| CTRI Number |
CTRI/2025/09/095266 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nurse led Intervention ] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of nurse-led teaching on knowledge and self-care practices in patients with type 2 diabetes in rural Jodhpur |
|
Scientific Title of Study
|
Effect of nurse-led intervention on knowledge and self-care activities regarding type 2 diabetes mellitus among patients with type 2 diabetes mellitus at a selected rural area of Jodhpur: A Quasi Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patel Drashti Sureshbhai |
| Designation |
M.Sc Nursing Student |
| Affiliation |
All India Institute of Medical Science , Jodhpur, Rajasthan, India |
| Address |
Seminar room 3, College of Nursing, AIIMS Jodhpur,
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni,Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09664849826 |
| Fax |
|
| Email |
drashtipatel383l@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gomathi Arumugam |
| Designation |
Associate Professor, College of Nursing, AIIMS, Jodhpur |
| Affiliation |
All India Institute of Medical Science , Jodhpur, Rajasthan, India |
| Address |
College of Nursing, AIIMS Jodhpur, Basni Industrial Area,
Rajasthan Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9843561949 |
| Fax |
|
| Email |
murugang998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gomathi Arumugam |
| Designation |
Associate Professor, College of Nursing, AIIMS, Jodhpur |
| Affiliation |
All India Institute of Medical Science , Jodhpur, Rajasthan, India |
| Address |
College of Nursing, AIIMS Jodhpur, Basni Industrial Area,
Rajasthan Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9843561949 |
| Fax |
|
| Email |
murugang998@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gomathi Arumugam |
Rural Health Training Centre (RHTC), Keru, Jodhpur |
Rural Health Training Centre, Keru Village, Jodhpur, Rajasthan-3402024
Jodhpur
RAJASTHAN |
9843561949
murugang998@gmail.com |
| Patel Drashti Sureshbhai |
Rural Health Training Centre (RHTC), Keru, Jodhpur |
Rural Health Training Centre, Keru Village, Jodhpur, Rajasthan-3402024
Jodhpur
RAJASTHAN |
09664849826
drashtipatel383l@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, AIIMS, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
control group received standardized routine care regarding type 2 diabetes mellitus |
| Intervention |
Knowledge and self care activity among type 2 diabetes |
6 WEEK
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 30-80 years
2. Diagnosed with type 2 Diabetes at-least one year before the study began
3. Available during the data collection period
4. Willing to participate and provide informed consent
Can understand hindi or english language
|
|
| ExclusionCriteria |
| Details |
1. Patients with type 1 diabetes mellitus
2. Patients with any life-threatening disease
3. Advanced cardiovascular diseases (e.g., heart failure, recent myocardial infarction, severe arrhythmias)
4. End-stage liver disease, Severe respiratory diseases (e.g., chronic obstructive pulmonary disease (COPD) with respiratory failure)
Active malignancies (e.g., metastatic cancer, undergoing chemotherapy)
Neurological disorders (e.g., advanced stroke, severe neurodegenerative diseases like ALS)
Severe infections (e.g., sepsis, advanced tuberculosis)
5. Diagnosis of kidney disease
6. Gestational diabetes
7. Patients with cognitive impairment or psychiatric illness affecting participation
Unwilling to give informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge and self care activity regarding type 2 diabetes mellitus |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nill |
Nill |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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
|
Aim of the studyEvaluate the effect of nurse-led interventions on knowledge and self-care activities regarding type 2 diabetes mellitus among patients with type 2 diabetes mellitus at a selected rural area of Jodhpur. Objectives1. To evaluate the effect of nurse-led intervention on knowledge and self-care activities regarding type 2 diabetes mellitus among patients with type 2 diabetes mellitus in intervention and control group. 2. To determine the correlation between knowledge and self-care activities regarding type 2 diabetes mellitus among patients with type 2 diabetes mellitus. 3. To find the association of knowledge and self-care activities regarding type 2 diabetes mellitus among patients with type 2 diabetes mellitus with selected sociodemographic variables. Hypotheses:· There will be no significant difference in knowledge and self-care activities scores among patients with type 2 diabetes mellitus before and after the nurse-led intervention. · There will be no significant correlation between knowledge and self-care activities scores among patients with type 2 diabetes mellitus. |