iSCREEN-study: Online Nurse-assisted Eye-screening in Home Healthcare

Study Overview
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Brief Summary
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The aim of this study is to investigate the cost-effectiveness of a nurse-assisted online eye-screening in home healthcare in reducing eye complaints.

Detailed Description
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Background: In the Netherlands, the prevalence of blindness and low vision is highest among the elderly in care institutions and in home healthcare (20-25%). A recent cross-sectional pilot study with one of the largest home healthcare organizations in the Netherlands (i.e. 'Buurtzorg Nederland') showed that simple eye-screening by community nurses helps to detect eye complaints among elderly people living independently. Of all patients who were referred to a general practitioner (GP), optician, optometrist or ophthalmologist based on this screening (20% of the total group), it was found that almost half had severe visual impairment, whereas others had eye complaints that had affected acuity to a smaller extent. In most cases, eye complaints could be treated with spectacles or cataract surgery, but also untreatable eye diseases were found. These complaints may not have been detected without eye-screening and treatment would not have been offered. Often, the elderly themselves or family/friends or care providers, do not recognize that their eyesight has decreased. However, this can negatively affect their quality of life and health status. To increase access to eye care the investigators will perform a study using an online eye screening, which can be performed by the community nurses or possibly the participants themselves in their home environment. Purpose: The aim of this study is to investigate the cost-effectiveness of a nurse-assisted online eye-screening in home healthcare in reducing eye complaints. Method: The investigators will perform a cluster-RCT to compare online eye-screening guided by community nurses in addition to care as usual to a control condition, receiving only care as usual. It will be performed in collaboration with several home healthcare organizations. Measurements in both groups will take place at baseline, after 6 months and 12 months. This will include visual acuity measurements, questionnaires and an optometric examination. This study will be conducted among 240 participants. Elderly clients, 65+, who receive home healthcare will be invited to participate. Clients who have a serious health condition, clients who are cognitively unable to participate, or clients who had received an optometric consultation within the last 6 months, will be excluded. The eye-screening is developed by Easee and is CE marked. During the test, the visual acuity will be measured both near and at distance, and the Amsler grid test will be performed. The results of the eye-screening will be checked by an optometrist, and will be made available to the participant. This will be done by letter including a recommendation for a referral, if necessary.

Official Title
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Online Nurse-assisted Eye-screening in Home Healthcare; Implementation Study and Economic Evaluation, From an Individual, Healthcare and Socio-political Perspective

Conditions
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Eye Diseases

Intervention / Treatment
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* Device: Eye screening


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients receive home healthcare for health problems 65 years or older Understanding of the Dutch language Cognitive ability to participate in research (six-item Mini Mental State Examination: score >3) Exclusion criteria Very serious health condition of the patient (i.e. terminal illness, receiving palliative home care) Cognitively unable to participate in research (e.g. late stage Alzheimer's/Dementia, Parkinson's) (six-item Mini Mental State Examination: score ≤3) Having received an optometric or ophthalmic consultation within the last 6 months

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Care as usual<br> | |
| Experimental: Eye screening on top of care<br> | Device: Eye screening<br>* Nurse-assisted eye-screening will take place with the Easee app, which is implemented on the tablet or laptop of the community nurse. The nurse's smartphone will function as a remote control by which he/she submits input to a computer screen that displays the test. If the participant can do the test by him or herself, the nurse will merely supervise to ensure correct application. Standard audio instructions guide the nurse and participant through the test. The test will start with triage questions, which are used to set up a correct referral. During the test, both eyes are tested consecutively, covering one eye at a time. The participant will wear his/her spectacles, if present. The participant is presented a sequence of optotypes (i.e. tumbling-E and triangle-circle optotypes) that the participant must correctly identify, in addition to various grate sizes, both near and at a distance. The Amsler grid test is performed to detect any macular problems.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colenbrander-1M visual acuity | Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colenbrander-1M visual acuity change | Average visual acuity change per eye in letters | 12 months | 
| Colenbrander-1M visual acuity change in participants with baseline visual impairment | Number of participants with baseline visual impairment and clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity | 12 months | 
| Optometric status | Optometric status assessed by slitlamp/fundusfotography | 12 months | 
| Vision related quality of life with the EyeQ questionnaire | EyeQ questionnaire with 46 items. The items can be scored from never to always. EyeQ scores are expressed on a theta logit-scale from -4 (highest vision related quality of life) to +4 (lowest vision related quality of life). | 12 months | 
| Amsler grid chart | The Amsler grid is a simple square containing a grid pattern and a dot in the middle. It is used to detect symptoms of macular degeneration. The chart is held at a distance of 30 cm. Single eye test will be done. A participant is asked to look at the central dot of the Amsler grid chart. In normal cases, the lines of the chart will be seen straight and parallel. 4 questions will be used to notice abnormalities such as distortion of lines, broken lines, missing lines and wavy lines. | 12 months | 
| Fall and fracture calendar | Falling accidents and bone fractures will be assessed with a shortened version of the 'fall and fracture calendar'. A questionnaire with 6 questions on the number of falls and fractures during the last 6 months. | 12 months | 
| Depressive symptomatology measured with the PHQ-9 questionnaire | 9 questions corresponding to the Diagnostic Statistical Manual symptoms for major depressive disorder during the past 2 weeks. The PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day). | 12 months | 
| Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire | EQ-5D-5L: covers the dimensions mobility, self-care, daily activities, pain and discomfort, and anxiety and depression. It contains a five response level: no problems to not able to. Scores will be converted to a single utility index score using the value set of the Netherlands to obtain scores on a formative scale from 0 (lowest quality of life) to 1 (highest quality of life). The visual analog scale (VAS) is included for marking overall health today. | 12 months | 
| Wellbeing with the ICEpop CAPability questionnaire | ICECAP-O: it measures five capability dimensions: attachment, security, role, enjoyment, and control. With one question per dimension. Each dimension can be scored on four levels. An overall score can range from 0 to 1, with higher scores indicating better capability. | 12 months | 
| Health literacy with the European Health Literacy Survey Questionnaire | HLS-EU-Q: 16 items, they can be scored from very easy to very difficult. Scoring varies between 0 and 16. Higher scores meaning more difficulty. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye screening, Elderly, Home healthcare, Visual impairment, Cluster randomized controlled trial