NCT04427800

Brief Summary

Chronic kidney disease (CKD) causes symptoms and potential loss of independence. These effects are increased as the disease progress to endstage renal disease (ESRD), particularly when external intervention (i.e. dialysis) is used to keep these individuals alive. The combined effect of ESRD and its treatment has a significant impact on an individual's life, potentially causing reduced employment time, reduced social time and increased anxiety/stress. The purpose of this study is to investigate the impact that CKD/ESRD have on an individual's life. Specifically, this study is focused on giving an insight into the psychosocial impact that CKD/ESRD and different forms of renal replacement therapy have upon these individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2020

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

June 4, 2020

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thematic analysis of qualitative interview exploring the experiences of renal disease and renal replacement therapy in adults with advanced chronic kidney disease and end-stage renal disease

    Qualitative interviews to explore the above experiences

    Day 1

Study Arms (6)

CKD G4

Chronic kidney disease stage (G4). (eGFR \< 30 mL/min/1.73m2)

CKD G5

Chronic kidney disease stage (G5). (eGFR \< 15 mL/min/1.73m2) with imminent initiation of RRT

ESRD on ICHD

End stage renal disease on in centre haemodialysis

ESRD on HHD

End stage renal disease on home haemodialysis

ESRD on PD

End stage renal disease on peritoneal dialysis

Post-transplant

Participants post-transplant

Eligibility Criteria

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

Adults with advanced CKD/ESRD (eGFR \< 30 mL/min/1.73m2 ) will be recruited into this study. Persons falling into six distinct categories will be approached: 1. CKD G4 2. CKD G5 with imminent initiation of RRT 3. ESRD on ICHD 4. ESRD on HHD 5. ESRD on PD 6. Post-transplant

You may qualify if:

  • Aged 18 years or older Willing and able to undertake the interview process Able to give informed consent

You may not qualify if:

  • Age \< 18 years Does not provide written informed consent Any neurological/psychiatric diagnoses Lack of fluency in English Individuals who have commenced RRT within three months of the study start date Transplant patients being seen in clinic more than once every fortnight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport Health and Exercise Science

Portsmouth, Outside the United States Or Canada, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Physical Activity, Exercise and Health

Study Record Dates

First Submitted

June 4, 2020

First Posted

June 11, 2020

Study Start

October 4, 2019

Primary Completion

November 24, 2020

Study Completion

November 24, 2020

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Transcripts will not be uploaded to a repository

Locations