Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema
To Compare the Compliance, Knowledge/Awareness About Diabetes, Physical Activity, Diet Plan and Attendance in Patients With Diabetic Macular Edema
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2021
CompletedFirst Submitted
Initial submission to the registry
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedApril 6, 2022
April 1, 2022
4 months
August 6, 2021
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Follow-up rate in patients with diabetic macular edema receiving education materials about diabetes and its complications.
To investigate the compliance of diabetes management in patients diagnosed with diabetic macular edema after providing educational materials in WhatsApp and compare with control group in a tertiary eye care institute in South India.
12 months
Study Arms (2)
WhatsApp group
OTHERThe arm receives education information about diabetes and its complications, diet and physical activities through WhatsApp.
Control group
OTHERThe arm does not received any education information.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rajiv Raman
Chennai, Tamil Nadu, 600006, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rajiv Raman, MS,DNB, FRCS"Ed
Sankara Nethralaya
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ophthalmologist
Study Record Dates
First Submitted
August 6, 2021
First Posted
August 25, 2021
Study Start
December 18, 2020
Primary Completion
April 21, 2021
Study Completion
December 21, 2021
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share
The datasets generated during and/or analyzed during the study are not publicly available, as it against the organization hospital policy. But are available from the corresponding author on reasonable request.