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

Primary Purpose

Eye Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Eye screening
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Eye Diseases focused on measuring Eye screening, Elderly, Home healthcare, Visual impairment, Cluster randomized controlled trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Amsterdam UMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care as usual

Eye screening on top of care

Arm Description

Outcomes

Primary Outcome Measures

Colenbrander-1M visual acuity
Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart

Secondary Outcome Measures

Colenbrander-1M visual acuity change
Average visual acuity change per eye in letters
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
Optometric status
Optometric status assessed by slitlamp/fundusfotography
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).
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.
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.
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).
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.
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.
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.

Full Information

First Posted
July 3, 2023
Last Updated
September 21, 2023
Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Easee B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT06058637
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Easee B.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
Keywords
Eye screening, Elderly, Home healthcare, Visual impairment, Cluster randomized controlled trial

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Research assistants who will perform the measurements after randomisation will be masked.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
No Intervention
Arm Title
Eye screening on top of care
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Eye screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colenbrander-1M visual acuity
Description
Incidence in clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity chart
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Colenbrander-1M visual acuity change
Description
Average visual acuity change per eye in letters
Time Frame
12 months
Title
Colenbrander-1M visual acuity change in participants with baseline visual impairment
Description
Number of participants with baseline visual impairment and clinically relevant change of 2 lines or more on the Colenbrander-1M visual acuity
Time Frame
12 months
Title
Optometric status
Description
Optometric status assessed by slitlamp/fundusfotography
Time Frame
12 months
Title
Vision related quality of life with the EyeQ questionnaire
Description
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).
Time Frame
12 months
Title
Amsler grid chart
Description
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.
Time Frame
12 months
Title
Fall and fracture calendar
Description
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.
Time Frame
12 months
Title
Depressive symptomatology measured with the PHQ-9 questionnaire
Description
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).
Time Frame
12 months
Title
Health related quality of life with the EuroQol 5-Dimension 5-Level questionnaire
Description
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.
Time Frame
12 months
Title
Wellbeing with the ICEpop CAPability questionnaire
Description
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.
Time Frame
12 months
Title
Health literacy with the European Health Literacy Survey Questionnaire
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Health care utilization with the Medical Cost Questionnaire
Description
The iMCQ is an instrument for measuring medical consumption. The iMCQ includes 35 questions on how often patients have contact with health care providers over the last 3 months.
Time Frame
12 months
Title
Process evaluation: questionnaire based on both the RE-AIM framework and Telemonitoring Acceptance Framework
Description
For the intervention group, a process evaluation will take place by using a questionnaire with 22 questions, which is developed based on both the RE-AIM framework and Telemonitoring Acceptance Framework. Three essential features of understanding the process through which outcomes are achieved will be identified: 1) context, 2) implementation and 3) mechanisms of impact. In addition, elements from the Telemonitoring Acceptance Framework will be used to assess trust, behavioral intention, self-efficacy, performance expectancy, effort expectancy, social influence, facilitating conditions, technology anxiety, hedonic motivation and user opinions regarding the nurse-assisted online eye-screening tool.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Rooth
Phone
0031204445037
Email
v.rooth@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth van Nispen
Organizational Affiliation
Amsterdam UMC - VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Rooth
Phone
0031204445037
Email
v.rooth@amsterdamumc.nl

12. IPD Sharing Statement

Learn more about this trial

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

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