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Symptom ClusterNCT05837988

Construction of Symptom Network in Maintenance Hemodialysis Patients

An observational study of Symptom Cluster and Symptoms and Signs, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Through a cross-sectional questionnaire survey, a general information questionnaire and Dialysis Frequency, Severity, and Symptom Burden Index were used to investigate the frequency, severity, and degree of symptom distress in MHD patients, and to analyze the differences in symptom distress status between long and… Read more about this study

Who is it for?
Ages 18 years and older
How many people
517 participants
Where
1 siteChina
Study dates
8 May 2023to 31 Dec 2025
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
  • No healthy volunteers
  • Adult, Older adult

Study population: The participants are maintenance hemodialysis patients selected by convenience sampling method from six blood purification centers, including the East, West, South, Baoshan Branch of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Ningbo Hangzhou Bay Hospital, and Punan Hospital.

Who may be able to join

  • Age not less than 18 years old;
  • Regular hemodialysis time greater than or equal to 3 months;
  • The dialysis plan did not change within one month;
  • Informed consent and voluntary participation in this study.

Who cannot join

  • Previous or current mental illness;
  • Cognitive impairment;
  • Acute cardiovascular and cerebrovascular disease;
  • Acute infection period;
  • Complications such as severe cerebrovascular sequelae and tumors.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Tingting Liu, +8615001969018, lettyliu7@163.com

Other trials in China

About this study

Through a cross-sectional questionnaire survey, a general information questionnaire and Dialysis Frequency, Severity, and Symptom Burden Index were used to investigate the frequency, severity, and degree of symptom distress in MHD patients, and to analyze the differences in symptom distress status between long and short dialysis age MHD patients. Using the R 4.2.2 software qgraph package, construct symptom networks for MHD patients of long and short dialysis age through network analysis. Analyze network centrality indicators, including intensity, closeness centrality, and mediation centrality, to identify core symptoms and compare if there are any differences between the two groups, aiming to lay the foundation for precise and efficient phased symptom management.

Read the detailed description

End stage renal disease (ESRD) is caused by various kidney diseases, leading to irreversible decline in renal function. The main renal replacement therapy (RRT) for ESRD is hemodialysis (HD), peritoneal dialysis (PD), and kidney transplantation. Due to the impact of kidney supply on kidney transplantation, it is limited in clinical practice, and hemodialysis has become the most common method of RRT in most countries. According to the registration system of the Chinese Research Data Services (CNRDS), as of the end of 2021, there were 751098 dialysis patients and 155738 new patients in China, with an average dialysis age of 50.9 months. The proportion of patients with dialysis age greater than 5 years was 31.5%. There are a large number of hemodialysis patients with a longer dialysis age.

With the continuous development of dialysis technology, the survival rate of maintenance hemodialysis (MHD) patients is becoming higher and higher. However, MHD patients may experience various symptoms during long-term treatment, which is the main cause of discomfort and physical and mental health for patients. The physical and mental pain or torment experienced by patients due to the disease itself and/or the symptoms caused by treatment is called symptom distress. Multiple studies have shown that the incidence of symptom distress in MHD patients ranges from 13.75% to 91.5%, which is at a high level. Symptom distress is negatively correlated with the quality of life of MHD patients. Excessive symptom distress increases the cost of treatment and exacerbates the psychological burden on patients. Persistent symptom burden can significantly affect the quality of life of MHD patients and increase their mortality rate. MHD patients suffer from multiple symptoms at the same time. Li Jiuhong et al.'s research results show that MHD patients experience a total of 3-25 (13.12 ± 5.27) symptoms, which is similar to Weisbord et al.'s average of 9 symptoms. MHD patients experience a wide variety of symptoms, and how to accurately and effectively manage symptoms is the future research direction.

