Patients Reported OutcomesFSWIFT-PILOTNCT05154708
Impact of the Routine Collection of Symptoms on Quality of Life in Dialysis Patients
An observational study of Patients Reported Outcomes, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Chronic kidney disease (CKD) affects 85,000 people in France. Medical care for this disease represents 2% of the Health Insurance budget. Patients on dialysis frequently experience severe or overwhelming symptoms which contributes to poor health related quality of life (HRQoL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patients Reported Outcomes
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2022to 22 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * For the first part * Patients of both sexes, of different ages and treated by dialysis (hemodialysis and peritoneal dialysis) in different structures (heavy center, medicalized dialysis unit, self-dialysis, home). * Health professionals: nephrologist, health executive, dialysis nurse and nurse coordinator (IPA advanced practice nurse), nursing assistants. * For the second part * Adult patients, volunteers and dialyzed in one of the participating centers: the two heavy centers of the CHRU of Nancy and Nîmes and the off-center dialysis units of ALTIR, * For the pilot phase, we plan to include between 50 and 60 patients (10 per heavy center, 15 in MDU, 15 in AD and 15 at home) Translated with www.DeepL.com/Translator (free version)
Who may be able to join
- For the focus group phase:
- Patients
- Adult patients (≥ 18 years of age), volunteers with end-stage renal disease (ESRD) treated by dialysis in the study centers
- Individuals who have received complete information on the organization of the research and who have not objected to their participation and to the use of their data
- Person with internet access and a computer tool such as a tablet, computer or smartphone
- Health professionals - Volunteer healthcare professionals in the participating departments (CHRU Nancy, ALTIR, CHU Nîmes) with at least 3 months experience in a dialysis department
Show all 13Show fewer
- For the test phase of symptom collection in dialysis services:
- Adult patients (≥ 18 years of age), volunteers with end-stage chronic kidney disease (ESRD) treated with dialysis for at least 3 months in the study participating centers
- Person who has received full information on the organization of the research and has not objected to his or her participation and to the use of his or her data
- Patient able to answer a self-questionnaire
- Person with internet access and a computer tool such as a tablet, computer or smartphone
- Person able to use a computer tool such as a tablet or smartphone
- Person affiliated to a social security system
Who cannot join
- The non-inclusion criteria for the focus group phase are as follows :
- Patients
- Non-dialysis patient
- Dialysis patient in retreat at the facility
- Patient dialyzed for less than 3 months
- Non-voluntary patient
Show all 18Show fewer
- Minor patient
- Patient who does not speak French
- Person placed under judicial protection, guardianship or curatorship
- Health Professionals
- Non-voluntary health professional
- The non-inclusion criteria for the test phase of the collection are as follows:
- Non-dialysis patient
- Dialysis patient in retreat at the facility
- Patient dialyzed for less than 3 months
- Non-voluntary patient
- Minor patient
- Person placed under court protection, guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact on the Quality of Life of Dialysis Patients of the Routine Collection of Symptoms by the Patients Themselves, With Feedback to the Dialysis Team - Pilot Study
Chronic kidney disease (CKD) affects 85,000 people in France. Medical care for this disease represents 2% of the Health Insurance budget.
Patients on dialysis frequently experience severe or overwhelming symptoms which contributes to poor health related quality of life (HRQoL). However, taking into account the measurement of the patients' symptoms by the patients themselves would allow to improve their HRQoL by putting more emphasis on the results that matter the most to the patients. It would also improve information and decision-making between nephrology care team and patients.
Read more
Systematic use of patients reported outcomes measures (PROMs) is not widely used due to a number of barriers including logistics and feasibility.
How will the F-SWIFT Pilot project address the barriers associated with PROMs? By choosing short questionnaires to complete By providing feedback on the severity of symptoms to the dialysis team and to patients By making links to good practice recommendations included in the feedback Allowing electronic collection of PROMs The research question therefore asks whether regular symptom monitoring with feedback to dialysis staff improves dialysis patient's outcomes? To do this, a pilot study must be carried out with the following main objectives Test the feasibility of integrating electronic measurements of PROMs with feedback to the dialysis team.
