| CTRI Number |
CTRI/2025/01/079204 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Exploring the effects of self-care education module on managing diabetes a community-based study in Puducherry |
|
Scientific Title of Study
|
Impact of a comprehensive self care education module on diabetes management: a community based cluster randomized cross over trial in Puducherry |
| 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 J VARSHA |
| Designation |
Post graduate resident |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of community medicine Pondy Cuddalore Main Road, Kirumam Pakkam, Bahour Commune Panchayat, Bahour, Puducherry 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9489005494 |
| Fax |
|
| Email |
varsha.jothithirumal@avmc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.J.Arun daniel |
| Designation |
Professor, department of community medicine |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of community medicine Pondy Cuddalore Main Road, Kirumam Pakkam, Bahour Commune Panchayat, Bahour, Puducherry 607402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
arundaniel.jayakumar@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR J VARSHA |
| Designation |
Post graduate resident |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of community medicine Pondy Cuddalore Main Road, Kirumam Pakkam, Bahour Commune Panchayat, Bahour, Puducherry 607402
Pondicherry
PONDICHERRY
607002
India |
| Phone |
9489005494 |
| Fax |
|
| Email |
varshajothithirumal@avmc.edu.in |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital, Pondicherry 607402, India |
|
|
Primary Sponsor
|
| Name |
DrJVarsha |
| Address |
Junior resident, 1st YEAR POSTGRADUATE, Aarupadai veedu medical college |
| Type of Sponsor |
Research institution and hospital |
|
|
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 J Varsha |
Aarupadai Veedu Medical College |
Pondy Cuddalore Main Road, Kirumam Pakkam, Bahour Commune Panchayat, Bahour, Puducherry 607402
Pondicherry
PONDICHERRY |
9489005494
varsha.jothithirumal@avmc.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Human ethics committee ECR/847/inst/PY/2016/RR-20 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E088||Diabetes mellitus due to underlying condition with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
health education with a diabetic self care education module |
The self care module will be prepared with the inputs from the focus group discussion conducted at the beginning of the research
duration : 3 months |
| Comparator Agent |
people who do not receive the health education with self-care module |
But at the end of the study even this group will receive the intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Duration of disease: Six months and more
2. Treatment: On Oral hypoglycemic drugs or on insulin
3. Age: 18 years and above
|
|
| ExclusionCriteria |
| Details |
1. Bedridden patients
2. Gestational diabetes
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in mean hba1c levels after self care intervention |
Baseline - 3months-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| . The self care module developed at the end of FGD can be used to educate diabetic patients even after the study. |
At the baseline, after 3 months & after 6 months |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
03/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Title: Impact of a comprehensive self care education module on diabetes management : A community based cluster randomized cross over trial in Puducherry Primary objective: To assess the effect of a structured self care education module on the glycemic control among diabetic patients at rural and urban field Secondary objective: 1.To estimate the level of self care practices among diabetic patients at urban and rural field practice area 2.To explore the barriers and facilitators in adhering to good diabetic self care practices among the diabetics. Methodology of the research work: Setting: Rural and Urban field practice areas of AVMCH Study design: community based, cluster randomized controlled trial – (stepped wedge design) single arm cross over model Study participants: Diabetics attending to the rural and urban field practice areas of AVMC&H, Puducherry. Study duration: 2023-2025 |