Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema

NCT ID: NCT05019807

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2021-12-21

Brief 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.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

WhatsApp group

The arm receives education information about diabetes and its complications, diet and physical activities through WhatsApp.

Group Type: OTHER

WhatsApp group

Intervention Type: OTHER

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.

Control group

The arm does not received any education information.

Group Type: OTHER

Control group

Intervention Type: OTHER

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.

Interventions

WhatsApp group

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.

Intervention Type: OTHER

Control group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than 50 years
• Diagnosed care of DME who had not underwent treatment elsewhere
• Received at least one laser treatment or pharmacotherapy
• Attended at least one follow-up clinical visit
• Patients willing to learn, listed to others and talk about themselves.
• Patients who have access to smart phone.

Exclusion Criteria

• Patients with ocular co-morbidities other than DME
• Patients refusing to abide by group guidelines and demonstrating serious problems with interpersonal relationships.
• Contrary to popular opinion, people who do poorly in groups.
• Difficult patients who are self-centered.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lions Club International Foundation

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Raman

Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Raman, MS,DNB, FRCS"Ed

Role: PRINCIPAL_INVESTIGATOR

Sankara Nethralaya

Locations

Rajiv Raman

Chennai, Tamil Nadu, India

Countries

India

Other Identifiers

864-2020-P

Identifier Type: -

Identifier Source: org_study_id