Impact of the Routine Collection of Symptoms on Quality of Life in Dialysis Patients

NCT05154708 | Terminated

• 1 other identifier: 2021-A00776-35
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Patients Reported Outcomes

Keywords

symptoms; Patients reported outcomes; dialysis patients

Outcome Measures

Primary Outcomes (1)

• 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.

  11 months

Secondary Outcomes (2)

• Results of the focus groups with patients and health professionals

  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

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Agence de La Biomédecine: collaborator
• Association France REIN: collaborator

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (12)

• 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.

  PMID: 17034633 BACKGROUND

• 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.

  PMID: 28238554 BACKGROUND

• 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.

  PMID: 29475768 BACKGROUND

• 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.

  PMID: 20303025 BACKGROUND

• 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.

  PMID: 16310620 BACKGROUND

• 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.

  PMID: 17200048 BACKGROUND

• 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.

  PMID: 25943716 BACKGROUND

• 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.

  PMID: 18175207 BACKGROUND

• 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.

  PMID: 28586821 BACKGROUND

• 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.

  PMID: 30667494 BACKGROUND

• 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.

  PMID: 30738630 BACKGROUND

• 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.

  PMID: 17702730 BACKGROUND

Related Links

• 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

Study Officials

• Luc FRIMAT

  CHRU de Nancy

  PRINCIPAL INVESTIGATOR

• Olivier Moranne

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

• Nelly CASTIN

  ALTIR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 13, 2021
• Study Start: January 27, 2022
• Primary Completion: November 13, 2023
• Study Completion: February 22, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)