| CTRI Number |
CTRI/2022/05/042879 [Registered on: 27/05/2022] Trial Registered Prospectively |
| Last Modified On: |
26/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on knowledge about nutrition, Quality of life and nutrition education intervention amongst caregivers of Chronic Kidney Disease(CKD) and dialysis patients. |
|
Scientific Title of Study
|
A study on nutritional knowledge, Quality of life and
nutrition education intervention among caregivers of Chronic Kidney Disease (CKD) and dialysis patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purvi Gupta |
| Designation |
PG student |
| Affiliation |
SVT COLLEGE OF HOME SCIENCE |
| Address |
A/9 704 Swayam Poonam garden Mira road
Mumbai
MAHARASHTRA
401107
India |
| Phone |
|
| Fax |
|
| Email |
purvig08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Diti Shah |
| Designation |
PG student |
| Affiliation |
SVT COLLEGE OF HOME SCIENCE |
| Address |
96/501, Road no.5, Sanmati sadan, Jawahar Nagar, Goregoan West
Mumbai
MAHARASHTRA
4000104
India |
| Phone |
|
| Fax |
|
| Email |
ditishah99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuradha Ramesh |
| Designation |
Ph.D, Assistant Professor |
| Affiliation |
SVT COLLEGE OF HOME SCIENCE |
| Address |
SNDT Womens University, SVT college of home science,
Juhu Road,
Santacruz (West)
Mumbai
MAHARASHTRA
400049
India |
| Phone |
|
| Fax |
|
| Email |
anuradha.ramesh@svt.edu.in |
|
|
Source of Monetary or Material Support
|
| SVT College Of Home Science |
|
|
Primary Sponsor
|
| Name |
SVT College Of Home Science |
| Address |
SNDT Womens University, SVT College of home science,
Juhu Road,
Santacruz (West) |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Anuradha Ramesh |
SVT COLLEGE OF HOME SCIENCE |
SNDT Womens University, SVT college of home science, Juhu
Road, Santacruz (West)
Mumbai
MAHARASHTRA
400049
Mumbai
MAHARASHTRA |
8291919759
anuradha.ramesh@svt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SEVA MANDAL EDUACTION SOCIETYS INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
caregivers of CKD and Dialysis patients
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
CKD and Dialysis caregivers |
|
| ExclusionCriteria |
| Details |
Transplant patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
â— To study the knowledge related to nutrition among caregivers of CKD patients.
â— To measure the Quality of Life among caregivers of CKD patients.
â— To design nutritional intervention among caregivers of CKD and dialysis patients.
â— To conduct the intervention among caregivers of CKD and dialysis patients.
|
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To conduct the intervention among caregivers of CKD and dialysis patients.
â— To assess the effect of intervention among caregivers of CKD and dialysis patients after 1
month. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/05/2022 |
| 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="1"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The population with chronic kidney disease (CKD) is increasing rampantly due to the increasing
risk factors of hypertension, diabetes, and obesity. A growing number of patients with chronic
kidney disease are receiving home-based care and entail support from healthcare providers, often
family members, to manage the people with CKD. Caregivers are identified as the individuals who
throughout treatment are most closely involved in caring for the patient and assisting the patient
to accommodate and manage their chronic illness. It has been stated in the literature that caregiving
demands in managing CKD that has a profound and persistent effect on family and friends can
exact a toll on the physical, social and emotional wellbeing of caregivers. Yet, caregivers’ needs
are out of sight and overlooked in the medical management of CKD. These situations may
consequently impact negatively on the overall outcome of the CKD patients. Informal caregivers
also experience stress from the additional responsibilities of managing the patients’ medical
treatments, dietary needs, various clinic appointments and other psychosocial issues. The results
of varied studies indicate that caregivers of CKD patients are stressed physically, emotionally and
financially and are subsequently exposed to a diversity of physical and psychological risks. Also,
existing research indicates that there are dietary and nutritional interventions that caregivers can
be educated to use in hopes of alleviating some of the challenging symptoms that occur with CKD.
Support interventions are likely to improve caregivers’ quality of life, satisfaction quotient and
ability to manage better, which can indirectly improve medical and psychosocial outcomes for the
care recipient. Caregivers are those who are most involved in patient care and support during the
disease to help the patient adapt and manage the sickness. Caregivers for hemodialysis patients
play a critical role in their lives. Caregivers for hemodialysis patients play a critical role in their
lives. They are responsible for their care, medical treatment, and nourishment, as well as
accompanying patients to dialysis units, assisting them in daily tasks, and providing psychological
support. Families of individuals with chronic renal failure should provide assistance and care at home or in outpatient settings like hospital dialysis facilities. Patients with chronic kidneydisease
(CKD) are increasingly getting home-based treatment and relying on non-professional healthcare
providers, frequently family members, to help them manage their condition. Caregiving
obligations, particularly in managing CKD, which has a significant and widespread influence on
family and friends, are thought to take a toll on carers’ physical, social, and emotional well-being.
The extra obligations of monitoring the patients’ medical treatments, food requirements, clinic
appointments, and emotional concerns cause stress for informal carers. The high prevalence of
physical and mental disorders among carers reflects the effects of persistent stress on them. The
chronic nature of renal failure, different comorbidities of CKD, and major changes in patients’
lifestyles all contribute to the development of the disease. The role and challenges faced by
caregivers in the various domains needs to be studied for effective patient management of CKD
and Dialysis patients |