| CTRI Number |
CTRI/2022/04/041933 [Registered on: 19/04/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [EMPOWERMENT PROGRAM] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to gain indepth understanding of Quality of Life of patients undergoing Hemodialysis and assess the effect of Family Empowerment program (Hemodialysis guide and Counseling) on Quality of Life, Adherence, Clinical Outcome and Care giver Burden |
|
Scientific Title of Study
|
Lived experience of patients undergoing hemodialysis and the effect of Empowerment Program on Patients and Caregivers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parameswari M |
| Designation |
Professor |
| Affiliation |
Faculty of Nursing Dr MGR Educational and Research Institute |
| Address |
Faculty of Nursing
Dr MGR Educational and Research Institute
Velappanchavadi
Chennai
Tamilnadu
INDIA
Velappanchavadi
Chennai
Tamilnadu
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8973212022 |
| Fax |
|
| Email |
parameswari.nurse@drmgrdu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema VH |
| Designation |
Principal |
| Affiliation |
Faculty of Nursing Dr MGR Educational and Research Institute |
| Address |
Faculty of Nursing
Dr MGR Educational and Research Institute
Velappanchavadi
Chennai
Tamilnadu
INDIA
Velappanchavadi
Chennai
Tamilnadu
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8973212022 |
| Fax |
|
| Email |
principal-nursing@drmgrdu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Parameswari M |
| Designation |
Professor |
| Affiliation |
Faculty of Nursing Dr MGR Educational and Research Institute |
| Address |
Faculty of Nursing
Dr MGR Educational and Research Institute
Velppanchavadi
Chennai
Tamilnadu
India
Velppanchavadi
Chennai
Tamilnadu
India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
8973212022 |
| Fax |
|
| Email |
parameswari.nurse@drmgrdu.ac.in |
|
|
Source of Monetary or Material Support
|
| A.C.S Medical College and Hospital, Velappanchavadi, Chennai - Infrastructure Support |
|
|
Primary Sponsor
|
| Name |
PARAMESWARI M |
| Address |
FACULTY OF NURSING
DR MGR EDUCATIONAL AND RESEARCH INSTITUTE
VELAPPANCHAVADI
CHENNAI
TAMILNADU
INDIA |
| Type of Sponsor |
Other [(Self)] |
|
|
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 |
| Parameswari M |
ACS Medical College and Hospital |
Velappanchavadi
Chennai
Tamilnadu
India
Thiruvallur
TAMIL NADU |
8973212022
parameswari.nurse@drmgrdu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ACS MEDICAL COLLEGE AND HOSPITAL |
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 |
Empowerment program |
Empowerment program includes cognitive and Psychological Component. Cognitive Component will include discussion about Kidney disease and Dialysis with a Hemodialysis guide. Psychological component will include Integrative Counselling for both patients and their caregivers. For patients weekly 2 sessions for 3 weeks, for care givers weekly one session for 3 weeks. |
| Comparator Agent |
No intervention |
Patients will receive routine care provided in the Hospital |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Care givers
Primary caregivers(spouse or parent) of Patients who are undergoing hemodialysis
Care givers who are above the age of 18 years
Care givers who are willing to participate in the study
Patients
Patients who are undergoing maintenance Hemodialysis for more than 6 months
Patients above 18 years
Patients who have regular hemodialysis attendance
|
|
| ExclusionCriteria |
| Details |
Care givers of patients who are admitted in the ward and undergoing hemodialysis
Care givers being health care professionals
Patients who are critically ill during dialysis
Patients who are planning for Transplantation
Patients with active neurologic and Psychiatric problems
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life of patients undergoing Hemodialysis and care giver Burden |
Baseline Assessment will be done (Day 0), Post Intervention -Empowerment Program, Quality of Life and Care giver Burden will be assessed at 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence, Clinical Outcomes of patients undergoing Hemodialysis |
Baseline Assessment will be done (Day 0), Post Intervention -Empowerment Program, Adherence and Clinical outcomes will be measured at 4 weeks and 12 weeks |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Present
Study titled Lived Experience of patients of Patients undergoing Hemodialysis
and effect of Empowerment program on Quality of Life, Adherence, Clinical
Outcomes of patients and Care giver Burden uses a mixed method approach.
Objectives
- Explore the lived experiences of patients
undergoing Dialysis
- Evaluate the effect of Empowerment program on
Quality of Life, Adherence, Clinical outcomes of patients and Care giver
burden
- Correlate the Quality of Life,
Adherence, Clinical outcomes of patients and Care giver burden before and
after Empowerment program
Qualitative
aspect of Quality of Life will be explored using Phenomenological Approach. Quantitative aspect
will be will evaluate the effect of an empowerment
program on Quality of Life, Adherence, Clinical outcomes of patients and
Caregiver burden.100 patients and their caregivers will be involved in the study. Pre assessment will be done on day 0, Experimental Group will receive a 6 sessions of Empowerment program and post assessment will be done at 4 and 12 weeks post intervention. Control group will receive routine standard care
Conclusion
Identifying
and exploring the patient needs and
potential caregiver in the family of patient and established empowerment
programs to prepare them for the task to be carried out, mainly in the initial
phase of their activities will enhance the Quality of Life of Patients
undergoing Hemodialysis
|