| CTRI Number |
CTRI/2024/05/067857 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Above study will provide the relationship among nutritional status and psychological variables in Hemodialysis patients |
|
Scientific Title of Study
|
A Study to Assess the Nutritional Status and its Association with Clinical, Psychological Variables and Quality of life among Chronic kidney disease patients, undergoing Haemodialysis in AIIMS New Delhi. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yamini Joshi |
| Designation |
M.Sc Nursing student |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
PORTA CABIN 2
College of Nursing
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI
South West
DELHI
110029
India |
| Phone |
9953248647 |
| Fax |
|
| Email |
yaminijoshi.5771@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajesh kumar TK |
| Designation |
Associate professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
2nd Floor
Room no 1
Next to Porta Cabin 1
College of Nursing
ALL INDIA INSTITUTE MEDICAL SCIENCE New Delhi
South West
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajesh Kumar TK |
| Designation |
Associate Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
2nd Floor Room no 1
Next to Porta Cabin 1
College of Nursing
ALL INDIA INSTITUTE OF MEDICAL SCIENCES New Delhi 110029
South West
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkumari Amrit Kaur Nephrology OPD 4th floor
Department of Nephrology
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
College of Nursing
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI 110029
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Mahajan |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
New Rajkumari Amrit Kaur OPD
Department of nephrology
4th floor All INDIA INSTITUTE OF MEDICAL SCIENCES
NEW DELHI
South West
DELHI |
9810546844
Mahajansn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patient ≥ 18 years
2.Patient who read ,understand and write english and hindi
3.Chronic kidney disease patients undergoing Haemodialysis from last 3 months at least 2 times per week
|
|
| ExclusionCriteria |
| Details |
• Patients not willing to participate
• Chronic kidney disease patients undergoing Haemodialysis diagnosed with known GastroIntestinal comorbidities.
• Chronic kidney disease patients categorized under stage 1-4 according to KDOQI Guidelines
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nutritional parameters and psychological parameter with MIS score and DASS21 respectively |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Qualty of life among chronic kidney disease patients undergoing haemodialysis |
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)
|
01/08/2024 |
| 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="4"
Days="2" |
|
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
|
Nutritional status of CKD patients undergoing Haemodialysis will be assessed by MIS SCORE and psychological variables including depression and anxiety will be assessed by DASS 21 TOOL and its association will be noted down |