| CTRI Number |
CTRI/2024/06/068924 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of self-management education on glycemic control in Diabetes patients |
|
Scientific Title of Study
|
Effectiveness of self management education on glycemic control in patients of type 2 diabetes mellitus at Urban Health Training Centre of AIIMS Nagpur A Quasi-experimental mixed method study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priti Nandkishor Tiwari |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Nagpur |
| Address |
All India Institute of Medical Sciences, Nagpur
Plot no.2, Sector-20,Mihan, Nagpur– 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9146427819 |
| Fax |
|
| Email |
dtobnd21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Nandkishor Tiwari |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Nagpur. |
| Address |
All India Institute of Medical Sciences, Nagpur.
Plot no.2, Sector-20,Mihan, Nagpur– 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9146427819 |
| Fax |
|
| Email |
dtobnd21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti Nandkishor Tiwari |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Nagpur. |
| Address |
All India Institute of Medical Sciences, Nagpur.
Plot no.2, Sector-20,Mihan, Nagpur– 441108
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9146427819 |
| Fax |
|
| Email |
dtobnd21@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Nagpur.
Plot no.2, Sector-20,Mihan, Nagpur– 441108, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Priti Nandkishor Tiwari |
| Address |
All India Institute of Medical Sciences, Nagpur.
Plot no.2, Sector-20,Mihan, Nagpur– 441108 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Priti Tiwari |
All India Institute of Medical Sciences, Nagpur. |
Department of Community Medicine, OPD Division, Room number 1, Darshan Colony, Nandanvan
Nagpur
MAHARASHTRA |
9146427819
dtobnd21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Nagpur, 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 |
Health Education for Behavioral change |
The first session will be conducted at the time of registration, after baseline examination and
investigations. After this, sessions will be conducted once in 15 days for one month. These sessions will
be continued every month for six months. The cushion period of seven days (before or after their
respective dates) will be given in the follow-up due to public holidays and personal reasons of the study
participants. This will include total seven sessions, each session will require approximately 45 – 60
minutes. Follow up evaluation will be done at completion of three month and six month before health
education session of that day. After evaluation at six month, one extra session of Diabetes selfmanagement education will be given as part of good clinical practice. These sessions will be conducted
in local language. The content of self-management education sessions includes signs and symptoms of
diabetes, investigation needed for diagnosis and monitoring through blood sugar level. Pharmacological
and Non- pharmacological modalities of treatment like weight reduction among obese individual,
physical activity, dietary advice will be given for glycemic control and prevention of complications.
Emphasis on adherence to drug and regular physician contact will be explained. Counseling on any
addiction if found will be done and necessary medical help will be taken. All participants will be told to
attend diabetes self-management education session on a particular date and sessions will be conducted
accordingly. Personal counseling will be conducted to address individual specific problems related to
self-care practice and lifestyle. Session will focus on 1. Dietary modifications
2.Physical activity 3.stress management 4. Addiction |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are above the age of 30 years and are diagnosed case of Type 2 Diabetes mellitus will be included in study. |
|
| ExclusionCriteria |
| Details |
1)Those not willing to give consent
2)Pregnant women or planning to become pregnant in next one year
3)Severe mental illness
4)Those with complications of Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic control that is mean change in fasting and postmeal glucose level |
baseline, at 3 month and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in lipid profile
Barriers in following behavioral changes |
at six month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/08/2024 |
| 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="0"
Months="9"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dtobnd21@gmail.com].
- For how long will this data be available start date provided 01-12-2024 and end date provided 16-01-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NO
|
|
Brief Summary
|
Diabetes
Mellitus is a burning health problem worldwide. Diabetes is rapidly attaining
the status of a likely epidemic in India, with more than 62 million diabetic
people currently diagnosed with the
disease. . An essential component of diabetes management includes both
anti-diabetic drugs and lifestyle modification. Self-management education is an
important and cost effective tool in management of diabetes. Primary objective
of the study is to assess the effectiveness of self-management education
on glycemic control
in type-2 diabetes
mellitus patients. Study will be
conducted at Urban Health Training
Centre of AIIMS Nagpur. Approval from the
Institutional ethics committee will be sought before the start of the study.
The study will be registered in the clinical trial registry of India. Baseline
examination and investigations will be carried out and total seven sessions of
health education will be carried out. Examination
and investigations will be repeated at third and sixth month to assess the
outcome. The data will be compiled in Microsoft Excel and will be analyzed
using Epi Info 7.2
|