| CTRI Number |
CTRI/2026/01/100605 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of the quality of life of patients receiving hemodialysis |
|
Scientific Title of Study
|
Exploring the Components of Quality of Life of the Patients Undergoing Hemodialysis at a Tertiary Hospital in Southern India: A Qualitative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shifaz Begum |
| Designation |
Student researcher |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology,
Manipal College of Health Professions (MCHP),
Manipal Academy of Higher Education (MAHE),
Manipal - 576104
Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8123768422 |
| Fax |
|
| Email |
shifaz.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs. Bharathi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology
Manipal College of Health Professions, MCHP
Manipal Academy of Higher Education, MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008168494 |
| Fax |
|
| Email |
bharathi.parkala@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs. Bharathi |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology,
Manipal College of Health Professions, MCHP
Manipal Academy of Higher Education, MAHE
Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9008168494 |
| Fax |
|
| Email |
bharathi.parkala@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Not applicable ] |
|
|
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 |
| Shifaz Begum |
Kasturba Medical College (KMC) |
CSOT block, 3rd floor Dialysis unit, Manipal, Karnataka - 576104, India
Udupi
KARNATAKA |
8123768422
shifazbegum9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Manipal |
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 |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above undergoing maintenance hemodialysis at a tertiary care hospital in Southern India and willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients with cognitive impairment, diagnosed psychiatric illness, severe acute illness at the time of interview, or those unwilling to provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of key components influencing quality of life in patients undergoing hemodialysis |
At the time of the interview |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding the emotional, physical, social, and financial impact on participants and their perceptions of supportive care |
At the time of the interview |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
18/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing hemodialysis face numerous challenges that impact their quality of life. These challenges include physical symptoms, emotional distress, social limitations, and financial burden. This qualitative study aims to explore the various components of quality of life among patients undergoing hemodialysis at a tertiary care hospital in Southern India. This study will use in-depth interviews to understand patient experiences, perceptions of illness, coping mechanisms, and supportive care needs. The findings of this study are expected to provide insights that may help improve patient-centered care and supportive services for individuals on long-term hemodialysis. |