With the prolongation of dialysis treatment time for patients, some urea toxin that cannot be completely cleared by dialysis accumulates in the patient's body, which is closely related to discomfort symptoms such as itching, joint pain, and difficulty falling asleep. Ran Yuli et al. found that the dialysis age of MHD patients is negatively correlated with their physical function and role. With the prolongation of dialysis age, the physiological function of MHD patients will decrease to varying degrees, and various disease-related complications will also occur. The focus of symptom management will shift accordingly. Conducting grouping studies based on dialysis age for MHD patients has certain clinical significance. At present, domestic scholars use a 5-year hemodialysis period as the boundary, dividing dialysis age>5 years into long dialysis age, and dialysis age ≤ 5 years into short dialysis age. Hu Qian and others set up symptom management consultants to develop symptom management pathways and guide responsible nurses to implement symptom management for patients according to the pathway table. The results indicate that setting up symptom management consultants can reduce the incidence of symptoms in MHD patients, improve their quality of life, and improve patient satisfaction. A meta-analysis showed that aerobic exercise can improve several symptoms related to hemodialysis in adults receiving MHD, including restless leg syndrome, depressive symptoms, muscle spasms, and fatigue. Zhao Ying et al. used air wave pressure therapy to prevent dialysis related muscle spasms, Zuo et al. managed symptoms of fatigue through nurse led non drug multidisciplinary holistic care, Beerappa et al. improved sleep disorders in MHD patients through aromatherapy, Guo Junjun et al. improved fatigue symptoms and alleviated sleep disorders in MHD patients through acupoint massage. When conducting symptom management for MHD patients, existing studies have not distinguished the age of dialysis, and currently, symptom management for MHD patients mainly focuses on a single symptom or symptom group, ignoring the interaction between multiple symptoms in the real world. In real clinical situations, patients often have multiple symptoms at the same time, and it is urgent to identify the core symptoms of patients to improve the accuracy and efficiency of symptom management.

With the development of information technology, big data analysis technology, and the innovation of complex scientific research concepts in the real world, the concept of symptom networks is gradually replacing the previous research paradigm that focuses on individual symptoms and must control other variables. Symptom network is a collective representation of symptoms related to a patient's disease, and based on complex network analysis to quantitatively study the correlation between different symptoms. It studies the network structure, nodes, and network indicators composed of individual symptoms to reflect the interaction mechanism of symptoms in the real world and provide precise intervention targets. Discovering core symptom targets through symptom networks can improve the management efficiency and intervention accuracy of symptom management, evolving from the working mode of "having multiple symptoms and providing multiple sets of intervention measures" to "identifying intervention targets and providing intervention measures targeting target symptoms". Since Fried et al. first proposed the concept of symptom networks in 2015, the research paradigm of symptom networks has been applied in psychopathology, chronic disease symptom management, long-term follow-up of tumors, and patient self-management. Lin et al. constructed a self-reported psychological and neurological symptom network for head and neck cancer patients through network analysis. The results showed that network analysis clarified the interrelationships between five psychological and neurological symptoms, and identified depression as the core symptom. It is recommended to develop symptom management measures for depression in clinical practice. Han et al. constructed symptom networks for autism and schizophrenia. Yang Hongli et al. applied symptom networks to HIV infected individuals and identified fatigue as the core symptom. They suggested that when HIV infected individuals have multiple symptoms at the same time, high-intensity and precise intervention on fatigue can reduce the transmission of fatigue as a mediating bridge in the symptom network, reduce the severity of fatigue symptoms, and also alleviate the severity of other symptoms. As mentioned above, symptom network analysis can identify core symptoms, and changing these core symptoms may be an important entry point for changing the entire network. In practical clinical work, implementing key interventions by nurses on core symptoms can more effectively improve other related symptoms and improve intervention efficiency. Applying symptom networks to the field of symptom management is a promising and precise technology in real-world clinical settings.

This study has developed a symptom distress questionnaire for maintenance hemodialysis patients. Previous literature on symptom distress and symptom management in MHD patients has been reviewed. Whether there are differences in symptom distress among MHD patients of different dialysis ages, and how to identify the core symptoms of MHD patients of different dialysis ages through symptom networks to improve the accuracy and effectiveness of intervention are all directions that need to be studied in the future. The research hypotheses of this study are: ① There are differences in the frequency, severity, and degree of symptom distress between long and short dialysis age MHD patients; ② By using network analysis methods to construct symptom networks for long and short dialysis age MHD patients, identify the core symptoms of different dialysis age MHD patients. Based on literature review and clinical experience, it is assumed that the core symptoms of long dialysis age MHD patients are itching or dry skin, while the core symptoms of short dialysis age MHD patients are fatigue or dry mouth.