Three centers are participating in this pilot study:
- The nephrology department of the Nancy CHRU
- The Lorraine Association for the Treatment of Renal Insufficiency (ALTIR)
- The nephrology department of the Nîmes University Hospital
The project will take place in 2 phases :
Phase 1 To identify the needs and expectations of patients and health professionals in relation to a systematic electronic measurement of symptoms made by the patients themselves.
Focus groups (interviews) will be conducted with patients (n=15) and healthcare professionals (n=15).
Phase 2 (n=50-60 patients) To develop and test an electronic PROMs system allowing
- Collect patients' symptoms
- Identify patients with severe symptoms
- Alert the dialysis team in case of severe symptoms
- Suggest appropriate management strategies
Read the detailed description
Patients reported outcomes (PROs) are defined as any measure of a patient's health status reported directly by the patient, without interpretation by health care professionals or others. It is how the patient feels about their health condition or treatment. Although assessing patients' well-being and managing their symptoms are the foundations of clinical care, the care patients receive often does not meet their needs. For example, healthcare professionals are often unaware of the presence and severity of their patients' symptoms. The integration of PROs into clinical trials, clinical care, and quality of care assessment stems from the need to place greater emphasis on the outcomes that matter most to patients.
To date, primary clinical trial endpoints and efficacy metrics in nephrology have been dominated by objective biochemical and process measures (percentage of patients with arteriovenous fistula). These measures fail to reflect what constitutes a good outcome from the patient's perspective, and ultimately there is often very little information about how treatments or any other interventions affect the patient's experience A growing number of studies report a high frequency of symptoms in adult dialysis patients. Patients frequently present with signs of severe pain, fatigue, nausea, cramping, itching, sleep disturbance, and depression, which are strongly associated with poor quality of life. More than half of patients experience fatigue, pruritus (relentless itching), and constipation despite available effective treatments.
In nephrology, studies have focused on survival or biomarker studies and very little on interventions to improve what was a priority for patients, i.e., treating their symptoms and improving their quality of life.
Numerous experiments have been conducted in other fields such as oncology. These studies have shown a real benefit of taking into account measures of perceived health on improving symptom management, treatment side effects and patient survival. Patients for whom regular perceived health follow-up with feedback to oncologists is implemented have a better survival than with traditional follow-up. This is mainly explained by earlier identification and management of symptoms (preventing or reducing the occurrence of downstream adverse events) or side effects of chemotherapy (allowing better tolerance and adherence to the full chemotherapy regimen).
Patients with end-stage renal disease (ESRD) treated with dialysis have poorer survival than patients with certain cancers and a particularly degraded quality of life. Symptoms reported by dialysis patients are often underestimated or even unrecognized by the dialysis team for a variety of reasons. Therefore, it seems possible to improve patient management, outcome, and quality of life through better consideration of symptoms provided the dialysis team is aware of them.
Many questions are still open. Which PRO to measure? How should it be measured? How to store and use the data? How to interpret the results? How can they be integrated with other measures in patient management and treatment decisions? The impact of routine PRO measurements is controversial, especially because of methodological biases in the various studies.
A clinical trial will be set up and nested in the national RIEN registry, entitled F-SWIFT (French-Symptom monitoring WIth Feedback Trial) to improve symptom management in order to address the unmet needs of dialysis CKD patients and improve their quality of life.
The research question posed is whether regular self-reported symptom monitoring with immediate feedback and management recommendations to the dialysis team improves the outcome of dialysis patients.
The F-SWIFT study is the French side of the Australian SWIFT study which has obtained funding and started in 2019.
irst, some technical and logistical feasibility questions need to be answered to adapt the SWIFT study to the French context. Indeed, to date, the PRO measurement is not a routine measurement in dialysis facilities. It therefore seems important to approach patients and professionals to explore their expectations and needs in terms of integrating PRO as a routine management indicator. The first phase is therefore the realization of a pilot study, which is the subject of this protocol.
- Conditions
- Patients Reported Outcomes
- Keywords
- symptoms, Patients reported outcomes, dialysis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group - Phase 1 | 15 to 30 patients are expected in Phase 1 for the identification of needs and expectations in relation to a systematic electronic assessment of symptoms by the patients themselves | |
| Health Professionals Group - Phase 1 | 15 to 30 healthcare professionals are expected to participate in Phase 1 regarding the identification of needs and expectations in relation to a systematic electronic assessment of symptoms by the patients themselves | |
| Patient Group - Phase 2 | 50 à 60 patients were expected to test a systematic electronic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of integrating electronic measurements of self-perceived symptoms with feedback to the dialysis team.
