NCT05837988

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

May 8, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2023

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

April 17, 2023

Last Update Submit

April 27, 2023

Conditions

Keywords

Symptom NetworkHemodialysisSymptom BurdenSymptom Management

Outcome Measures

Primary Outcomes (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.

    at the time of patient enrollment

Study Arms (1)

MHD patients

Cross sectional survey, no intervention measures involved

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Related Publications (23)

  • 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.

  • 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.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Dodd MJ, Miaskowski C, Paul SM. Symptom clusters and their effect on the functional status of patients with cancer. Oncol Nurs Forum. 2001 Apr;28(3):465-70.

  • Weisbord SD, Fried LF, Arnold RM, Rotondi AJ, Fine MJ, Levenson DJ, Switzer GE. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. J Pain Symptom Manage. 2004 Mar;27(3):226-40. doi: 10.1016/j.jpainsymman.2003.07.004.

  • Papachristou N, Barnaghi P, Cooper B, Kober KM, Maguire R, Paul SM, Hammer M, Wright F, Armes J, Furlong EP, McCann L, Conley YP, Patiraki E, Katsaragakis S, Levine JD, Miaskowski C. Network Analysis of the Multidimensional Symptom Experience of Oncology. Sci Rep. 2019 Feb 19;9(1):2258. doi: 10.1038/s41598-018-36973-1.

  • Dicenso A, Bayley L, Haynes RB. Accessing pre-appraised evidence: fine-tuning the 5S model into a 6S model. Evid Based Nurs. 2009 Oct;12(4):99-101. doi: 10.1136/ebn.12.4.99-b. No abstract available.

  • Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. No abstract available.

  • Pearson A, Wiechula R, Court A, Lockwood C. The JBI model of evidence-based healthcare. Int J Evid Based Healthc. 2005 Sep;3(8):207-15. doi: 10.1111/j.1479-6988.2005.00026.x.

  • van Borkulo CD, Borsboom D, Epskamp S, Blanken TF, Boschloo L, Schoevers RA, Waldorp LJ. A new method for constructing networks from binary data. Sci Rep. 2014 Aug 1;4:5918. doi: 10.1038/srep05918.

  • Altenbuchinger M, Weihs A, Quackenbush J, Grabe HJ, Zacharias HU. Gaussian and Mixed Graphical Models as (multi-)omics data analysis tools. Biochim Biophys Acta Gene Regul Mech. 2020 Jun;1863(6):194418. doi: 10.1016/j.bbagrm.2019.194418. Epub 2019 Oct 19.

MeSH Terms

Conditions

SyndromeSigns and Symptoms

Condition Hierarchy (Ancestors)

DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tingting Liu

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

May 1, 2023

Study Start

May 8, 2023

Primary Completion

May 8, 2023

Study Completion

December 31, 2025

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations