| CTRI Number |
CTRI/2025/08/092837 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess if planned teaching helps diabetic patients understand how to detect kidney problems early." |
|
Scientific Title of Study
|
Assess the effectiveness of planned teaching on knowledge regarding strategies for early detection of diabetic nephropathy among diabetic patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Bhokare |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Dept of Medical Surgical Nursing ,1st Floor SRMMCON Building, Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709116011 |
| Fax |
|
| Email |
nikitabhokare530@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRuchira Ankar |
| Designation |
Professor |
| Affiliation |
Dattta Meghe Institute of Higher Education and Research |
| Address |
Dept of Medical surgical Nursing, 1st Floor SRMMCON Building, Sawangi( Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira.shende@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchira Ankar |
| Designation |
Professor |
| Affiliation |
Dattta Meghe Institute of Higher Education and Research |
| Address |
Dept of Medical surgical Nursing, 1st Floor SRMMCON Building, Sawangi( Meghe) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira.shende@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dattta Meghe Institute of Higher Education and Research Sawangi Meghe Wardha 442001 |
|
|
Primary Sponsor
|
| Name |
Dattta 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 |
| Nikita Bhokare |
Smt. Radhikabai Meghe Memorial College of Nursing |
Dept of Medical Surgical Nursing ,1st Floor SRMMCON Building, Sawangi(Meghe) Wardha
Wardha
MAHARASHTRA |
07709116011
nikitabhokare530@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe 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: E132||Other specified diabetes mellituswith kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Planned Teaching on Early detection of diabetic nephropathy |
Participants received a planned teaching programmed on strategies for early detection of diabetic nephropathy consisting of three 40-minute sessions delivered over two weeks (total contact time 120 minutes). A single 30-minute booster session at 4 weeks reinforced key points. Knowledge was measured at baseline (pre-test), within 1 week after the final session (immediate post-test), and at 3 months post-intervention to assess retention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were visited at hospital
Those diabetic patient were willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Diabetic patients from general population |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to show a significant improvement in the knowledge scores of diabetic patients regarding strategies for early detection of diabetic nephropathy, with higher post-test and follow-up test scores compared to pre-test scores, indicating the effectiveness of the planned teaching programme. |
Knowledge assessment will be conducted at three time points: pre-test (before the intervention), immediate post-test (within one week after the final teaching session) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
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
|
INTRODUCTION
Diabetes mellitus is a group of
metabolic disorders that can result from either an absolute or relative lack of
the digestive hormone insulin or from body cell resistance to using the
insulin that is there. In practically every country in the world, diabetes
mellitus a disease that is silent, is now acknowledged as one of the public
health risks that is expanding the fastest. Every 5th person who suffers from
diabetes in the world today is an Indian. BACKGROUND
Diabetes
is a condition that impacts millions of individuals worldwide each year. The
patient is the key to any diabetic treatment success. It is thought that
self-care is essential to managing diabetes mellitus. The patient’s knowledge
and attitude regarding self-care activities might be enhanced by appropriate health
education. OBJECTIVES
1. Assess
thThe present study aimed to assess the effectiveness of a planned teaching programme on knowledge regarding strategies for early detection of diabetic nephropathy among diabetic patients. The findings revealed a significant improvement in the post-test knowledge scores compared to the pre-test scores. This indicates that the planned teaching programme was effective in enhancing the participants’ understanding of early warning signs, risk factors, and preventive strategies for diabetic nephropathy.e existing knowledge regarding diabetic nephropathy among
diabetic patients.
2. Assess
the effectiveness of planned teaching on knowledge regarding diabetic nephropathy among
diabetic patients.
3. To
associated the posttest knowledge score with selected demographic variables.
METHODOLOGY A quasi-experimental one-group pretest and posttest design was used. A sample of 125 diabetic patients was selected using convenience sampling from Wardha. Data was collected using a structured questionnaire assessing the knowledge of diabetic patients. A planned teaching session was conducted, followed by a post-test to evaluate its effectiveness. Statistical analysis using SPSS 27.0 RESULTS Findings indicated a significant improvement in knowledge scores post-intervention. Demographic variables such as age, education level type of diabetes showed a positive corelation with post test scores. CONCLUSION The present study aimed to assess the effectiveness of a planned teaching programme on knowledge regarding strategies for early detection of diabetic nephropathy among diabetic patients. The findings revealed a significant improvement in the post-test knowledge scores compared to the pre-test scores. This indicates that the planned teaching programme was effective in enhancing the participants’ understanding of early warning signs, risk factors, and preventive strategies for diabetic nephropathy. Keywords: Diabetic Nephropathy, Early Diagnosis
M
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