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

Patients Reported Outcomes Clinical Trial

— FSWIFT-PILOT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05154708
• Other study ID #: 2021-A00776-35
• Status: Recruiting
• Start date: January 27, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: May 2023
• Source: Central Hospital, Nancy, France
• Contact: Amandine ZIEGLER
• Phone: 03 83 85 28 52
• Email: a.ziegler[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 22, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

• 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

Related Conditions & MeSH terms

• Patients Reported Outcomes

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre-les-Nancy

Sponsors (4)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Agence de La Biomédecine, Association France REIN, CIC 1433 EC CHRU de Nancy

Country where clinical trial is conducted

France, 

References & Publications (12)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Aga — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Resea — View Citation

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 an — View Citation

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( — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 months
Secondary	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	6 months

External Links

•   Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey
•   Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
•   Impact of pain and symptom burden on the health-related quality of life of hemodialysis patients
•   Mortality in Incident Maintenance Dialysis Patients Versus Incident Solid Organ Cancer Patients: A Population-Based Cohort
•   Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment
•   Renal provider recognition of symptoms in patients on maintenance hemodialysis
•   Research Priorities in CKD: Report of a National Workshop Conducted in Australia
•   Scope and Consistency of Outcomes Reported in Randomized Trials Conducted in Adults Receiving Hemodialysis: A Systematic Review
•   The impact of chronic pain on depression, sleep, and the desire to withdraw from dialysis in hemodialysis patients
•   The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature
•   The prevalence of symptoms in end-stage renal disease: a systematic review
•   Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer