Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional

Summary: 
      Diabetic retinopathy (DR) is the microvascular complication in the eye due to uncontrolled
      diabetes. According to the International Diabetes Federation (IDF), 382 million people had
      diabetes in 2013 and this number is expected to rise to 592 million by 2035, while 175
      million people remain undiagnosed. Ninety percent of these people suffer from type 2 Diabetes
      mellitus(DM). Over time, patients with non-proliferative DR may progress to more advance
      stages of DR, with increased risk of vision threatening conditions such as diabetic macular
      edema (DME). DME is the most frequent cause of vision loss in patients with diabetes and
      eventually can lead to blindness. The management strategy is crucial to prevent or limit the
      progression of DR. Patient education creates an important tool to control diabetes, to
      prevent complications and to reduce the cost. Several studies point out that diabetes group
      education, compared with individual education, was equally effective at improving diabetes
      control. Another group based education for type 2 DM shown effective in improving HbA1c,
      knowledge of diabetes, reduction of systolic blood pressure, body weight and requirement for
      diabetes medication. Studies have showed that group education had significant changes
      compared with individual education in HbA1c in 6 and 12, months and significant changes were
      found in fasting blood glucose in 12 months, diabetes knowledge, and self-management skills.
      Moreover, a study supported that, compared with individual counselling, group self-management
      education was associated with fewer acute complications and some improvements in the care
      process. There is no adequate evidence of which educations methods are the most effective in
      improving clinical outcomes of people with type 2 diabetes. There was a lack in diabetes
      management in India regarding the multidisciplinary diabetic intervention tool.

      Thus the investigator's aim is to focus on interventions to improve the compliance,
      knowledge/awareness about diabetes, physical activity, diet plan and attendance for diabetic
      check-up which got emerged from a qualitative study. There is a need to monitor the diabetic
      patients closely to ensure the compliance towards intervention given at home.
    

Detailed description: 
      This is a single centre hospital based randomized interventional study. Patients meeting the
      inclusion criteria will be recruited by researcher, from retina clinic through
      ophthalmologist who are specialized in diabetic eye examination. The study participants
      chosen randomly will be given awareness or education by digital tool through smart phone in
      the intervention group and other half will receive the normal care (non-intervention group).
      All patients will take their prescribed diabetes medicines as per advised by the
      diabetologist/physician.
    

Intervention name(s): WhatsApp group; Control group
Intervention type(s): Other; Other
Intervention description(s): Patients under intervention group will attend an education sessions by structured videos and images with the help of digital tool-WhatsApp group chat administered by the researcher. The group will have the objective interaction with patients and researchers to convey about their view of opinion on sight threatening diabetic retinopathy and management. The structured programme included definition of diabetes mellitus, symptoms, risk factors, awareness of DM and DR, importance of self-care about the disease (eye care and blood glucose monitoring), dietary management and importance of physical activity (Life style modification). The groups will be tracked frequently by WhatsApp/telephonic call and will be documented. Confidentiality of all participants will be maintained.; Patient under non-intervention group will not attend or take part in the education sessions or interaction with other patients. Will receive only the general instructions or advises from ophthalmologists about management and follow-up visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research