Diabetic retinopathy is a complication of diabetes that can affect vision. Early detection and appropriate management can help prevent or delay vision loss. However, some people with diabetes do not receive the recommended regular eye examinations. The RETINOMED study is a pilot study designed to evaluate the feasibility of offering diabetic retinopathy screening to workers with diabetes through an Occupational Health service. Participants will attend a single study visit at the Occupational Health Department of Clermont-Ferrand University Hospital. During this visit, retinal photographs will be taken using a non-mydriatic retinal camera, which does not require pupil dilation. Participants will also complete a questionnaire about their sociodemographic and occupational characteristics, lifestyle, and diabetes. The study will assess the acceptability of this screening program among eligible workers. It will also estimate the prevalence of diabetic retinopathy among screened workers and explore participant characteristics that may be associated with diabetic retinopathy.
RETINOMED is a monocentric, pilot exploratory study conducted at the Occupational Health Department of Clermont-Ferrand University Hospital, France. The study primarily aims to assess the feasibility of implementing diabetic retinopathy screening in an Occupational Health setting. Occupational Health services provide regular access to a large working population and may therefore offer an opportunity to improve access to diabetic retinopathy screening. Integrating such screening into Occupational Health could contribute to earlier detection of diabetic retinopathy and facilitate referral to appropriate ophthalmologic care when needed. Workers with diabetes may be informed about the study during an Occupational Health visit or through a screening campaign conducted by the Occupational Health Department. Workers who wish to participate will receive information about the study and will attend a single inclusion and screening visit. After informed consent, participants will undergo retinal photography using the FundusScope FC161 non-mydriatic retinal camera. The examination is non-invasive and does not require pupil dilation. Retinal images will subsequently be assessed by the Ophthalmology Department of Clermont-Ferrand University Hospital. Participants will also complete a self-administered questionnaire, electronically using REDCap or on paper when necessary. The questionnaire will collect information on diabetes, sociodemographic and occupational characteristics, lifestyle factors, and several self-reported measures related to health and work. Each participant will attend only one study visit, lasting approximately 30 minutes. Participants will be informed of their retinal screening results and, when necessary, will be referred to an appropriate care pathway. The primary focus of the study is the acceptability of diabetic retinopathy screening in the Occupational Health setting. The study will also estimate the prevalence of diabetic retinopathy detected through the screening program and describe the characteristics of participating workers, including factors potentially associated with diabetic retinopathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
400
Retinophotography will be performed using the non-mydriatic retinograph FundusScope FC161. The retinal images will subsequently be analyzed by the Ophthalmology Department. Screened workers will be informed of their results and will be redirected to the care pathway if necessary.
Participants will complete a self-administered questionnaire, administered online via REDCap® or in paper version for individuals who may have difficulty using computers. The questionnaire will collect information about diabetes, occupational characteristics, sociodemographic characteristics, visual analog scales of stress at work, stress at home, anxiety, sleep quality, fatigue, mood/morale, burnout, autonomy at work, workload, support from the hierarchy, support from colleagues and satisfaction at work in relation to efforts deployed, and lifestyle variables including sitting, physical activity, alcohol and tobacco.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
Acceptability of diabetic retinopathy screening in an Occupational Health setting
Proportion of eligible workers who consent to undergo the proposed retinal screening during their Occupational Health visit.
Time frame: Day 1
Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers
Proportion of screened diabetic workers with diabetic retinopathy detected by retinophotography.
Time frame: Day 1
Type of diabetes
Type of diabetes (type 1, type 2, or other), assessed using the self-administered questionnaire. Results will be reported as the percentage of participants in each category.
Time frame: Day 1
Year of diabetes diagnosis
Year of discovery of diabetes, assessed using the self-administered questionnaire. The measurement unit is calendar year.
Time frame: Day 1
Last HbA1c value
Last HbA1c value, assessed using the self-administered questionnaire. HbA1c is reported as a percentage (%).
Time frame: Day 1
Time since last HbA1c measurement
Time since the last HbA1c measurement assessed using the self-administered questionnaire. Categories are 1 month, 2 months, 3 months, 4 to 6 months, more than 6 months, and more than 1 year. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Diabetes complications
Presence of diabetes complications, assessed using the self-administered questionnaire. Diabetes complications are reported by participants in a free-text field.
Time frame: Day 1
Time since last ophthalmological assessment
Time since the participant's last ophthalmological assessment, assessed using the self-administered questionnaire and expressed in months.
Time frame: Day 1
Time since last cardiovascular assessment
Time since the participant's last cardiovascular assessment, assessed using the self-administered questionnaire and expressed in months.
Time frame: Day 1
Antidiabetic treatment
Antidiabetic treatment assessed using the self-administered questionnaire. Categories include insulin, oral antidiabetic treatment, physical activity, diet, and other treatment. Multiple responses are possible. Results will be reported as the percentage (%) of participants reporting each category.
