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
|
|
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
|
|
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. |