Feasability will be assessed through interviews with patients and health professionals. These interviews will help to identify the elements (interest in the measurement of symptoms by the patients themselves, type of symptoms to be collected, time of measurement, frequency of repetition of the measurement, alert threshold, management of alerts, management of reminders, recommendations for management, etc.) that will guarantee good acceptability of the integration of these measures.
The feasibility will be apprehended by a test phase of the measurement of the symptoms perceived by the patients in real situation using a questionnaire given to the patients and the health professionals.
Measured: 11 months
Secondary outcomes (2)
Results of the focus groups with patients and health professionals
Identify the needs and expectations of patients and health care professionals with respect to a systematic electronic assessment of symptoms by patients themselves
Measured: 2 months
Creation of the electronic symptom collection tool, implementation of links with the REIN registry, systems for managing reminders, alerts, reporting and referrals to management recommendations
Develop the IT tool and interface allowing :
- the link with DIADEM* (secure connection, identity vigilance, integration of the perceived health measure in the registry),
- the collection of symptoms,
- identification of patients with severe symptoms,
- alerting the dialysis team in case of severe symptoms,
- the concomitant proposal of adapted management strategies
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start27 Jan 2022
- Primary completion13 Nov 2023
- Study completion22 Feb 2024
Why it stopped: Patient recruitment for the second phase of the pilot study was too late. There is enough information to meet the study objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Patients Reported OutcomesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine, Association France REIN
- Responsible party
- Principal investigator, Carole AYAV, Central Hospital, Nancy, France
- Investigators
- Luc FRIMAT, Principal investigator, CHRU de NancyOlivier Moranne, Principal investigator, Centre Hospitalier Universitaire de NīmesNelly CASTIN, Principal investigator, ALTIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154708
- Sponsor's protocol ID
- 2021-A00776-35
- Acronym
- FSWIFT-PILOT
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8.
PubMed 17702730U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79.
PubMed 17034633Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O'Donoghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin DE, Tentori F, Agar J, Polkinghorne KR, Gallagher M, Kerr PG, McDonald SP, Howard K, Howell M, Craig JC; Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative. Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. Am J Kidney Dis. 2017 Oct;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029. Epub 2017 Feb 24.
PubMed 28238554Sautenet B, Tong A, Williams G, Hemmelgarn BR, Manns B, Wheeler DC, Tugwell P, van Biesen W, Winkelmayer WC, Crowe S, Harris T, Evangelidis N, Hawley CM, Pollock C, Johnson DW, Polkinghorne KR, Howard K, Gallagher MP, Kerr PG, McDonald SP, Ju A, Craig JC. Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review. Am J Kidney Dis. 2018 Jul;72(1):62-74. doi: 10.1053/j.ajkd.2017.11.010. Epub 2018 Feb 21.
PubMed 29475768Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.
PubMed 20303025Davison SN, Jhangri GS. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage. 2005 Nov;30(5):465-73. doi: 10.1016/j.jpainsymman.2005.05.013.
PubMed 16310620Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.
PubMed 17200048Tong A, Crowe S, Chando S, Cass A, Chadban SJ, Chapman JR, Gallagher M, Hawley CM, Hill S, Howard K, Johnson DW, Kerr PG, McKenzie A, Parker D, Perkovic V, Polkinghorne KR, Pollock C, Strippoli GF, Tugwell P, Walker RG, Webster AC, Wong G, Craig JC. Research Priorities in CKD: Report of a National Workshop Conducted in Australia. Am J Kidney Dis. 2015 Aug;66(2):212-22. doi: 10.1053/j.ajkd.2015.02.341. Epub 2015 May 2.
PubMed 25943716Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.
PubMed 18175207Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
PubMed 28586821Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.
PubMed 30667494Naylor KL, Kim SJ, McArthur E, Garg AX, McCallum MK, Knoll GA. Mortality in Incident Maintenance Dialysis Patients Versus Incident Solid Organ Cancer Patients: A Population-Based Cohort. Am J Kidney Dis. 2019 Jun;73(6):765-776. doi: 10.1053/j.ajkd.2018.12.011. Epub 2019 Feb 6.
