Clinical trial NCT06058637: ISCREEN-study: Online Nurse-assisted Eye-screening in Home Healthcare
Official title: Online Nurse-assisted Eye-screening in Home Healthcare; Implementation Study and Economic Evaluation, from an Individual, Healthcare and Socio-political Perspective
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eye Diseases
Keywords: Eye screening
Elderly
Home healthcare
Visual impairment
Cluster randomized controlled trial
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Easee B.V.
First posted: 2023-09-28
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Colenbrander-1M visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Colenbrander-1M visual acuity change
timeFrame: 12 months
measure: Colenbrander-1M visual acuity change in participants with baseline visual impairment
timeFrame: 12 months
measure: Optometric status
timeFrame: 12 months
measure: Vision related quality of life with the EyeQ questionnaire
timeFrame: 12 months
measure: Amsler grid chart
timeFrame: 12 months
measure: Fall and fracture calendar
timeFrame: 12 months
measure: Depressive symptomatology measured with the PHQ-9 questionnaire
timeFrame: 12 months
measure: Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire
timeFrame: 12 months
measure: Wellbeing with the ICEpop CAPability questionnaire
timeFrame: 12 months
measure: Health literacy with the European Health Literacy Survey Questionnaire
timeFrame: 12 months
Other outcomes:
measure: Health care utilization with the Medical Cost Questionnaire
timeFrame: 12 months
measure: Process evaluation: questionnaire based on both the RE-AIM framework and Telemonitoring Acceptance Framework
timeFrame: 6 months
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Amsterdam UMC - VUmc
name: Ruth van Nispen
role: PRINCIPAL_INVESTIGATOR
References: