Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-12-23
Brief Title:
Impact on Quality of Life of Symptoms Routine E-monitoring Among Dialysis Patients
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
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
Status:
NOT_YET_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:
F-SWIFT
Brief Summary:
In France end-stage renal disease ESRD affects almost 170 people per million inhabitants every year and 92500 people are treated by dialysis or kidney transplantation 014 of the French population
The treatment of chronic renal failure is extremely costly 4 billion euros in 2021 ie 2 of health insurance expenditure and an annual cost of 42000 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 -154 points and mental -69 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 ie 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 Inserms AAP MESSIDORE 2022
F-SWIFT is also the continuation of the pilot study n 2021-A00776-35 accepted by the CPP EST II on 19102021 and financed by the Agence de la Biomédecine AOR 2021 in the RIPH3 category
The treatment of chronic renal failure is extremely costly 4 billion euros in 2021 ie 2 of health insurance expenditure and an annual cost of 42000 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 -154 points and mental -69 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 ie 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 Inserms AAP MESSIDORE 2022
F-SWIFT is also the continuation of the pilot study n 2021-A00776-35 accepted by the CPP EST II on 19102021 and financed by the Agence de la Biomédecine AOR 2021 in the RIPH3 category
Detailed Description:
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 REINs 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
Experimental group
Quarterly measurement for 18 months of patients symptoms using the IPOS-Renal questionnaire which will be systematically reported to professionals
Measurement every 6 months for 18 months of patients health-related HRQoL using the EQ-5D-5L European Quality of Life 5 Dimensions 5 Level Version KDQoL-36 Kidney Disease and Quality of Life Short Form and SONG-Fatigue Stadardised Outcomes in NephroloGy Fatigue questionnaires
Control group
No systematic symptom monitoring will be organized and patients will receive usual care
Measurement every 6 months for 18 months of health-related HRQoL using the EQ-5D-5L KDQoL-36 and SONG-Fatigue questionnaires
Process evaluation phase
Quantitative component
For all dialysis units included in the experimental arm
The REIN registry will provide data on legal status volume of patients managed treatment options offered The REIN registry will also provide data on patients in these units age sex comorbidity length of time on dialysis and dialysis treatment modality
For patients at inclusion an ad hoc questionnaire will be added on electronic equipment at home which includes the availability and use of a laptop desktop tablet cell phone and broadband internet subscription
Per unit every 3 months loyalty criteria of patients having completed the IPOS-Renal questionnaire and dose criteria cumulative number of completed IPOS-Renal questionnaires will be collected
Based on the reimbursement list provided by the health insurance data extracted from the REIN register linked to the SNDS changes in prescribing practices will be studied prescription of drugs and supportive care in particular dietary psychological and sports care The before-and-after trends will be analyzed one year after the end of the study in the unit remote evaluation since the data are only consolidated at that time
Qualitative component
Three months after the start of the study from among the units in the experimental group meeting the condition without external assistance from the Clinical Research Nurse CRN to collect data five units will be selected following an extreme case sampling 2 with the highest level 1 with a standard level and 2 with the lowest level of intervention application to conduct semi-structured interviews
At this stage the research team will focus on organizational and implementation factors to provide information for the scientific committee which will be responsible for decisions to adapt the F-SWIFT intervention and improve its effectiveness After three months of fine-tuning the intervention the research team will carry out a second wave of qualitative process evaluation to retest the intervention in five other units
Semi-structured individual interviews will therefore be conducted with patients and healthcare professionals nurses and doctors on the basis of a guide developed to gather perceptual data on how contextual characteristics affect the effective implementation and outcomes of the F-SWIFT intervention
Participants in the individual semi-structured interview will receive an e-mail from an engineer in the humanities and social sciences informing them of the date and time of the appointment as well as the connection link if the interview takes place remotely
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 REINs 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
Experimental group
Quarterly measurement for 18 months of patients symptoms using the IPOS-Renal questionnaire which will be systematically reported to professionals
Measurement every 6 months for 18 months of patients health-related HRQoL using the EQ-5D-5L European Quality of Life 5 Dimensions 5 Level Version KDQoL-36 Kidney Disease and Quality of Life Short Form and SONG-Fatigue Stadardised Outcomes in NephroloGy Fatigue questionnaires
Control group
No systematic symptom monitoring will be organized and patients will receive usual care
Measurement every 6 months for 18 months of health-related HRQoL using the EQ-5D-5L KDQoL-36 and SONG-Fatigue questionnaires
Process evaluation phase
Quantitative component
For all dialysis units included in the experimental arm
The REIN registry will provide data on legal status volume of patients managed treatment options offered The REIN registry will also provide data on patients in these units age sex comorbidity length of time on dialysis and dialysis treatment modality
For patients at inclusion an ad hoc questionnaire will be added on electronic equipment at home which includes the availability and use of a laptop desktop tablet cell phone and broadband internet subscription
Per unit every 3 months loyalty criteria of patients having completed the IPOS-Renal questionnaire and dose criteria cumulative number of completed IPOS-Renal questionnaires will be collected
Based on the reimbursement list provided by the health insurance data extracted from the REIN register linked to the SNDS changes in prescribing practices will be studied prescription of drugs and supportive care in particular dietary psychological and sports care The before-and-after trends will be analyzed one year after the end of the study in the unit remote evaluation since the data are only consolidated at that time
Qualitative component
Three months after the start of the study from among the units in the experimental group meeting the condition without external assistance from the Clinical Research Nurse CRN to collect data five units will be selected following an extreme case sampling 2 with the highest level 1 with a standard level and 2 with the lowest level of intervention application to conduct semi-structured interviews
At this stage the research team will focus on organizational and implementation factors to provide information for the scientific committee which will be responsible for decisions to adapt the F-SWIFT intervention and improve its effectiveness After three months of fine-tuning the intervention the research team will carry out a second wave of qualitative process evaluation to retest the intervention in five other units
Semi-structured individual interviews will therefore be conducted with patients and healthcare professionals nurses and doctors on the basis of a guide developed to gather perceptual data on how contextual characteristics affect the effective implementation and outcomes of the F-SWIFT intervention
Participants in the individual semi-structured interview will receive an e-mail from an engineer in the humanities and social sciences informing them of the date and time of the appointment as well as the connection link if the interview takes place remotely
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