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CTRI Number  CTRI/2021/03/031629 [Registered on: 01/03/2021] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Impact of an Educational Module on the Knowledge and Practice of Foot Self Care in Patients with Diabetes 
Scientific Title of Study   Impact of an ‘Interprofessional Collaborative (IPC)’ Module on the Knowledge and Practice of Foot Self Care in Patients with Diabetes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sushma Prabhath 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal, Karnataka, India, Zip code: 576104

Udupi
KARNATAKA
576104
India 
Phone  09880895097  
Fax    
Email  sushma.rk@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushma Prabhath 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal, Karnataka, India, Zip code: 576104

Udupi
KARNATAKA
576104
India 
Phone  09880895097  
Fax    
Email  sushma.rk@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sushma Prabhath 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anatomy Kasturba Medical College Manipal Manipal Academy of Higher Education, Manipal, Karnataka, India, Zip code: 576104

Udupi
KARNATAKA
576104
India 
Phone  09880895097  
Fax    
Email  sushma.rk@manipal.edu  
 
Source of Monetary or Material Support  
Self funded project that will be carried out at the Centre for Diabetic Foot Care and Research (CDFCR), Kasturba Hospital Manipal 
 
Primary Sponsor  
Name  Dr Sushma Prabhath 
Address  Department of Anatomy, Kasturba Medical College Manipal, Manipal Academy of Higher Education Manipal, Karnataka, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushma Prabhath  Kasturba Hospital, Manipal  Visitors Lounge for patient recruitment and Class room 1 for the educational intervention at the Centre for Diabetic Foot Care and Research (CDFCR)
Udupi
KARNATAKA 		 09880895097

sushma.rk@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Intervention  Implementation of the educational module as an Intervention: Pamphlets (T/L methods) on diabetic foot & its risks, proper foot care will be given to the patients after participating in the study. Patients will be educated/counseled on proper self-Management of diabetic foot after the pre-test. Educational videos on proper practices of diabetic foot care will be displayed WhatsApp group- “Diabetic foot care” will be created, including the core IP team faculty and study participants, after seeking appropriate consent/ permission. The relevant information on foot self-care (articles, educational videos, snapshots, etc.) will be shared routinely (At least once a week). An active discussion in the group will also be encouraged. Frequent reminders about self-care and management of diabetic foot will be sent in the groups. If the participants are from remote areas and are not comfortable using WhatsApp, the necessary information, i.e., details about newspaper articles, television/radio shows, would also be shared through telephonic conversations. Newspaper articles on diabetic foot care practices will be written and published in the regional newspapers; Television and radio (interviews) programs (i.e., Doctor speaks- Health in your hands) will be organized. A link to such sessions will be shared in the WhatsApp group. Simulation sessions/Role plays/ street plays stressing on proper self-Management of diabetic foot in diabetes will be carried out by the students of the IP team. The recorded version of the same will be made available in the WhatsApp group.  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  The patients with diabetic neuropathy will be recruited for the study. Patients with type 2 diabetes of any duration will be considered. The study participants will be recruited after the foot assessment from the Centre for Diabetic Foot Care and Research (CDFCR) Department of Physiotherapy, Kasturba Hospital Manipal.
They must be able to read, comprehend, and understand Kannada or English, and consent to participate in the study. It would be ideal if the participants possess smartphones and are comfortable using WhatsApp.
 
 
ExclusionCriteria 
Details  Patients with type 1 diabetes, impaired fasting glucose, impaired glucose tolerance, and gestational diabetes will be excluded from the study. Patients who have developed diabetic foot ulcers will also not be considered. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Forming a well-educated and motivated interprofessional team that would be actively involved in teaching the good practices of self-Management of diabetic foot among patients with diabetes
2.Increase in the knowledge & practice of self-Management of foot among the patients with diabetes
 		 0ne to three years 
 
Secondary Outcome  
Outcome  TimePoints 
Decreased rate of admissions of patients with complaints of the diabetic foot into the hospital
Reduced rate of amputations and mortality among patients with diabetic foot

 		 5 to 15 years 
 
Target Sample Size   Total Sample Size="291"
Sample Size from India="291" 
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)   01/03/2021 
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="3"
Months="3"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1Formation of an Interprofessional (IP) team:

An IP team has been formulated including faculty. The faculty are from the disciplines/professions of Anatomy, Medical specialties such as General Medicine, Endocrinology, Surgery, Physiotherapy, Nursing, and Diet & Nutrition of MAHE. The IP team would function in co-ordination with the ‘Centre for Diabetic Foot Care and Research’ (CDFCR), MAHE, Manipal.

The core members of the IP team (faculty) will have frequent meetings and focused group discussions to plan, develop and implement the educational module, identify and share their roles and responsibilities.

Role of the IP team:

Faculty from the departments of:

Anatomy: Development of the module, assisting in the teaching-learning (T/L) activities and organizing community outreach programs

Medical specialties such as General Medicine, Endocrinology and Surgery

Development of the module, T/L activities, Examining the patients and assisting in recruiting them to the study, Counselling regarding diabetes and its effects

·Diabetic foot care specialist, Physiotherapy and Orthotist: Development of the module, T/L activities, educating patients regarding the proper practices of foot care.

