| CTRI Number |
CTRI/2025/07/091730 [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
|
Preventive
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how well health education helps people with diabetes and high blood pressure understand the risks of stroke and how to prevent it. |
|
Scientific Title of Study
|
Effectiveness of planned teaching on knowledge regarding risk factors and prevention of stroke among diabetic and hypertensive patients in selected hospital of Wardha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Pallavi Patil |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7666319430 |
| Fax |
|
| Email |
pallavi.msn.in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Aarti Raut |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aarti Raut |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha
MAHARASHTRA
442001
India |
| Phone |
9673771592 |
| Fax |
|
| Email |
aratiraut15714@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe institute of Higher Education and Research Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher 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 |
| Dr Pallavi Patil |
Acharya Vinoba Bhave Rural Hospital |
Department of Medical Surgical Nursing Smt. Radhikabai Meghe Memorial College of Nursing Sawangi Meghe Wardha.
Wardha
MAHARASHTRA |
7666319430
pallavi.msn.in@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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A planned teaching on identification of risk factors and prevention of stroke |
Effectiveness of planned teaching on risk factors and prevention of stroke among hypertensive and diabetic patients. The duration of intervention will be 6 hours. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients who are willing to participate in the structured planned teaching program and attend the required sessions
2 Participants diagnosed with diabetes and hypertension
3 Adults of both genders above 21 years age
4 Individual able to comprehend and respond to the educational material provided
|
|
| ExclusionCriteria |
| Details |
1 Patients who have previously received structured planned teaching on prevention of stroke or have participated in similar educational programme.
2 Those unwilling or unable to attend structured teaching sessions
3 Patients with severe cognitive impairment or communication barriers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in knowledge score regarding risk factors and prevention of stroke among diabetic and hypertensive patients, as measured by a structured knowledge questionnaire |
Assessment will be done at 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
| |
|
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
15/08/2025 |
| 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 Yet Recruiting |
| 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
|
Abstract:
This study evaluates the effectiveness of planned teaching on knowledge regarding risk factors and prevention of stroke among diabetic and hypertensive patients in a selected hospital of Wardha. A structured educational intervention was provided to patients, and their knowledge was assessed at three time points: before the intervention (pre-test), immediately after (post-test), and four weeks later (follow-up). The findings indicated a significant improvement in knowledge scores immediately following the teaching session, with sustained retention at follow-up. The results highlight the importance of targeted educational programs in enhancing stroke awareness and prevention among high-risk patients. |