 months, measured by the physical health score of the validated Kidney Disease and Quality of Life™ Short Form (KDQoL-36) questionnaire.
时间窗: 12 months
KDQoL-36 Short form assesses quality of life over the past 4 weeks. Physical health score ranges from 0=Worst quality of life to 100=Best quality of life
次要结局
- Respondents' perceptions of the impact of the system's implementation and changes in practices(3 months)
- Severity of symptoms measured using the IPOS Renal (Integrated Palliative Outcome Score Renal) questionnaires(18 months)
- 12-month survival measured using REIN registry data(12 months)
- Questionnaire completion rates for different arms and periods.(12 months)
- 12-month survival measured using REIN data(18 months)
- Numbers of care consumption, including hospitalizations, drugs, prescriptions for biological and imaging tests, based on SNDS data.(18 months)
- Incremental cost between intervention and no-intervention groups related to the quality-adjusted life-year differential assessed by the evolution of utility at 12 months measured by the EQD5D-5L questionnaire.(18 months)
- Duration of dialysis measured using REIN registry data.(18 months)
- Frequency of dialysis measured using REIN registry data.(18 months)
- Number of dialysis stops measured using REIN registry data.(18 months)
- Severity of symptoms measured using the SONG fatigue (Stadardised Outcomes in NephroloGy Fatigue) questionnaires(18 months)
研究者
GUILLEMIN Francis, MD
Professor
Central Hospital, Nancy, France