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CTRI Number  CTRI/2024/11/077269 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effect of self care management program on knowledge and practice regarding diabetics foot ulcer prophylaxis among patients with type2 diabetes mellitus in a tertiary care centre Alappuzha  
Scientific Title of Study   Effect of self care management programme on knowledge and practice regarding diabetic foot ulcer prophylaxis among patients with Type 2 Diabetes Mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anupama Augustian 
Designation  PG nursing student  
Affiliation  Kerala university of health sciences 
Address  Anupama Augustian Government college of nursing Vandanam po Alappuzha Kerala Medical surgical nursing department First floor Room number 2
Anupama Augustian Government college of nursing Vandanam po Alappuzha Kerala Medical surgical department First floor Room number 2
Alappuzha
KERALA
688005
India 
Phone  9544874880  
Fax    
Email  anupamaaugustine3@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Preemy Mathew A 
Designation  Associate professor 
Affiliation  Kerala university of health sciences  
Address  Mrs. Preemy Mathew A Associate professor Government college of nursing vandanam po Alappuzha Kerala Medical surgical department First floor Room number 1
Preemy Mathew A Government college of nursing Vandanam po Alappuzha Kerala Medical surgical department First floor Room number 1
Alappuzha
KERALA
688005
India 
Phone  9072118972  
Fax    
Email  preemygeorge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Preemy Mathew A 
Designation  Associate professor 
Affiliation  Kerala university of health sciences  
Address  Mrs. Preemy Mathew A Associate professor Government college of nursing Vandanam po Alappuzha Kerala Medical surgical department First floor Room number 1
Associate Professor Government college of nursing Vandanam po Alappuzha Kerala Medical surgical department First floor Room number 1
Alappuzha
KERALA
688005
India 
Phone  9072118972  
Fax    
Email  preemygeorge@gmail.com  
 
Source of Monetary or Material Support  
Government college of nursing ,vandanam po,680055,,Alappuzha ,kerala 
 
Primary Sponsor  
Name  Anupama Augustian 
Address  Government college of nursing,vandanam po ,680055,Alappuzha,kerala 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mrs Preemy Mathew A  Government TD medical college hospital,Vandanam po ,Alappuzha 688005,Kerala  Vandanam po Alappuzha Kerala General medicine wards Department of internal medicine Medicine ward number 11 and 12 Second floor Room number 11 and 12
Alappuzha
KERALA 
9072118972

Preemygeorge@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee,government college of nursing,vandanam po,Alappuzha,688005  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  EFFECT OF SELF CARE MANAGEMENT PROGRAMME ON KNOWLEDGE AND PRACTICE REGARDING DIABETIC FOOT ULCER PROPHYLAXIS AMONG PATIENTS WITH TYPE 2 DIABETES MELLITUS  60 patients with Type 2 diabetes mellitus and those who fulfill the inclusion and exclusion criteria will be selected for the study, 30 in control group and 30 in experimental group. The investigator will approach the subjects, explain the study purpose, establish rapport, and obtain informed consent from the subjects. On the first day pretest for the control group will be done. Socio personal data and clinical data will be collected using socio personal data sheet. A practice checklist will be used to assess the practice regarding diabetic foot ulcer prophylaxis in the pretest. A structured knowledge questionnaire will be used to collect knowledge regarding diabetic foot ulcer prophylaxis.Control group will receive the conventional treatment as per the hospital protocol. Post test will be conducted on the 15th day. On the first day,pre test for the experimental group will be done. the socio-personal data and clinical data will be collected using a socio-personal and clinical data sheet. A practice checklist will be used to assess the practice regarding diabetic foot ulcer prophylaxis in the pretest .A structured knowledge questionnaire will be used to collect knowledge regarding diabetic foot ulcer prophylaxis .Thereafter, the group will receive a self-care management program, which includes an educational session regarding diabetic foot ulcer prophylaxis. The educational session will include diabetic foot ulcers, risk factors, early manifestations, and healthy foot care practices, delivered through the lecture method for a duration of 15 minutes as an individual session. This will be followed by a demonstration of foot ulcer prophylaxis practices, which include foot examination and practice regarding daily foot care, given for a duration of 20 minutes for each individual. Doubts regarding the self-care management program will be cleared by the researcher. Caregivers will also be motivated and reinforced to supervise these self-care management programs at home. On the day of discharge, patients are motivated to follow the foot care prophylaxis practice daily at home. They are provided with a practice diary to record their performance every day. An information booklet will be given to the group regarding diabetic foot ulcer prophylaxis practices. Reinforcements will be given via phone call every day by the investigator. The study will be conducted when you are admitted in the medicine wards of Govt. TDMCH, Vandanam for the treatment. A post-test will be conducted on the 15th day at OPD, when the patients came for follow up after the intervention. The total duration of data collection will be 30 minutes. The collected data will be organized, tabulated, analysed, and interpreted using descriptive and inferential statistics. 
Comparator Agent  No intervention   No intervention  
 