Keywords
Symptom Network, Hemodialysis, Symptom Burden, Symptom Management
Medical subject headings
Syndrome, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05837988
Study groupRoleWhat they receive
MHD patientsCross sectional survey, no intervention measures involved

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symptom burden

    Through a cross-sectional questionnaire survey, the Dialysis Frequency, Severity, and Symptom Burden Index were used to investigate the frequency, severity, and degree of symptom distress in MHD patients, and to analyze the differences in symptom distress status between long and short dialysis age MHD patients.

    Measured: at the time of patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start8 May 2023 (estimated)
  3. Primary completion8 May 2023 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
517 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05837988
Sponsor's protocol ID
LY2023-071-B
Status last verified
Apr 2023
First submitted
17 Apr 2023
Last updated
1 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.

    PubMed 27887750
  • Pippias M, Stel VS, Abad Diez JM, Afentakis N, Herrero-Calvo JA, Arias M, Tomilina N, Bouzas Caamano E, Buturovic-Ponikvar J, Cala S, Caskey FJ, Castro de la Nuez P, Cernevskis H, Collart F, Alonso de la Torre R, Garcia Bazaga Mde L, De Meester J, Diaz JM, Djukanovic L, Ferrer Alamar M, Finne P, Garneata L, Golan E, Gonzalez Fernandez R, Gutierrez Avila G, Heaf J, Hoitsma A, Kantaria N, Kolesnyk M, Kramar R, Kramer A, Lassalle M, Leivestad T, Lopot F, Macario F, Magaz A, Martin-Escobar E, Metcalfe W, Noordzij M, Palsson R, Pechter U, Prutz KG, Ratkovic M, Resic H, Rutkowski B, Santiuste de Pablos C, Spustova V, Suleymanlar G, Van Stralen K, Thereska N, Wanner C, Jager KJ. Renal replacement therapy in Europe: a summary of the 2012 ERA-EDTA Registry Annual Report. Clin Kidney J. 2015 Jun;8(3):248-61. doi: 10.1093/ckj/sfv014. Epub 2015 Mar 23.

    PubMed 26034584
  • Thurlow JS, Joshi M, Yan G, Norris KC, Agodoa LY, Yuan CM, Nee R. Global Epidemiology of End-Stage Kidney Disease and Disparities in Kidney Replacement Therapy. Am J Nephrol. 2021;52(2):98-107. doi: 10.1159/000514550. Epub 2021 Mar 22.

    PubMed 33752206
  • McCorkle R, Young K. Development of a symptom distress scale. Cancer Nurs. 1978 Oct;1(5):373-8. No abstract available.

    PubMed 250445
  • You AS, Kalantar SS, Norris KC, Peralta RA, Narasaki Y, Fischman R, Fischman M, Semerjian A, Nakata T, Azadbadi Z, Nguyen DV, Kalantar-Zadeh K, Rhee CM. Dialysis symptom index burden and symptom clusters in a prospective cohort of dialysis patients. J Nephrol. 2022 Jun;35(5):1427-1436. doi: 10.1007/s40620-022-01313-0. Epub 2022 Apr 16.

    PubMed 35429297
  • Wang X, Shi Q, Mo Y, Liu J, Yuan Y. Palliative care needs and symptom burden in younger and older patients with end-stage renal disease undergoing maintenance hemodialysis: A cross-sectional study. Int J Nurs Sci. 2022 Oct 4;9(4):422-429. doi: 10.1016/j.ijnss.2022.09.015. eCollection 2022 Oct.