PubMed 30738630
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on the Quality of Life of Dialysis Patients of the Routine Collection of Symptoms by the Patients Themselves, With Feedback to the Dialysis Team - Pilot Study
- ClinicalTrials.gov ID
- NCT05154708
- Acronym / sponsor ID
- FSWIFT-PILOT / 2021-A00776-35
- Conditions
- Patients Reported Outcomes
- Keywords
- symptoms, Patients reported outcomes, dialysis patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient recruitment for the second phase of the pilot study was too late. There is enough information to meet the study objectives.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine, Association France REIN
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD) affects 85,000 people in France. Medical care for this disease represents 2% of the Health Insurance budget.
Patients on dialysis frequently experience severe or overwhelming symptoms which contributes to poor health related quality of life (HRQoL). However, taking into account the measurement of the patients' symptoms by the patients themselves would allow to improve their HRQoL by putting more emphasis on the results that matter the most to the patients. It would also improve information and decision-making between nephrology care team and patients.
Systematic use of patients reported outcomes measures (PROMs) is not widely used due to a number of barriers including logistics and feasibility.
How will the F-SWIFT Pilot project address the barriers associated with PROMs? By choosing short questionnaires to complete By providing feedback on the severity of symptoms to the dialysis team and to patients By making links to good practice recommendations included in the feedback Allowing electronic collection of PROMs The research question therefore asks whether regular symptom monitoring with feedback to dialysis staff improves dialysis patient's outcomes? To do this, a pilot study must be carried out with the following main objectives Test the feasibility of integrating electronic measurements of PROMs with feedback to the dialysis team.
Three centers are participating in this pilot study:
- The nephrology department of the Nancy CHRU
- The Lorraine Association for the Treatment of Renal Insufficiency (ALTIR)
- The nephrology department of the Nîmes University Hospital
The project will take place in 2 phases :
Phase 1 To identify the needs and expectations of patients and health professionals in relation to a systematic electronic measurement of symptoms made by the patients themselves.
Focus groups (interviews) will be conducted with patients (n=15) and healthcare professionals (n=15).
Phase 2 (n=50-60 patients) To develop and test an electronic PROMs system allowing
- Collect patients' symptoms
- Identify patients with severe symptoms
- Alert the dialysis team in case of severe symptoms
- Suggest appropriate management strategies
Detailed description
Patients reported outcomes (PROs) are defined as any measure of a patient's health status reported directly by the patient, without interpretation by health care professionals or others. It is how the patient feels about their health condition or treatment. Although assessing patients' well-being and managing their symptoms are the foundations of clinical care, the care patients receive often does not meet their needs. For example, healthcare professionals are often unaware of the presence and severity of their patients' symptoms. The integration of PROs into clinical trials, clinical care, and quality of care assessment stems from the need to place greater emphasis on the outcomes that matter most to patients.
To date, primary clinical trial endpoints and efficacy metrics in nephrology have been dominated by objective biochemical and process measures (percentage of patients with arteriovenous fistula). These measures fail to reflect what constitutes a good outcome from the patient's perspective, and ultimately there is often very little information about how treatments or any other interventions affect the patient's experience A growing number of studies report a high frequency of symptoms in adult dialysis patients. Patients frequently present with signs of severe pain, fatigue, nausea, cramping, itching, sleep disturbance, and depression, which are strongly associated with poor quality of life. More than half of patients experience fatigue, pruritus (relentless itching), and constipation despite available effective treatments.
In nephrology, studies have focused on survival or biomarker studies and very little on interventions to improve what was a priority for patients, i.e., treating their symptoms and improving their quality of life.
Numerous experiments have been conducted in other fields such as oncology. These studies have shown a real benefit of taking into account measures of perceived health on improving symptom management, treatment side effects and patient survival. Patients for whom regular perceived health follow-up with feedback to oncologists is implemented have a better survival than with traditional follow-up. This is mainly explained by earlier identification and management of symptoms (preventing or reducing the occurrence of downstream adverse events) or side effects of chemotherapy (allowing better tolerance and adherence to the full chemotherapy regimen).
