Trial Outcomes & Findings for Integrating DR Into Mainstream Health System in Bangladesh (NCT NCT03658980)

Last Updated: 2024-02-16

Results Overview

Number of Participants Who Had Successful Referrals, resulting from a health education intervention (among non-compliant persons, i.e. those who do not avail appointment with an Eye Consultant at a tertiary hospital after being detected with probable Diabetic Retinopathy at a diabetes hospital) - to be measured using Pre and Post intervention questionnaire based on previously used questionnaires of similar published studies

Recruitment status

COMPLETED

Study phase

Target enrollment

299 participants

Primary outcome timeframe

5 months

Results posted on

2024-02-16

Participant Flow

Participant milestones

Participant milestones
Measure	Health Education Intervention Face-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90. Health Education Intervention: Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.	Control Group No Intervention will be conducted in this control group
Overall Study STARTED	143	156
Overall Study COMPLETED	139	151
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Education Intervention n=143 Participants Face-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90. Health Education Intervention: Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.	Control Group n=156 Participants No Intervention will be conducted in this control group	Total n=299 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 11.4 • n=143 Participants	51.0 years STANDARD_DEVIATION 10.8 • n=156 Participants	51.21 years STANDARD_DEVIATION 11.09 • n=299 Participants
Sex: Female, Male Female	72 Participants n=143 Participants	82 Participants n=156 Participants	154 Participants n=299 Participants
Sex: Female, Male Male	71 Participants n=143 Participants	74 Participants n=156 Participants	145 Participants n=299 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 5 months

Outcome measures

Outcome measures
Measure	Health Education Intervention n=143 Participants Face-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90. Health Education Intervention: Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.	Control Group n=156 Participants No Intervention will be conducted in this control group
Number of Participants Who Had Successful Referrals	92 Participants	44 Participants

SECONDARY outcome

Timeframe: 5 months

The secondary outcome 'Increase in knowledge about Diabetic Retinopathy' was measured using questionnaire. Data of participants of the two arms were analyzed during post intervention survey.

Outcome measures

Outcome measures
Measure	Health Education Intervention n=139 Participants Face-to-face health education session on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminders at Day 7, 30 and 90. Health Education Intervention: Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.	Control Group n=151 Participants No Intervention will be conducted in this control group
Increase in Knowledge About Diabetic Retinopathy Knows that long-term uncontrolled diabetes might be a cause for a vision problem known as DR	139 participants	59 participants
Increase in Knowledge About Diabetic Retinopathy Knows the symptoms of DR	139 participants	28 participants
Increase in Knowledge About Diabetic Retinopathy Knows that the onset of DR can be delayed	131 participants	21 participants
Increase in Knowledge About Diabetic Retinopathy Knows that DR can be treated	136 participants	136 participants
Increase in Knowledge About Diabetic Retinopathy Correctly indicated one of the symptoms of DR	134 participants	50 participants
Increase in Knowledge About Diabetic Retinopathy Correctly indicated one of the treatment option for DR	131 participants	35 participants
Increase in Knowledge About Diabetic Retinopathy Understands impact of non-compliance on vision	136 participants	129 participants
Increase in Knowledge About Diabetic Retinopathy Knows that a trained Eye Consultant at tertiary hospital provides eye care services	139 participants	68 participants
Increase in Knowledge About Diabetic Retinopathy Knows the days and times when Eye Consultant at tertiary hospital provides eye care services	133 participants	30 participants

Adverse Events

Health Education Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zara Khair

Hiroshima University

Phone: +8801715342168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place