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CTRI Number  CTRI/2020/03/024203 [Registered on: 24/03/2020] Trial Registered Prospectively
Last Modified On: 17/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   A study to assess few nursing based interventions, given together in a period of time, for influencing biological and psychological changes for people with Diabetes in community 
Scientific Title of Study   Effectiveness of nurse Led intervention in terms of maintenance of anthropometric features, biophysical profiles, self-care activities and quality of life among adults living with diabetes in selected villages of Khurda, Odisha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sailabala Mohanty 
Designation  Assistant professor & P.G Student 
Affiliation  Siksha O Anusandhan University 
Address  Room No. 201, Faculty of Nursing, SUM Nursing College, Siksha O Anusandhan University, Kalinga Nagar, Ghatikia

Khordha
ORISSA
751030
India 
Phone  9439449891  
Fax    
Email  mohantysailabala85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sushma Kumari Saini 
Designation  Lecturer and Guide 
Affiliation  National Institute of Nursing Education 
Address  Second level (room no. 211) National Institute of Nursing Education, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9888038248  
Fax    
Email  sushmadrsaini@gmail.com  
 
Details of Contact Person
Public Query  
Name  SAILABALA MOHANTY 
Designation  Assistant Professor 
Affiliation  Siksha O Anusandhan University 
Address  SUM Nursing College, Siksha O Anusandhan University, Kalinga Nagar, Ghatikia

Khordha
ORISSA
751030
India 
Phone  9439449891  
Fax    
Email  mohantysailabala85@gmail.com  
 
Source of Monetary or Material Support  
Rural Health Training Center, IMS & SUM Hospital, Jamujhuri, Khorda, Orissa 
 
Primary Sponsor  
Name  Sailabala Mohanty 
Address  Siksha O Anusandhan University, Kalinga Nagar, Bhubaneswar, Orissa - 751030 
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 
Sailabala Mohanty  Rural Health Training Centre, IMS and SUM Hospital  RHTC, IMS and SUM Hospital, Jamujhuri
Khordha
ORISSA 		 9439449891

mohantysailabala85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical sciences and SUM Hospital  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  NIB-FAME  A nurse led intervention Bundle is proposed with Family Education on enhancing knowledge regarding Diabetes Mellitus along with Motivational Interviewing and Mindfulness Eating for adhering with self care activities, which in turn improves the quality of life for people living with Diabetes. 
Comparator Agent  Routine Care   The control group participants will be continuing the routine treatment procedures, ordered by their concerned physicians. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Clinical diagnosis of Type 2 Diabetes Mellitus, more than 6 months
2) Both genders, between 18-65 years of age group
3) not planning to move away from the community in the next 6 Months
4) people who are able to read and understand Oriya language 
 
ExclusionCriteria 
Details  1) not willing to give informed consent
2) pregnant
3) severe mental illness
4) Type 2 diabetes mellitus with complication
5) who are unwilling to undergo routine treatment
6) who are undergoing any other trial 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Self care activities  4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of Life  4 weeks
12 weeks 
Depression   4 weeks
12 weeks 
Problem areas in Diabetes  4 weeks
12 weeks 
Fasting Blood Sugar  12 Weeks 
Self Care Activities  12 weeks 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   26/03/2020 
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="10"
Days="0" 
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)?  

Brief Summary   This study is undertaken, for the completion of the Ph.D. in Nursing Thesis. The study is aimed to assess the effectiveness of a nurse led intervention which proposes to include, primarily, Motivational interviewing, mindful eating and family education on people with Type 2 Diabetes Mellitus, in order to, enhance the self care activities of the participants. The study also plans to assess the HbA1c, Depressive symptoms, quality of life and problems areas of the participants. The researcher also takes, certain arthropometric features, like height, weight, waist circumference of the participants, as well as, a brief participant experience regarding intervention. 
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