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

NCT ID: NCT06058637

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2025-11-03

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 220 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.

Conditions

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Eye Diseases

Keywords

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Eye screening Elderly Home healthcare Visual impairment Cluster randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
Research assistants who will perform the measurements after randomisation will be masked.

Study Groups

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Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Eye screening on top of care

Group Type EXPERIMENTAL

Eye screening

Intervention Type DEVICE

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.

Interventions

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Eye screening

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.

Intervention Type DEVICE

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Easee B.V.

UNKNOWN

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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R.M.A. (Ruth) van Nispen

Prof.dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ruth van Nispen

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC - VUmc

Locations

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Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Rooth V, van der Aa H, Wisse RPL, Maarsingh OR, Koopmanschap M, Keunen JEE, Vermeulen H, Klaver CCW, Janssen G, van Rens GHMB, van Nispen RMA. Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial. Trials. 2024 Feb 2;25(1):102. doi: 10.1186/s13063-023-07882-0.

Reference Type DERIVED
PMID: 38308377 (View on PubMed)

Other Identifiers

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NL78386.029.21

Identifier Type: -

Identifier Source: org_study_id