| CTRI Number |
CTRI/2024/11/076545 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study- longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Study on ability to understand feelings, Symptoms and Quality of life in Hemodialysis patients. |
|
Scientific Title of Study
|
Correlation of psychological flexibility with Symptom Burden and quality of life
in hemodialysis patients: A single center study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC1:319/2024 dated 27/08/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shankar Prasad N |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal Academy of higher Education, Manipal |
| Address |
Room No.15, OPD Block, Department of Nephrology, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankar.prasad@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar Prasad N |
| Designation |
Professor and Unit Head |
| Affiliation |
Kasturba Medical College, Manipal Academy of higher Education, Manipal |
| Address |
Room No.15, OPD Block, Department of Nephrology, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739905443 |
| Fax |
|
| Email |
shankar.prasad@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan V Bhojaraja |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal Academy of higher Education, Manipal |
| Address |
Room No.15, OPD Block, Department of Nephrology, KMC, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE, Manipal. Pin code: 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College, Manipal. |
| Address |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 N |
Kasturba Hospital, Manipal. Karnataka |
Room.No. 15, Department of Nephrology, KMC, Manipal. Karnataka
Udupi
KARNATAKA |
9739905443
shankar.prasad@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years undergoing maintenance hemodialysis for minimum 3 months. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to consent, Acute Kidney Injury, Pre-existing psychological disorders, Peritoneal Dialysis patients, Kidney transplant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation between psychological flexibility and severity of symptom burden and quality of life
in hemodialysis patients. |
3 Months |
|
|
Secondary Outcome
|
|
|
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)
|
15/11/2024 |
| 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="0"
Months="3"
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
|
This is a Single center Prospective longitudinal study, purpose of the study is correlation between psychological flexibility with anxiety-depression, Quality
of life and symptom burden in hemodialysis patients. using questionnaires like Psy-Flex, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, WHOQOL-BREF and ESAS-R. A trained Interviewer will complete the questionnaire when patients undergoing Hemodialysis. the primary outcome measure correlation between psychological flexibility and severity of symptom burden and quality of life
in hemodialysis patients.
After the assessment, patient will be seen by the consent physician/Nephrologist/Palliative
physician/psychologist and reevaluated same patient next 4 weeks. |