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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
WhatsApp group
Control group
Sponsored by
Lions Club International Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Macular Edema

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rajiv Raman

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

WhatsApp group

Control group

Arm Description

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

The arm does not received any education information.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2021
Last Updated
April 5, 2022
Sponsor
Lions Club International Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05019807
Brief Title
Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema
Official Title
To Compare the Compliance, Knowledge/Awareness About Diabetes, Physical Activity, Diet Plan and Attendance in Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2020 (Actual)
Primary Completion Date
April 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lions Club International Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WhatsApp group
Arm Type
Other
Arm Description
The arm receives education information about diabetes and its complications, diet and physical activities through WhatsApp.
Arm Title
Control group
Arm Type
Other
Arm Description
The arm does not received any education information.
Intervention Type
Other
Intervention Name(s)
WhatsApp group
Intervention Description
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
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Follow-up rate in patients with diabetic macular edema receiving education materials about diabetes and its complications.
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Raman, MS,DNB, FRCS"Ed
Organizational Affiliation
Sankara Nethralaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajiv Raman
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600006
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

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

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