Patients with end-stage renal disease (ESRD) treated with dialysis have poorer survival than patients with certain cancers and a particularly degraded quality of life. Symptoms reported by dialysis patients are often underestimated or even unrecognized by the dialysis team for a variety of reasons. Therefore, it seems possible to improve patient management, outcome, and quality of life through better consideration of symptoms provided the dialysis team is aware of them.
Many questions are still open. Which PRO to measure? How should it be measured? How to store and use the data? How to interpret the results? How can they be integrated with other measures in patient management and treatment decisions? The impact of routine PRO measurements is controversial, especially because of methodological biases in the various studies.
A clinical trial will be set up and nested in the national RIEN registry, entitled F-SWIFT (French-Symptom monitoring WIth Feedback Trial) to improve symptom management in order to address the unmet needs of dialysis CKD patients and improve their quality of life.
The research question posed is whether regular self-reported symptom monitoring with immediate feedback and management recommendations to the dialysis team improves the outcome of dialysis patients.
The F-SWIFT study is the French side of the Australian SWIFT study which has obtained funding and started in 2019.
irst, some technical and logistical feasibility questions need to be answered to adapt the SWIFT study to the French context. Indeed, to date, the PRO measurement is not a routine measurement in dialysis facilities. It therefore seems important to approach patients and professionals to explore their expectations and needs in terms of integrating PRO as a routine management indicator. The first phase is therefore the realization of a pilot study, which is the subject of this protocol.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient Group - Phase 1 | – | –15 to 30 patients are expected in Phase 1 for the identification of needs and expectations in relation to a systematic electronic assessment of symptoms by the patients themselves |
| Health Professionals Group - Phase 1 | – | –15 to 30 healthcare professionals are expected to participate in Phase 1 regarding the identification of needs and expectations in relation to a systematic electronic assessment of symptoms by the patients themselves |
| Patient Group - Phase 2 | – | –50 à 60 patients were expected to test a systematic electronic assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * For the first part * Patients of both sexes, of different ages and treated by dialysis (hemodialysis and peritoneal dialysis) in different structures (heavy center, medicalized dialysis unit, self-dialysis, home). * Health professionals: nephrologist, health executive, dialysis nurse and nurse coordinator (IPA advanced practice nurse), nursing assistants. * For the second part * Adult patients, volunteers and dialyzed in one of the participating centers: the two heavy centers of the CHRU of Nancy and Nîmes and the off-center dialysis units of ALTIR, * For the pilot phase, we plan to include between 50 and 60 patients (10 per heavy center, 15 in MDU, 15 in AD and 15 at home) Translated with www.DeepL.com/Translator (free version)
Key inclusion criteria (13 listed)
- For the focus group phase:
- Patients
- Adult patients (≥ 18 years of age), volunteers with end-stage renal disease (ESRD) treated by dialysis in the study centers
- Individuals who have received complete information on the organization of the research and who have not objected to their participation and to the use of their data
- Person with internet access and a computer tool such as a tablet, computer or smartphone
Key exclusion criteria (18 listed)
- Patients
- Non-dialysis patient
- Dialysis patient in retreat at the facility
- Patient dialyzed for less than 3 months
- Non-voluntary patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The feasibility of integrating electronic measurements of self-perceived symptoms with feedback to the dialysis team.
Time frame: 11 months
Feasability will be assessed through interviews with patients and health professionals. These interviews will help to identify the elements (interest in the measurement of symptoms by the patients themselves, type of symptoms to be collected, time of measurement, frequency of repetition of the measurement, alert threshold, management of alerts, management of reminders, recommendations for management, etc.) that will guarantee good acceptability of the integration of these measures. The feasibility will be apprehended by a test phase of the measurement of the symptoms perceived by the patients in real situation using a questionnaire given to the patients and the health professionals.
2 secondary outcomes
Results of the focus groups with patients and health professionals
Time frame: 2 months
Creation of the electronic symptom collection tool, implementation of links with the REIN registry, systems for managing reminders, alerts, reporting and referrals to management recommendations
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Patient recruitment for the second phase of the pilot study was too late. There is enough information to meet the study objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 17702730Weisbord SD, Fried LF, Mor MK, Resnick AL, Unruh ML, Palevsky PM, Levenson DJ, Cooksey SH, Fine MJ, Kimmel PL, Arnold RM. Renal provider recognition of symptoms in patients on maintenance hemodialysis. Clin J Am Soc Nephrol. 2007 Sep;2(5):960-7. doi: 10.2215/CJN.00990207. Epub 2007 Aug 8.
