| CTRI Number |
CTRI/2021/12/039031 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life and weakness of old age chronic hemodialysis patients
during COVID-19 situation |
|
Scientific Title of Study
|
Quality of Life and Frailty among elderly on Maintenance Hemodialysis
during COVID-19 pandemic: A Cross-sectional Study |
| Trial Acronym |
QoL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna M |
| Designation |
PG Student |
| Affiliation |
Manipal College of Health Professions, Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professions,
Manipal Academy of Higher Education
Manipal
Rajaji hostel
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7025521972 |
| Fax |
|
| Email |
krishna.m@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharshan Rangaswamy |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Hospital and Medical College |
| Address |
Department of Nephrology, Kasturba Medical College, Manipal, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901970787 |
| Fax |
|
| Email |
dharshan.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharshan Rangaswamy |
| Designation |
Additional Professor |
| Affiliation |
Kasturba Hospital and Medical College |
| Address |
Department of Nephrology, Kasturba Medical College, Manipal, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9901970787 |
| Fax |
|
| Email |
dharshan.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital and Medical College |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Kasturba Hospital and Medical College
Manipal, Udupi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shankar Prasad |
Kasturba Hospital and Medical College |
Dialysis Unit
Kasturba hospital and Medical College
Manipal
Udupi
KARNATAKA |
08202922487
shankar.prasad@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institustional Ethics Commitee |
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
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients of age ≥60 years on maintenance hemodialysis for ≥ 3 months |
|
| ExclusionCriteria |
| Details |
Poor mental & physical health (KARNOFSKY PERFORMANCE STATUS SCALE <50%)
Admitted patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HR-Qol score (0 – 100) in study population |
1 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Frailty index score (0 – 10) in study population.
Correlation between HR-QoL and prevalence of frailty among elderly hemodialysis population.
|
1 week |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
25/01/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study helps to determine the health-related quality of life among elderly on chronic maintenance hemodialysis and the prevalence of frailty among them during COVID-19 pandemic situation. Approximately 75 participants participate in this study. Screening of the participants are done by Karnofsky Performance Status Scale. An explanation of the study will be given, as well as informed consent will be take. The required data of the participant’s demographic profile and investigation reports and dialysis reports are taken from patient’s hospital records with the help of proforma. Few questionnaires will be administered to assess health related quality of life and frailty of the maintenance hemodialysis patients. These include Kidney Disease Quality of Life Short Form-36 (KDQoL SF-36) and Frailty Index For Elderly FIFE). The SF-36 score and FIFE score will be calculated. Currently, no study has explored the prevalence of frailty and the impact of quality of life on frailty among elderly maintenance hemodialysis patients in India. The impact of COVID-19 pandemic has altered the daily routine among the elderly hemodialysis patients. The COVID restrictions such as, social distancing, self-quarantine, etc has led to physical and psychological difficulties in them. The study would help to determine the psycho-social impact and changes in physical capacity among ESKD patients during COVID related restrictions. |