Nursing: Development of the module, assisting in the T/L activities

·Diet & Nutrition: Development of the module, T/L activities, educating patients regarding the role of diet & nutrition in the management of diabetes. 

Students (Undergraduates) from Medicine, Nursing, Physiotherapy:

· If required will be, involved in conducting role plays/ street plays as a part of the planned educational intervention. The students will be briefed-educated about self-management of diabetic foot - knowledge and practices by the IP team and encouraged to come up with ideas for role play relevant to the theme, i.e., diabetic foot care. The students’ time constraints will be carefully looked into and the students’ involvement in the outreach programs will be planned based on their feasibility.

Development of an IPC module: The IP team including the faculty will work on the development of an IPC module. Focused group discussions will be carried out to have a consensus on the following:

· Aims and learning outcomes of the proposed IPC module

· Course content, developing the educational resources: pamphlets, videos

· Teaching-learning (T/L) methods and resources

·  Frame work for the action plan/ follow-up that would convert the knowledge into practice

· Assessment

· Timeline for the implementation and assessment of the module

· Monitoring and review

Study design: Non-Experimental-Interventional study

Study Plan:

The study will be conducted in two phases:

Phase I (Current Plan): Increase in the knowledge and practices of self-Management of foot among patients with diabetes will be assessed.

Phase II (Future plan): Community outreach Programs, Conducting medical camps etc

Phase I (Short-term):

The phase 1 part of the study will be conducted for one year among the patients with diabetes at CDFCR, Kasturba Hospital, Manipal, Karnataka, India. The study will be conducted after approval by the Institutional Ethics Committee (IEC) via the IEC interface.

The study will be conducted using a detailed Questionnaire. Appropriate permissions have already been taken for its use (Annexures).

The questionnaire will comprise of three parts:

Part 1: Demographic Details (Age, Sex, Education, Socio-economic status) and Diabetic profile (Magbanua & Lim-Alba, 2017)

Part 2: Knowledge of Foot-care (developed by Hasnain and colleagues) (Hasnain et al., 2009)

Part 3: Nottingham Assessment of Functional Foot Care (Lincoln et al., 2007)

The questionnaires will be translated to the local vernacular language, i.e., Kannada, to ensure that these would be fully understood by the patients. Back to back-translation (i.e., English-Kannada-English) will be carried out to check the appropriate phrasing of the Kannada translated questions. The IP team will evaluate the content validity of the translated questionnaires, while ten patients will be asked to assess the face validity.

To ensure a high response rate, the principal investigator will conduct a recruitment process and give out the participant information sheet (PIS) that clearly explains the purpose of the study, its significance, its risks and benefits, and the personal information needed. Further, it will also be emphasized that the results of this study will be used to improve how healthcare providers may improve diabetes education on proper self-Management of foot. The PIS will be distributed in both English and Kannada.  The patients will then be recruited only after obtaining informed consent. 

Pre-test: The respondents will be encouraged to complete all the questionnaires to measure the level of their knowledge and practice of self-Management of diabetic foot before the educational intervention.

Implementation of the educational module as an Intervention:

· Pamphlets (T/L methods) on diabetic foot & its risks, proper foot care will be given to the patients after participating in the study.

· Patients will be educated/counseled on proper self-Management of diabetic foot after the pre-test.

· Educational videos on proper practices of diabetic foot care will be displayed

· WhatsApp group- “Diabetic foot care” will be created, including the core IP team faculty and study participants, after seeking appropriate consent/ permission. The relevant information on foot self-care (articles, educational videos, snapshots, etc.) will be shared routinely (At least once a week). An active discussion in the group will also be encouraged. Frequent reminders about self-care and management of diabetic foot will be sent in the groups.

If the participants are from remote areas and are not comfortable using WhatsApp, the necessary information, i.e., details about newspaper articles, television/radio shows, would also be shared through telephonic conversations.

· Newspaper articles on diabetic foot care practices will be written and published in the regional newspapers; Television and radio (interviews) programs (i.e., Doctor speaks- Health in your hands) will be organized. A link to such sessions will be shared in the WhatsApp group.

Simulation sessions/Role plays/ street plays stressing on proper self-Management of diabetic foot in diabetes will be carried out by the students of the IP team. The recorded version of the same will be made available in the WhatsApp group.

Post-test: Three months following the educational intervention, the participants will be invited to revisit the CDFCR and the same questionnaire will be redistributed to the same participants to reassess the change/ improvement in the level of knowledge and practice of diabetic foot self-care among these patients.

The questionnaire will also be digitally shared to the participants, unable to revisit the center due to unavoidable circumstances.

Focused group discussions, one-to one telephonic/ in person interviews will also be conducted to access the impact of the planned educational intervention. The conversations in the WhatsApp group “Diabetic foot care” will also be analyzed.

The observations will be documented and considered for publication. With a purpose to further extend the study to phase II, attempts will be made to apply for extramural funding.


 
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