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Clinical Trials/CTRI/2024/06/068561
CTRI/2024/06/068561Not yet recruitingNot Applicable

Financial Hardships in End Stage Kidney Disease Patients on Maintenance Hemodialysis: A prospective cross-sectional study.

Dr Nikhil Bansal1 site in 1 country100 target enrollmentStarted: June 17, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Assessment of Perception of Financial Distress using COST FACIT questionnaire.

Study Overview

Brief Summary

More than 2 million people have been diagnosed and treated with life-sustaining dialysis therapy worldwide. Financial hardship is a common challenge among patients with kidney failure on maintenance hemodialysis (mHD) and may have negative overall health consequences. This study aims to evaluate the financial hardships faced by patients with end stage kidney disease (ESKD) on mHD. Patients in the hemodialysis unit on maintenance hemodialysis who fulfills the study inclusion criteria will be explained about study procedure by the study investigator. Patients will be enrolled in the study after obtaining a written informed consent from eligible study participants in the language best understood by them. The COST FACIT questionnaire will be a self administered tool used to assess financial distress of patient/ family caregiver. The patients and/or primary earning member of the family or person who is aware of the financial expenditures related to patients dialysis will be interviewed by the primary investigator for information about the financial aspects of patient care using a structured interview guide to estimate the actual direct and indirect cost of dialysis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients diagnosed with ESKD on maintenance hemodialysis and have been on maintenance hemodialysis for at least 6 months.

Exclusion Criteria

  • Patients who refuse consent for the study participation Unable to read and complete the study questionnaire Patients or carers with lack of information about financial aspect of patient’s dialysis.

Outcomes

Primary Outcomes

Assessment of Perception of Financial Distress using COST FACIT questionnaire.

Time Frame: Baseline

Secondary Outcomes

  • Estimation of Financial Expenditure (Direct & Indirect costs) for treatment of patients with End Stage Kidney Disease (ESKD) on Maintenance Hemodialysis (Average of 3 months) using a structured interview guide.(Baseline)

Investigators

Sponsor
Dr Nikhil Bansal
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr. Nikhil Bansal

Kasturba Medical College Manipal

Study Sites (1)

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