| CTRI Number |
CTRI/2025/01/079745 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effectiveness of empowerment programme on health practices and self-efficacy among patients undergoing maintenance hemodialysis |
|
Scientific Title of Study
|
Effectiveness of empowerment programme on health practices and self-efficacy among patients undergoing maintenance hemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Choppa Adilakshmi |
| Designation |
IInd year M.Sc. Nursing |
| Affiliation |
KUHS |
| Address |
Govt. college of Nursing kottayam
Govt. college of Nursing kottayam
Kottayam
KERALA
686008
India |
| Phone |
9059148611 |
| Fax |
|
| Email |
lourderfts@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Choppa Adilakshmi |
| Designation |
PG Nursing |
| Affiliation |
Government College of Nursing |
| Address |
Govt. college of Nursing kottayam
Govt. college of Nursing kottayam
Kottayam
KERALA
686008
India |
| Phone |
9059148611 |
| Fax |
|
| Email |
lourderfts@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Smitha p.v |
| Designation |
Assistant professor |
| Affiliation |
Government College of Nursing |
| Address |
Govt. College of Nursing Kottayam
Govt. college of Nursing kottayam
Kottayam
KERALA
686008
India |
| Phone |
9895317590 |
| Fax |
|
| Email |
smitha.pv8@gmail.com |
|
|
Source of Monetary or Material Support
|
| This clinical trial is self-funded by me( Choppa Adilakshmi) and i do not have any external sources of monetary or material support. |
|
|
Primary Sponsor
|
| Name |
self - Choppa Adilakshmi |
| Address |
Govt.College of Nursing Kottayam |
| Type of Sponsor |
Other [self budget] |
|
|
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 |
| Choppa Adilakshmi |
Government Medical College Hospital |
Hemodialysis Units I and II of Nephrology department.
Kottayam
KERALA |
9059148611
lourderfts@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVT.COLLEGE OF NURSING, KOTTAYAM ISTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Empowerment programme |
video assisted teaching on health practices
Positive self talk-audio
Bensons relaxation technique-audio and
Rom exercises.
Has to practice daily twice for 3 weeks. |
| Comparator Agent |
Nil |
0 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and female patients undergoing maintenance hemodialysis who are
1. between the age of eighteen to seventy-five years
2. able to communicate in Malayalam or English
Patients undergoing maintenance hemodialysis
It refers to patients who are clinically diagnosed with end stage renal disease stage-V and are on hemodialysis, two to three times a week to support their life.
|
|
| ExclusionCriteria |
| Details |
Adult male and female Patients undergoing maintenance hemodialysis who are
1. with cognitive impairment
2. speech and hearing impairment
3. critically ill
4. renal transplant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome Name: Mean change in health practices score, Time- points:3 weeks
Outcome Name: Mean change in self-efficacy score, Time points:3 weeks
|
The outcome will be assessed at 3 weeks after the implementation of the empowerment programmme.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better health practice and enhanced self-efficacy |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/02/2025 |
| Date of Study Completion (India) |
12/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The primary purpose of this protocol is to evaluate the effectiveness of empowerment programme among patients undergoing maintenance hemodialysis. the study hypothesis is that empowerment programme will significantly improve health practices and self-efficacy compared to control there by providing a novel tratment option for patients with CKD. |