| CTRI Number |
CTRI/2024/06/068561 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Financial hardships faced by patients on maintenance hemodialysis and their caregivers. |
|
Scientific Title of Study
|
Financial Hardships in End Stage Kidney Disease Patients on Maintenance Hemodialysis: A prospective cross-sectional study. |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Nikhil Bansal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine and Supportive Care,
Room No. 4,
Shirdi Sai Baba Cancer Research Block,
Kasturba Medical College and Hospital,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9971471275 |
| Fax |
|
| Email |
Bansalnikhil12345@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuja Damani |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine, Room 4, Shirdi Sai Baba Cancer Research Block, Kasturba Medical College and Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9158437827 |
| Fax |
|
| Email |
anuja.damani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Bansal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Palliative Medicine, Room 4, Shirdi Sai Baba Cancer Research Block, Kasturba Medical College and Hospital, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9971471275 |
| Fax |
|
| Email |
bansalnikhil12345@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Karnataka, India
Pin: 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Nikhil Bansal |
| Address |
Department of Palliative Medicine, Room 4, Shirdi Sai Baba Cancer Research Block, Kasturba Medical College and Hospital, Manipal, Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Bansal |
Kasturba Hospital, Manipal |
Dialysis unit, Department of Nephrology
Udupi
KARNATAKA |
9971471275
bansalnikhil12345@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL (It is an observational study) |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with ESKD on maintenance hemodialysis and have been on maintenance hemodialysis for at least 6 months |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Perception of Financial Distress using COST FACIT questionnaire. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |