NCT04225416

Brief Summary

This study is exploring symptom burden, health experiences and expectations of treatment and survival of seriously ill dialysis patients and their physicians.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 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

Study Start

First participant enrolled

November 16, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6 years

First QC Date

January 6, 2020

Last Update Submit

October 19, 2022

Conditions

Keywords

hemodialysisperitoneal dialysis

Outcome Measures

Primary Outcomes (1)

  • Current practice regarding discussion of prognosis with seriously ill dialysis patients, to better understand the dissonance between physician and patient beliefs on prognosis, transplant candidacy and goals of care.

    Completion of questionnaire or structured interview

    Through study completion, an average of 2 years

Secondary Outcomes (3)

  • Number of dialysis patients who are more optimistic about prognosis and transplant candidacy than their nephrologists

    Through study completion, an average of 2 years

  • Patients' prognostic expectations are associated with their treatment preferences

    Through study completion, an average of 2 years

  • Number of patients with dialysis associated symptoms as assessed by IPOS Renal (https://pos-pal.org/maix/ipos-renal-in-english.php).

    7 days

Study Arms (2)

Hemodialysis patients

Patients undergoing hemodialysis

Other: Questionnaire/Structured Interview

Peritoneal dialysis patients

Patients undergoing peritoneal dialysis

Other: Questionnaire/Structured Interview

Interventions

No intervention

Hemodialysis patientsPeritoneal dialysis patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dialysis patients

You may qualify if:

  • Haemodialysis patients 18-100 years old, with a predicted mortality risk of \>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.
  • Peritoneal dialysis patients 18-100 years old, with a predicted mortality risk of \>20% in the next year, their close person and staff members (nurse and doctor) caring for the patient.

You may not qualify if:

  • Patients on home haemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Edwina Brown, MBChB

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Beckwith, MBChB

CONTACT

Study Design

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

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 13, 2020

Study Start

November 16, 2018

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations