Diabetic Retinopathy
Conditions
Keywords
Diabetic retinopathy, Diabetes, Occupational Health, Screening, Retinophotography
Brief summary
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.
Detailed description
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.
Interventions
DEVICENon-mydriatic retinography
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.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Worker * Adult (≥18 years old) * Diabetic * Affiliated with a Social Security scheme * Able to give informed consent to participate in the research
Exclusion criteria
* Protected persons (minors, guardianship, curatorship, deprived of freedoms, safeguard of justice) * Pregnant or breastfeeding women; these women may be offered participation after pregnancy and/or breastfeeding * Non-voluntary person
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of diabetic retinopathy screening in an Occupational Health setting | Day 1 | Proportion of eligible workers who consent to undergo the proposed retinal screening during their Occupational Health visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of diabetic retinopathy detected by retinophotography in diabetic workers | Day 1 | Proportion of screened diabetic workers with diabetic retinopathy detected by retinophotography. |
| Type of diabetes | Day 1 | 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. |
| Year of diabetes diagnosis | Day 1 | Year of discovery of diabetes, assessed using the self-administered questionnaire. The measurement unit is calendar year. |
| Last HbA1c value | Day 1 | Last HbA1c value, assessed using the self-administered questionnaire. HbA1c is reported as a percentage (%). |
| Time since last HbA1c measurement | Day 1 | 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. |
| Diabetes complications | Day 1 | Presence of diabetes complications, assessed using the self-administered questionnaire. Diabetes complications are reported by participants in a free-text field. |
| Time since last ophthalmological assessment | Day 1 | Time since the participant's last ophthalmological assessment, assessed using the self-administered questionnaire and expressed in months. |
| Time since last cardiovascular assessment | Day 1 | Time since the participant's last cardiovascular assessment, assessed using the self-administered questionnaire and expressed in months. |
| Antidiabetic treatment | Day 1 | 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. |
| Age | Day 1 | Age assessed using the self-administered questionnaire and expressed in years. |
| Gender | Day 1 | Grnder assessed using the self-administered questionnaire. Categories are female and male. Results will be reported as the percentage (%) of participants in each category. |
| Body mass index | Day 1 | 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. |
| Family status | Day 1 | 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. |
| Number of children | Day 1 | 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. |
| Educational level | Day 1 | 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. |
| Daily tobacco consumption | Day 1 | 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. |
| Weekly alcohol consumption | Day 1 | 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. |
| Leisure-time physical activity | Day 1 | Duration of leisure-time physical activity assessed using the self-administered questionnaire and expressed in hours per week. |
| Occupational physical activity | Day 1 | Duration of physical activity at work assessed using the self-administered questionnaire and expressed in hours per week. |
| Total daily sitting time | Day 1 | Total sitting time assessed using the self-administered questionnaire and expressed in hours per day. |
| Daily sitting time at work | Day 1 | Sitting time at work assessed using the self-administered questionnaire and expressed in hours per day. |
| Occupational status | Day 1 | Current or last occupational status assessed using the self-administered questionnaire. Results will be reported as the percentage (%) of participants in each occupational category. |
| Sector of activity | Day 1 | 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. |
| Weekly working time | Day 1 | Number of hours worked per week assessed using the self-administered questionnaire and expressed in hours per week. |
| Daily working time | Day 1 | Number of hours worked per working day assessed using the self-administered questionnaire and expressed in hours per working day. |
| Percentage of working time spent sitting | Day 1 | Proportion of working time spent sitting assessed using the self-administered questionnaire and expressed as a percentage (%). |
| Night work | Day 1 | 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. |
| Number of weekends worked per month | Day 1 | 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. |
| Telework | Day 1 | Telework assessed using the self-administered questionnaire as yes or no. Results will be reported as the percentage (%) of participants reporting telework. |
| Percentage of working time performed as telework | Day 1 | 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%. |
| Job seniority | Day 1 | 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. |
| Employment contract | Day 1 | 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. |
| Work-related stress assessed using a Visual Analog Scale | Day 1 | Work-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Home-related stress assessed using a Visual Analog Scale | Day 1 | Home-related stress assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum) |
| Fatigue assessed using a Visual Analog Scale | Day 1 | Fatigue assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Sleep quality assessed using a Visual Analog Scale | Day 1 | Sleep quality assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent). |
| Anxiety assessed using a Visual Analog Scale | Day 1 | Anxiety assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Mood assessed using a Visual Analog Scale | Day 1 | Mood assessed using a Visual Analog Scale (VAS) ranging from 0 (poor) to 100 (excellent). |
| Burnout assessed using a Visual Analog Scale | Day 1 | Burnout assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Job control assessed using a Visual Analog Scale | Day 1 | Job control assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Job demand assessed using a Visual Analog Scale | Day 1 | Job demand assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Support from hierarchy assessed using a Visual Analog Scale | Day 1 | Support from hierarchy assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Support from colleagues assessed using a Visual Analog Scale | Day 1 | Support from colleagues assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
| Job satisfaction in relation to efforts assessed using a Visual Analog Scale | Day 1 | Job satisfaction in relation to efforts made at work assessed using a Visual Analog Scale (VAS) ranging from 0 (minimum) to 100 (maximum). |
Countries
France
Contacts
CONTACTLise Laclautre
PRINCIPAL_INVESTIGATORFrédéric Dutheil
University Hospital, Clermont-Ferrand
Outcome results
None listed