| CTRI Number |
CTRI/2025/07/091695 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on how well the teach-back method helps people on regular dialysis learn about their treatment, feel confident, and take care of themselves better. |
|
Scientific Title of Study
|
Assess the effectiveness of teach back method strategy on hemodialysis-related knowledge,self efficacy, and self management among patients receiving maintainance 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 |
Rupali warghane |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing ,1st floor SRMMCON building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
07020018549 |
| Fax |
|
| Email |
rupalivinodzade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruchira Ankar |
| Designation |
Head of department ,Medical Surgical Nursing |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing ,1st floor SRMMCON building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchira Ankar |
| Designation |
Head of department ,Medical Surgical Nursing |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing ,1st floor SRMMCON building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Education and Research, Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| 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 |
| Rupali warghane |
Acharya Vinoba Bhave Rural Hospital |
Department of Nephrology Ward no 29, 3rd floor, Acharya Vinoba Bhave Rural Hospital Sawangi Meghe
Wardha
MAHARASHTRA |
7020018549
rupalivinodzade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1. Those patients undergoing haemodialysis are able to speak as well as write in Marathi
2. Those patients undergoing hemodialysis are available during the data collection period
|
|
| ExclusionCriteria |
| Details |
Those patients undergoing hemodialysis are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Teach-Back intervention, the self-efficacy and self-management
level of patients receiving MHD were significantly improved. |
Assessment will be done at 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Patients undergoing maintenance haemodialysis (MHD) require comprehensive knowledge and strong self-management skills to adhere to complex treatment regimens. The teach-back method, a patient-centered educational strategy, has gained attention for its potential to enhance understanding and engagement in chronic disease management. Objective: This study aims to assess the effectiveness of the teach-back method in improving haemodialysis-related knowledge, self-efficacy, and self-management behaviors among patients receiving MHD. Methods: A structured educational intervention based on the teach-back technique was implemented among MHD patients in selected dialysis centers. Participants were asked to restate critical information on topics such as diet, fluid management, medication adherence, and vascular access care. Pre- and post-intervention assessments were conducted using validated tools to measure knowledge levels, self-efficacy, and self-management practices. |