| CTRI Number |
CTRI/2023/11/060294 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effect of self management education in self-care activities of patients with Type 2 Diabetes |
|
Scientific Title of Study
|
Effectiveness of a Structured Diabetes Education Package among Patients with Type 2 Diabetes Attending an Urban Health Centre in East Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radhikaa Sharma |
| Designation |
PG Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Community Medicine,
Lady Hardinge Medical College, Delhi
Central
DELHI
110001
India |
| Phone |
8402074208 |
| Fax |
|
| Email |
radhikaasharma176@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anita Shankar Acharya |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Community Medicine,
Lady Hardinge Medical College, Delhi
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
anitaacharya29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Radhikaa Sharma |
| Designation |
PG Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Community Medicine,
Lady Hardinge Medical College, Delhi
Central
DELHI
110001
India |
| Phone |
8402074208 |
| Fax |
|
| Email |
radhikaasharma176@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Delhi |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College,
Shaheed Bhagat Singh Marg, Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Radhikaa Sharma |
Urban Health Centre, Kalyanpuri |
Block 18, Kalyanpuri
New Delhi 110091
East
DELHI |
8402074208
radhikaasharma176@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lady Hardinge Medical College |
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 |
A structured diabetes education package |
A diabetes self management education package was designed over a period of two months and will be delivered to the study participants. The package will be delivered to groups of 10 to 12 participants, in two 45-minute sessions, within a month of the enrolment of the participant. It will consist of a ten-minute video to facilitate behavioural change, a flipchart and a PowerPoint presentation to demonstrate the seven key areas of self-care behaviours, namely, healthy coping, healthy eating, being active, taking medication, monitoring, problem solving and reducing risks. Demonstration of important self-care behaviour, such as foot care, will be done, and participants will be encouraged to demonstrate the learned skills. Individually suitable diet plans and exercise schedules will also be imparted to the participants. The package will be imparted at baseline, 3 months and 6 months, with participants being followed up for a six-month duration. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type 2 diabetes under treatment at UHC Kalyanpuri for at least six months. |
|
| ExclusionCriteria |
| Details |
Pregnant women, Patients with Type 2 diabetes on insulin therapy, Patients with chronic complications which hinder self care activities (eg diabetic foot, advanced diabetic retinopathy, advanced diabetic nephropathy), Patients unable to communicate for any reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in diabetes self-care activities after administration of intervention among the study subjects at the end of the study. |
at baseline, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in clinical outcomes, viz, FBS, HbA1c, skin-fold thickness among the study subjects. |
at baseline, 3 months & 6 months. |
| Proportion of study subjects who perceive the education package as useful. |
at baseline, 3 months & 6 months. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
04/12/2023 |
| 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)
|
Not Yet Recruiting |
| 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
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [radhikaasharma176@gmail.com].
- For how long will this data be available start date provided 08-11-2023 and end date provided 08-10-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Diabetes Self-Management Education and Support (DSME/S) is an evidence-based, cost-effective package to facilitate informed self-management and decision-making for people with diabetes. There are significant gaps in people’s knowledge about diabetes, which can adversely affect motivation for treatment and self-care adherence. Improvement in self-care activities can reduce the chance of developing complications and early mortality. Access to locally adapted self-management education can change patients’ attitudes about their disease, medication and self-care activities. There is a dearth of studies on the effect of self-management education on diabetes management in India. This study is an attempt to find the effect of a diabetes self management education interventional package on the self care activities among patients with type 2 diabetes. This will help us understand the impact of such a low-cost intervention and understand the feasibility of its implementation in the longer term. |