| CTRI Number |
CTRI/2023/12/060685 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of self care interventions on diabetes self management practices & blood sugar control among type 2 diabetic patients a mixed method study protocol |
|
Scientific Title of Study
|
Effect of self care interventions on diabetes self management practices & glycemic control among type 2 diabetic patients a mixed method study protocol |
| 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 B SOWBARNIKA VAISHNAVI |
| Designation |
post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Community Medicine
Sri Manakula vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605 107
India |
| Phone |
9500746766 |
| Fax |
|
| Email |
subavaishu9092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K PREMANANDH |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital -Pondicherry University |
| Address |
Department Of community Medicine
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9597948790 |
| Fax |
|
| Email |
preeem1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR B SOWBARNIKA VAISHNAVI |
| Designation |
Post graduate |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital -Pondicherry University |
| Address |
Department of Community Medicine
Sri Manakula Vinayagar Medical College and Hospital
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605 107
India |
| Phone |
9500746766 |
| Fax |
|
| Email |
subavaishu9092@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital
Madagadipet |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital
Madagadipet |
| Type of Sponsor |
Private 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 |
| Dr B Sowbarnika Vaishnavi |
Sri Manakula Vinayagar Medical College and Hospital |
Rural Health and Training Centre Thiruvennainallur
Department of Community Medicine
Sri Manakula Vinayagar Medical College and Hospital
Madagadipet
Pondicherry
PONDICHERRY |
9500746766
subavaishu9092@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Manakula Vinayagar Medical College and Hospital Pondicherry |
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 |
| Comparator Agent |
control group without intervention |
They do not receive any intervention like self care intervention on diabetic self practices like diet,physical exercise,healthy coping skills,risk reduction behaviour,medication adherence and problem solving skills |
| Intervention |
self care intervention |
diabetic self practices like diet,physical exercise,healthy coping skills,risk reduction behaviour,medication adherence and problem solving skills for a period of 1 year |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients who are known diabetics based on the medical records for the past 6 months whose HBA1C is more than 6.5 and less than 9 over the last 3 months under regular visit to NCD clinic at RHTC and on OHA without any complications and those who have mobile and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
diabetic patients with complications pregnant women HBA1C more than 8 those on insulin those who do not have mobile and those who do not give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in self care activities like increase in intake of fruits and vegetables increase in duration of physical activity increase in healthy coping skills increase in risk reduction behaviour increase in foot care |
At the end of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in glycated haemoglobin,fasting & post prandial levels & anthropometric measurements like Weight Waist circumference hip circumference & waist hip ratio |
At the end of 1 year |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/12/2023 |
| 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 - NO
|
|
Brief Summary
|
The study method is exploratory sequential study design using qualitative followed by quantitative method. The qualitative method will be used to identify the barriers and facilitators for self-care practices among people living with type 2 DM and also to provide the basis for the development of diabetes self-care intervention package. The quantitative or the intervention phase is used to implement the intervention package. Self-care interventions includes those on physical activity diet medication adherence good problem-solving skills healthy coping skills foot care and risk reduction behavior. |