Time frame: Day 1
Age
Age assessed using the self-administered questionnaire and expressed in years.
Time frame: Day 1
Gender
Grnder assessed using the self-administered questionnaire. Categories are female and male. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Body mass index
Body mass index calculated from self-reported height in centimeters and weight in kilograms collected using the questionnaire. Body mass index is expressed in kg/m².
Time frame: Day 1
Family status
Family status assessed using the self-administered questionnaire. Categories are living as a couple and single. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Number of children
Number of children assessed using the self-administered questionnaire. Categories are none, 1, 2, and 3 or more children. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Educational level
Educational level assessed using the self-administered questionnaire. Categories are " ≤ brevet des collèges , CAP/BEP , Bac , Bac+1/+4 , Bac+5 and \>Bac+5" Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Daily tobacco consumption
Number of cigarettes smoked per day assessed using the self-administered questionnaire. Categories are 0, 1-4, 5-9, 10-14, 15-19, and \>20 cigarettes per day. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Weekly alcohol consumption
Number of alcoholic drinks consumed per week assessed using the self-administered questionnaire. Categories are 0, 1-4, 5-9, 10-14, 15-19, and \>20 drinks per week. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Leisure-time physical activity
Duration of leisure-time physical activity assessed using the self-administered questionnaire and expressed in hours per week.
Time frame: Day 1
Occupational physical activity
Duration of physical activity at work assessed using the self-administered questionnaire and expressed in hours per week.
Time frame: Day 1
Total daily sitting time
Total sitting time assessed using the self-administered questionnaire and expressed in hours per day.
Time frame: Day 1
Daily sitting time at work
Sitting time at work assessed using the self-administered questionnaire and expressed in hours per day.
Time frame: Day 1
Occupational status
Current or last occupational status assessed using the self-administered questionnaire. Results will be reported as the percentage (%) of participants in each occupational category.
Time frame: Day 1
Sector of activity
Current or last sector of activity assessed using the self-administered questionnaire. Results will be reported as the percentage (%) of participants in each sector of activity.
Time frame: Day 1
Weekly working time
Number of hours worked per week assessed using the self-administered questionnaire and expressed in hours per week.
Time frame: Day 1
Daily working time
Number of hours worked per working day assessed using the self-administered questionnaire and expressed in hours per working day.
Time frame: Day 1
Percentage of working time spent sitting
Proportion of working time spent sitting assessed using the self-administered questionnaire and expressed as a percentage (%).
Time frame: Day 1
Night work
Night work assessed using the self-administered questionnaire. Categories are no night work, fixed night work, shift work, variable or occasional night work, and other. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Number of weekends worked per month
Number of weekends worked per month assessed using the self-administered questionnaire. Categories are 0, 1, 2, 3, and 4 or more weekends per month. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Telework
Telework assessed using the self-administered questionnaire as yes or no. Results will be reported as the percentage (%) of participants reporting telework.
Time frame: Day 1
Percentage of working time performed as telework
Percentage of working time performed as telework among participants reporting telework, assessed using the self-administered questionnaire. Categories are \<20%, 21-40%, 41-60%, 61-80%, and \>80%.
Time frame: Day 1
Job seniority
Seniority in the current position assessed using the self-administered questionnaire. Categories are \<6 months, 6 months to 1 year, 1-3 years, 3-5 years, 5-10 years, and \>10 years. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Employment contract
Employment contract assessed using the self-administered questionnaire. Categories are fixed-term contract, permanent contract or tenured position, work-study contract, temporary employment, and other. Results will be reported as the percentage (%) of participants in each category.
Time frame: Day 1
Work-related stress assessed using a Visual Analog Scale
Work-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Home-related stress assessed using a Visual Analog Scale
Home-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum)
Time frame: Day 1
Fatigue assessed using a Visual Analog Scale
Fatigue assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Sleep quality assessed using a Visual Analog Scale
Sleep quality assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent).
Time frame: Day 1
Anxiety assessed using a Visual Analog Scale
Anxiety assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Mood assessed using a Visual Analog Scale
Mood assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent).
Time frame: Day 1
Burnout assessed using a Visual Analog Scale
Burnout assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Job control assessed using a Visual Analog Scale
Job control assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Job demand assessed using a Visual Analog Scale
Job demand assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Support from hierarchy assessed using a Visual Analog Scale
Support from hierarchy assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Support from colleagues assessed using a Visual Analog Scale
Support from colleagues assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
Job satisfaction in relation to efforts assessed using a Visual Analog Scale
Job satisfaction in relation to efforts made at work assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum).
Time frame: Day 1
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