Diabetic Macular EdemaNCT05019807
Comparing the Compliance to Follow-up in Patients With Diabetic Macular Edema
A study testing WhatsApp group in people with Diabetic Macular Edema, run by Lions Club International Foundation at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- WhatsApp group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 18 Dec 2020to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Compliance, Knowledge/Awareness About Diabetes, Physical Activity, Diet Plan and Attendance in Patients With Diabetic Macular Edema
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.
Read the 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
- Being tested
- WhatsApp group, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| WhatsApp group | Other | The arm receives education information about diabetes and its complications, diet and physical activities through WhatsApp. Receives: Other: WhatsApp group |
| Control group | Other | The arm does not received any education information. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start18 Dec 2020
- Primary completion21 Apr 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lions Club International Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Raman, Lions Club International Foundation
- Investigators
- Rajiv Raman, MS,DNB, FRCS"Ed, Principal investigator, Sankara Nethralaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019807
- Sponsor's protocol ID
- 864-2020-P
- Status last verified
- Apr 2022
- First submitted
- 6 Aug 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Compliance, Knowledge/Awareness About Diabetes, Physical Activity, Diet Plan and Attendance in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05019807
- Acronym / sponsor ID
- 864-2020-P
- Conditions
- Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lions Club International FoundationUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WhatsApp group | Other | Other: WhatsApp groupThe arm receives education information about diabetes and its complications, diet and physical activities through WhatsApp. |
| Control group | Other | Other: Control groupThe arm does not received any education information. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhatsApp groupPatients 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. | Other | WhatsApp group |
| Control groupPatient 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. | Other | Control group |
Primary outcome
Follow-up rate in patients with diabetic macular edema receiving education materials about diabetes and its complications.
Time frame: 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Raman, MS,DNB, FRCS"Ed principal investigator
Sankara Nethralaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp group in people with Diabetic Macular Edema, run by Lions Club International Foundation at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow-up rate in patients with diabetic macular edema receiving education materials about diabetes and its complications. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.