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CTRI Number  CTRI/2019/02/017589 [Registered on: 12/02/2019] Trial Registered Prospectively
Last Modified On: 07/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of group-based diabetes self-management education (DSME)package on self-care activities,diabetic control, and quality of life among diabetic patients. 
Scientific Title of Study   A Randomized Controlled Trial to assess the Effectiveness of Group-Based Diabetes Self-Management Education(DSME) program on Glycemic Control, Self-Care Efficacy and Quality of life in individuals with Type-2 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 Farishta Hannah D Singh 
Designation  MD student 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine Hamdard Institute of Medical Sciences and Research Jamia Hamdard

South
DELHI
110062
India 
Phone  8377048314  
Fax    
Email  farishtasingh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Rambha Pathak 
Designation  HOD and Guide 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine Hamdard Institute of Medical Sciences and Research Jamia Hamdard

South
DELHI
110062
India 
Phone  8826843180  
Fax    
Email  rambha.pathak@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Rambha Pathak 
Designation  HOD and Guide 
Affiliation  Hamdard Institute of Medical Sciences and Research 
Address  Department of Community Medicine Hamdard Institute of Medical Sciences and Research Jamia Hamdard

South
DELHI
110062
India 
Phone  8826843180  
Fax    
Email  rambha.pathak@gmail.com  
 
Source of Monetary or Material Support  
HAHC Hospital, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi- 110062 
Rural field practice area,Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, Madanpur Khadar, Delhi-110076 
Urban field practice area,Hamdard Institute of Medical Sciences and Research, Jamia Hamdard, Pul Prehladpur, Delhi-110044 
 
Primary Sponsor  
Name  Hamdard Institute of Medical Sciences and Research 
Address  Hamdard Nagar Jamia Hamdard New Delhi 110062 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Farishta Singh  Field Study area  Department of Community Medicine Hamdard Institute of Medical Sciences and Research Jamia Hamdard
South
DELHI 
8377048314

farishtasingh@gmail.com 
Dr Farishta Singh  HAHC Hospital  Department of Medicine, HAHC Hospital, Hamdard Institute of Medical Sciences and Research Jamia Hamdard
South
DELHI 
8377048314

farishtasingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee  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  Diabetes Self Management Education Program(DSME)  The intervention group will receive DSME along with routine care The components of the designed intervention include Dietary targets Physical activity targets Glucose self monitoring Foot hygiene Coping with diabetes related complications and Adherence to medication regimen. This intervention program will be delivered by a single educator, in a group session consisting of 6-7 members, for 30 minutes, once a month. Totally, 6 group sessions will be conducted for each group over 6 months (May-October). The entire study period will be for 1 year. 
Comparator Agent  Routine Diabetes care for the Control group  The control group members will receive the usual care which includes Blood sugar testing Medical and nursing physical examinations and Medications follow up 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Documented physician diagnosed type 2 diabetes for atleast 6 months
Ability and willingness to provide informed consent (English or Hindi)
No plans to move out of the area within the 12 month study period
 
 
ExclusionCriteria 
Details  Patients of Type 1 Diabetes
Patients of Gestational Diabetes
Patients having severe complications – like retinopathy or stroke
Any use of glucocorticoid therapy within the past 3 months
Patients currently participating in a cardiac rehabilitation or formal weight loss programme 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Glycemic Control and
Diabetes Self Care Activities 
At baseline and
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Diabetes self-efficacy
 
At baseline and
6 months 
Cardiovascular risk factor assessment  At baseline and
6 months 
Quality of life  At baseline and
6 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   01/03/2019 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   no Publications done yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Diabetes has increasingly become a major health problem worldwide. India hasn’t been far behind, having the second highest prevalence of diabetes, in advancing to 72·0 million prevalent cases of diabetes in 2017, as compared with 26·0 million in 1990. The development of complications affects the quality of life in these individuals. Episodes of hypoglycaemia, fear of hypoglycaemia, change in life style and fear of long term consequences may lead to reduced health-related quality of life (HRQoL).  Diabetes mellitus is a chronic disease that can affect all aspects of life. 

Diabetes self-management education (DSME) is recognized as a fundamental component of diabetes care. and it is believed that improving patient self-efficacy is a critical pathway to improved self-management  The goal of DSME is to help patients acquire the knowledge, information, self-care practices, coping skills, and attitudes required for the effective self-management of their diabetes. Several reviews and meta-analyses have found DSME interventions to have a positive impact on diabetes-related health and psychosocial outcomes, specifically increasing diabetes-related knowledge and improving blood glucose monitoring, dietary and exercise habits, foot care, medication taking, coping skills, and glycemic control. 

The proposed study will be conducted in the health centres of the field practice areas under the Department of Community Medicine, Hamdard Institute of Medical Sciences and Research(HIMSR) and the Diabetic clinic, Department of  Medicine, HAHC Hospital, HIMSR.

The proposed study will be a Randomized controlled trial. A total of 200 patients (diagnosed with type-2 diabetes mellitus will be randomized into two groups (100 patients each).

A baseline assessment of knowledge, self care activities (by using SDSCA questionnaire) , Diabetes self-care efficacy( by using Diabetes Management Self-Efficacy Scale (DMSES)), Quality of life ( by using DMQoL questionnaire) and glycemic control (HbA1C).

The intervention group will receive the diabetes self management education package alongwith the routine care while the control group will receive the routine standard care.

Comparison of self care activities, self-care efficacy, quality of life and HbA1C measurements will be done at baseline and at 6 months in both the groups.

If the intervention proves useful, it may be extended to primary health centres and villages where health workers may be trained to provide structured education on diabetes self management.

 
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