    PubMed 36285085
  • Weisbord SD, Fried LF, Arnold RM, Fine MJ, Levenson DJ, Peterson RA, Switzer GE. Prevalence, severity, and importance of physical and emotional symptoms in chronic hemodialysis patients. J Am Soc Nephrol. 2005 Aug;16(8):2487-94. doi: 10.1681/ASN.2005020157. Epub 2005 Jun 23.

    PubMed 15975996
  • Hargrove N, El Tobgy N, Zhou O, Pinder M, Plant B, Askin N, Bieber L, Collister D, Whitlock R, Tangri N, Bohm C. Effect of Aerobic Exercise on Dialysis-Related Symptoms in Individuals Undergoing Maintenance Hemodialysis: A Systematic Review and Meta-Analysis of Clinical Trials. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):560-574. doi: 10.2215/CJN.15080920. Epub 2021 Mar 25.

    PubMed 33766925
  • Zuo M, Zhu W, Lin J, Zhuo J, He X, Jing X, Tang J, Deng R. The impact of nurse-led nonpharmacological multidisciplinary holistic nursing care on fatigue patients receiving hemodialysis: a randomized, parallel-group, controlled trial. BMC Nurs. 2022 Dec 12;21(1):352. doi: 10.1186/s12912-022-01126-3.

    PubMed 36503477
  • Beerappa H, Gt K, Chandrababu R. The Effects of Inhalational Lavender Essential Oil Aromatherapy on Sleep Quality in Hemodialysis Patients: A Before-and-After-Intervention Trial. Holist Nurs Pract. 2023 Nov-Dec 01;37(6):356-362. doi: 10.1097/HNP.0000000000000521. Epub 2022 Jun 1.

    PubMed 35703289
  • Fried EI, Boschloo L, van Borkulo CD, Schoevers RA, Romeijn JW, Wichers M, de Jonge P, Nesse RM, Tuerlinckx F, Borsboom D. Commentary: "Consistent Superiority of Selective Serotonin Reuptake Inhibitors Over Placebo in Reducing Depressed Mood in Patients with Major Depression". Front Psychiatry. 2015 Aug 21;6:117. doi: 10.3389/fpsyt.2015.00117. eCollection 2015. No abstract available.

    PubMed 26347663
  • Kachadourian LK, Harpaz-Rotem I, Tsai J, Southwick SM, Pietrzak RH. Posttraumatic Stress Disorder Symptoms, Functioning, and Suicidal Ideation in US Military Veterans: A Symptomics Approach. Prim Care Companion CNS Disord. 2019 Apr 25;21(2):18m02402. doi: 10.4088/PCC.18m02402.

    PubMed 31050228
  • Lin Y, Bruner DW, Paul S, Miller AH, Saba NF, Higgins KA, Shin DM, Zhang W, Miaskowski C, Xiao C. A network analysis of self-reported psychoneurological symptoms in patients with head and neck cancer undergoing intensity-modulated radiotherapy. Cancer. 2022 Oct;128(20):3734-3743. doi: 10.1002/cncr.34424. Epub 2022 Aug 15.

    PubMed 35969226
  • Han GT, Trevisan DA, Foss-Feig J, Srihari V, McPartland JC. Distinct Symptom Network Structure and Shared Central Social Communication Symptomatology in Autism and Schizophrenia: A Bayesian Network Analysis. J Autism Dev Disord. 2023 Sep;53(9):3636-3647. doi: 10.1007/s10803-022-05620-0. Epub 2022 Jun 25.

    PubMed 35752729
  • Danquah FV, Zimmerman L, Diamond PM, Meininger J, Bergstrom N. Frequency, severity, and distress of dialysis-related symptoms reported by patients on hemodialysis. Nephrol Nurs J. 2010 Nov-Dec;37(6):627-38; quiz 639.

    PubMed 21290917

Questions about this trial

What is this clinical trial studying?

An observational study of Symptom Cluster and Symptoms and Signs, run by RenJi Hospital at 1 site in China.

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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 May 2023. 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yunyue Guo (00862168383312, guoyunyue@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

symptom burden (time frame: at the time of patient enrollment). 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 NCT05837988, which also lists 23 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 1 May 2023.

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