Impact of the Routine Collection of Symptoms on Quality of Life in Dialysis Patients
NCT ID: NCT05154708
Last Updated: 2025-02-27
Study Results
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Basic Information
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TERMINATED
65 participants
OBSERVATIONAL
2022-01-27
2024-02-22
Brief Summary
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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
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Detailed Description
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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
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Patient Group - Phase 2
50 à 60 patients were expected to test a systematic electronic assessment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
Patients
* Non-dialysis patient
* Dialysis patient in retreat at the facility
* Patient dialyzed for less than 3 months
* Non-voluntary patient
* Minor patient
* Patient who does not speak French
* Person placed under judicial protection, guardianship or curatorship
Health Professionals
\- Non-voluntary health professional
* 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
18 Years
ALL
Yes
Sponsors
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Agence de La Biomédecine
OTHER_GOV
Association France REIN
UNKNOWN
Central Hospital, Nancy, France
OTHER
Responsible Party
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Carole AYAV
Principal Investigator
Principal Investigators
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Luc FRIMAT
Role: PRINCIPAL_INVESTIGATOR
CHRU de Nancy
Olivier Moranne
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nīmes
Nelly CASTIN
Role: PRINCIPAL_INVESTIGATOR
ALTIR
Locations
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CHRU de Nancy
Vandœuvre-lès-Nancy, , France
Countries
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References
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U.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.
Evangelidis 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.
Sautenet 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.
Davison 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.
Davison 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.
Murtagh 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.
Tong 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.
Valderas 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.
Basch 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.
Denis 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.
Naylor 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.
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.
Related Links
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Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review
Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients
The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients
The prevalence of symptoms in end-stage renal disease: a systematic review
Research Priorities in CKD: Report of a National Workshop Conducted in Australia
The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature
Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment
Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer
Mortality in Incident Maintenance Dialysis Patients Versus Incident Solid Organ Cancer Patients: A Population-Based Cohort
Renal provider recognition of symptoms in patients on maintenance hemodialysis
Other Identifiers
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2021-A00776-35
Identifier Type: -
Identifier Source: org_study_id
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