Effect of self care interventions on diabetes self management practices & blood sugar control among type 2 diabetic patients a mixed method study protocol

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2023/12/060685
• Lead Sponsor: Sri Manakula Vinayagar Medical College and Hospital

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-12-21
• Study Start: 2023-12-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sri Manakula Vinayagar Medical College and Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri Manakula Vinayagar Medical College and Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr B Sowbarnika Vaishnavi

Principal investigator

9500746766

subavaishu9092@gmail.com