Inclusion Criteria  
Age From  40.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  Adult males and female with a diagnosis of type 2 diabetes mellitus
- who are willing to participate
- who are able to understand Malayalam
- Type 2 Diabetes Mellitus for a duration of two years
 
 
ExclusionCriteria 
Details 
Patients with Type 2 Diabetes Mellitus who are:

- Acutely ill 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effect of self-care management programme on knowledge regarding diabetic foot ulcer prophylaxis among patients with Type 2 Diabetes Mellitus.
 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the effect of self-care management programme on practice regarding diabetic foot ulcer prophylaxis among patients with Type 2 Diabetes Mellitus  7days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/12/2024 
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="0"
Months="1"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anupamaaugustine3@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

60 patients with Type 2 diabetes mellitus and those who fulfill the inclusion and exclusion criteria will be selected for the study, 30 in control group and 30 in experimental group. The investigator will approach the subjects, explain the study purpose, establish rapport, and obtain informed consent from the subjects.

On the first day pretest for the control group will be done. Socio personal data and clinical data will be collected using socio personal data sheet. A practice checklist will be used to assess the practice regarding diabetic foot ulcer prophylaxis in the pretest. A structured knowledge questionnaire will be used to collect knowledge regarding diabetic foot ulcer prophylaxis.Control group will receive  the conventional treatment as per the hospital protocol. Post test will be conducted on the 15th day.

On the first day,pre test for the experimental group will be done. the socio-personal data and clinical data will be collected using a socio-personal and clinical data sheet. A practice checklist will be used to assess the practice regarding diabetic foot ulcer prophylaxis in the pretest .A structured knowledge questionnaire will be used to collect knowledge regarding diabetic foot ulcer prophylaxis .Thereafter, the group will receive a self-care management program, which includes an educational session regarding diabetic foot ulcer prophylaxis.

The educational session will include diabetic foot ulcers, risk factors, early manifestations, and healthy foot care practices, delivered through the lecture method for a duration of 15 minutes as an individual session.

This will be followed by a demonstration of foot ulcer prophylaxis practices, which include foot examination and practice regarding daily foot care, given for a duration of 20 minutes for each individual. Doubts regarding the self-care management program will be cleared by the researcher. Caregivers will also be motivated and reinforced to supervise these self-care management programs at home.

On the day of discharge, patients are motivated to follow the foot care prophylaxis practice daily at home. They are provided with a practice diary to record their performance every day. An information booklet will be given to the group regarding diabetic foot ulcer prophylaxis practices. Reinforcements will be given via phone call every day by the investigator. The study will be conducted when you are admitted in the medicine wards of Govt. TDMCH, Vandanam for the treatment.

A post-test will be conducted on the 15th day at OPD, when the patients came for follow up after the intervention. The total duration of data collection will be 30 minutes. The collected data will be organized, tabulated, analysed, and interpreted using descriptive and inferential statistics.

 
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