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Impact of group-based diabetes self-management education (DSME)package on self-care activities,diabetic control, and quality of life among diabetic patients.

Recruiting
Conditions
Type 2 diabetes mellitus without complications,
Registration Number
CTRI/2019/02/017589
Lead Sponsor
Hamdard Institute of Medical Sciences and Research
Brief Summary

Diabetes has increasingly become a major healthproblem worldwide. India hasn’t been far behind, having the secondhighest prevalence of diabetes, in advancing to 72·0 million prevalentcases of diabetes in 2017, as compared with 26·0 million in 1990. Thedevelopment of complications affects the quality of life in these individuals.Episodes of hypoglycaemia, fear of hypoglycaemia, change in life style and fearof long term consequences may lead to reduced health-related quality of life(HRQoL).  Diabetes mellitus is a chronic disease that can affect allaspects of life.

Diabetes self-management education (DSME) isrecognized as a fundamental component of diabetes care. and it is believedthat improving patient self-efficacy is a critical pathway to improvedself-management  The goal of DSME is to help patients acquire theknowledge, information, self-care practices, coping skills, and attitudesrequired for the effective self-management of their diabetes. Severalreviews and meta-analyses have found DSME interventions to have a positiveimpact on diabetes-related health and psychosocial outcomes, specificallyincreasing diabetes-related knowledge and improving blood glucose monitoring,dietary and exercise habits, foot care, medication taking, coping skills, andglycemic control.

The proposed study will be conducted in the health centresof the field practice areas under the Department of Community Medicine, HamdardInstitute of Medical Sciences and Research(HIMSR) and the Diabetic clinic,Department of  Medicine, HAHC Hospital,HIMSR.

The proposed study will be a Randomized controlledtrial. A total of 200 patients (diagnosed with type-2 diabetes mellitus will berandomized into two groups (100 patients each).

A baseline assessment of knowledge, self careactivities (by using SDSCA questionnaire) , Diabetes self-care efficacy( byusing Diabetes Management Self-Efficacy Scale (DMSES)), Qualityof life ( by using DMQoLquestionnaire)and glycemic control (HbA1C).

The intervention group will receive the diabetesself management education package alongwith the routine care while the controlgroup will receive the routine standard care.

Comparison of self care activities, self-careefficacy, quality of life and HbA1C measurements will be done at baseline andat 6 months in both the groups.

If the intervention proves useful, it may beextended to primary health centres and villages where health workers may betrained to provide structured education on diabetes self management.

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
All
Target Recruitment
200
Inclusion Criteria

Documented physician diagnosed type 2 diabetes for atleast 6 months Ability and willingness to provide informed consent (English or Hindi) No plans to move out of the area within the 12 month study period.

Exclusion Criteria

Patients of Type 1 Diabetes Patients of Gestational Diabetes Patients having severe complications – like retinopathy or stroke Any use of glucocorticoid therapy within the past 3 months Patients currently participating in a cardiac rehabilitation or formal weight loss programme.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glycemic Control andAt baseline and | 6 months
Diabetes Self Care ActivitiesAt baseline and | 6 months
Secondary Outcome Measures
NameTimeMethod
Cardiovascular risk factor assessmentAt baseline and
Diabetes self-efficacy
Quality of lifeAt baseline and

Trial Locations

Locations (2)

Field Study area

🇮🇳

South, DELHI, India

HAHC Hospital

🇮🇳

South, DELHI, India

Field Study area
🇮🇳South, DELHI, India
Dr Farishta Singh
Principal investigator
8377048314
farishtasingh@gmail.com

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