| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anupamaaugustine3@gmail.com].
- 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.
- 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. |