- Results publication: PubMed 17034633U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. doi: 10.1186/1477-7525-4-79.
- Results publication: PubMed 28238554Evangelidis N, Tong A, Manns B, Hemmelgarn B, Wheeler DC, Tugwell P, Crowe S, Harris T, Van Biesen W, Winkelmayer WC, Sautenet B, O'Donoghue D, Tam-Tham H, Youssouf S, Mandayam S, Ju A, Hawley C, Pollock C, Harris DC, Johnson DW, Rifkin DE, Tentori F, Agar J, Polkinghorne KR, Gallagher M, Kerr PG, McDonald SP, Howard K, Howell M, Craig JC; Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative. Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey. Am J Kidney Dis. 2017 Oct;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029. Epub 2017 Feb 24.
- Results publication: PubMed 29475768Sautenet B, Tong A, Williams G, Hemmelgarn BR, Manns B, Wheeler DC, Tugwell P, van Biesen W, Winkelmayer WC, Crowe S, Harris T, Evangelidis N, Hawley CM, Pollock C, Johnson DW, Polkinghorne KR, Howard K, Gallagher MP, Kerr PG, McDonald SP, Ju A, Craig JC. Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review. Am J Kidney Dis. 2018 Jul;72(1):62-74. doi: 10.1053/j.ajkd.2017.11.010. Epub 2018 Feb 21.
- Results publication: PubMed 20303025Davison SN, Jhangri GS. Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients. J Pain Symptom Manage. 2010 Mar;39(3):477-85. doi: 10.1016/j.jpainsymman.2009.08.008.
- Results publication: PubMed 16310620Davison SN, Jhangri GS. The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients. J Pain Symptom Manage. 2005 Nov;30(5):465-73. doi: 10.1016/j.jpainsymman.2005.05.013.
- Results publication: PubMed 17200048Murtagh FE, Addington-Hall J, Higginson IJ. The prevalence of symptoms in end-stage renal disease: a systematic review. Adv Chronic Kidney Dis. 2007 Jan;14(1):82-99. doi: 10.1053/j.ackd.2006.10.001.
- Results publication: PubMed 25943716Tong A, Crowe S, Chando S, Cass A, Chadban SJ, Chapman JR, Gallagher M, Hawley CM, Hill S, Howard K, Johnson DW, Kerr PG, McKenzie A, Parker D, Perkovic V, Polkinghorne KR, Pollock C, Strippoli GF, Tugwell P, Walker RG, Webster AC, Wong G, Craig JC. Research Priorities in CKD: Report of a National Workshop Conducted in Australia. Am J Kidney Dis. 2015 Aug;66(2):212-22. doi: 10.1053/j.ajkd.2015.02.341. Epub 2015 May 2.
- Results publication: PubMed 18175207Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.
- Results publication: PubMed 28586821Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
- Results publication: PubMed 30667494Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085.
- Results publication: PubMed 30738630Naylor KL, Kim SJ, McArthur E, Garg AX, McCallum MK, Knoll GA. Mortality in Incident Maintenance Dialysis Patients Versus Incident Solid Organ Cancer Patients: A Population-Based Cohort. Am J Kidney Dis. 2019 Jun;73(6):765-776. doi: 10.1053/j.ajkd.2018.12.011. Epub 2019 Feb 6.
- Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidanceLink provided by the sponsor.
- Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi SurveyLink provided by the sponsor.
- Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic ReviewLink provided by the sponsor.
- Impact of pain and symptom burden on the health-related quality of life of hemodialysis patientsLink provided by the sponsor.
- The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patientsLink provided by the sponsor.
- The prevalence of symptoms in end-stage renal disease: a systematic reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc FRIMAT principal investigator
CHRU de Nancy
Olivier Moranne principal investigator
Centre Hospitalier Universitaire de Nīmes
Nelly CASTIN principal investigator
ALTIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Reported Outcomes, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient recruitment for the second phase of the pilot study was too late. There is enough information to meet the study objectives.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of integrating electronic measurements of self-perceived symptoms with feedback to the dialysis team. (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05154708, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.