| CTRI Number |
CTRI/2023/06/054273 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The benefit of educational session in changing knowledge, attitude and practice of foot care in diabetes patients |
|
Scientific Title of Study
|
Effectiveness of structured educational program in changing knowledge, Attitude and Practice of foot-care in Type -2 diabetes mellitus patients visiting Tertiary care Hospital of Sikkim: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rosila Luitel |
| Designation |
postgraduate student |
| Affiliation |
Sikkim Manipal college of Physiotherapy |
| Address |
sikkim, 5th mile tadong
east Sikkim, tadong, sikkim manipal university, Sikkim manipal college of pysiotherapy
East
SIKKIM
737102
India |
| Phone |
8710008246 |
| Fax |
|
| Email |
rosilaluitel34347@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambika lama |
| Designation |
lecturer |
| Affiliation |
sikkim manipal colledge of physiotherpay |
| Address |
sikkim, 5th mile tadong
east Sikkim, tadong, sikkim manipal university, Sikkim manipal college of pysiotherapy
East
SIKKIM
737102
India |
| Phone |
9686794059 |
| Fax |
|
| Email |
ambika.l@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rosila Luitel |
| Designation |
postgraduate student |
| Affiliation |
Sikkim Manipal college of Physiotherapy |
| Address |
sikkim, 5th mile tadong
east Sikkim, tadong, sikkim manipal university, Sikkim manipal college of pysiotherapy
East
SIKKIM
737102
India |
| Phone |
8710008246 |
| Fax |
|
| Email |
rosilaluitel34347@gmail.com |
|
|
Source of Monetary or Material Support
|
| RAMDAS PAI AND MRS.VASANTHI PAI UNIVERSITY RESEARCH FUND UNDER STUDENT PROPOSAL |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal University |
| Address |
5TH MILE, TADONG, EAST SIKKIM |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rosila Luitel |
Central Referral Hospital |
medicine out patient department department, 3rd floor,room number 5,5th mile, tadong,gantok, east sikkim
East
SIKKIM |
8710008246
rosilaluitel34347@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional research Committee |
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 |
NO ANY |
THE COMPARATOR GROUP WILL BE ASSESSED FOR KNOWLEGE, ATTUDE AND PRACTICE OF DIABETES FOOT CARE BUT WONT BE PROVIDE WITH EDUCATION SESSION. REASSESSMENT WILL BE DONE AFTER 4 WEEKS OF FIRST ASSESSMENT. |
| Intervention |
STRUCTURED EDUCATION SESSSION |
PRE-INTERVENTION ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE OF DIABETES FOOT CARE IN DIABETES MELLITUS PATIENTS.STRUCTURED EDUCATION SESSION CONTAINING TOTAL OF 10 MINUTE VIDEO SESSION, 5 MINUTE OF ONE TO ONE EDUCATIONAL SESSION AND EXERCISE DEMONSTRATION AND PROVIDING PHAMPHLET AND FOLLOW UP WITH ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE OF DIABETES FOOT CARE IN DIABETES MELLITUS AFTER 4 WEEKS.
THE COMPARATOR GROUP WILL BE ASSESSED FOR KNOWLEGE, ATTUDE AND PRACTICE OF DIABETES FOOT CARE BUT WONT BE PROVIDE WITH EDUCATION SESSION. REASSESSMENT WILL BE DONE AFTER 4 WEEKS OF FIRST ASSESSMENT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18 years
Both genders
Patients diagnosed with T2DM
|
|
| ExclusionCriteria |
| Details |
History of diabetes retinopathy
History of active foot infection
Comprehension problem
Neurological condition affecting cognition
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ASSESSMENT KNOWLEGE, ATTITUDE AND PRACTICE OF DIABETIC FOOT CARE |
KNOWLEGE, ATTITUDE AND PRACTICE OF DIABETIC FOOT CARE IN DAY ONE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ASSESSMENT KNOWLEGE, ATTITUDE AND PRACTICE OF DIABETIC FOOT CARE |
KNOWLEGE, ATTITUDE AND PRACTICE OF DIABETIC FOOT CARE IN 4 WEEKS POST INTERVENTION |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
28/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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
|
This study aims to assess the effectiveness of structured self-care educational regime in changing knowledge, attitude and practice of diabetes foot care in patient with type-2 diabetes mellitus of patients attending a tertiary care hospital of Sikkim. The study will also assess the feasibility and acceptance of the structured self- care educational in Sikkim population with type2 diabetes mellitus. |