Clinical trial NCT06604104: Visual Frailty in Ageing
Official title: Seeing Through Their Eyes - Towards Defining Visual Frailty in Ageing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Age-Related Macular Degeneration
Functional Status
Mental Health
Depression
Anxiety
Cognitive Impairment
Visual Impairment
Keywords: Visual frailty
Frailty
Ageing
Reading performance
Age-related Macular Degeneration (AMD)
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 60 and above with a known diagnosis of advanced Age-related Macular Degeneration (AMD) will be recruited from Princess Alexandra Eye Pavilion (PAEP) macular clinic.

Their relatives or carers will also participate in the study but their data will be collected remotely. The term relatives/carers will be restricted to spouses/partners or children of the patients with advanced AMD.

Brief summary: The goal of this observational study is to define visual frailty and refine monitoring for an ageing population. It involves piloting a visual frailty assessment tool in a cohort of patients aged 60 and above with a known diagnosis of Age-related Macular Degeneration (AMD) in Princess Alexandra Eye Pavilion (PAEP), Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD). The main questions it aims to answer are:

* What is visual frailty and how can it be assessed or predicted in the global ageing population using visual acuity, reading performance, functional status, mental health and systemic co-morbidities?
* What is the relationship between visual acuity, reading performance, ocular diagnosis, co-morbidities, mental health, and functional status?

Participants will have the following data collected from them from either Princess Alexandra Eye Pavilion, Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD):

* Visual acuity (both distance and near)
* Reading performance
* Functional status
* Mental health
* Co-morbidities

Data will also be collected remotely (by phone call) from both the participants and their carers/relatives about their perceptions of visual frailty.

Expert opinion will be sought from optometrists and ophthalmologists about the concept of visual frailty using an online survey.

Detailed description: This is a mixed methods observational cross-sectional study that will consist of designing a tool to measure visual frailty and piloting it in a cohort of participants in the ageing population. The study will be implemented over a period of three years: literature review to define visual frailty and designing of the tool in the first year, recruitment of participants and performing a pilot and a validation study in the second year and thesis write-up in the final year.

Participants aged 60 and above with a known diagnosis of advanced Age-related Macular Degeneration (AMD) will be recruited from Princess Alexandra Eye Pavilion (PAEP) macular clinic, Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD).

The visual frailty index will consist of results from visual acuity, reading performance, functional status, mental health and co-morbidities. This tool will be piloted in a cohort of 20 patients with advanced AMD. The internal consistency of the tool will be determined at this phase of the project.

In addition to visual frailty, physical frailty will also be assessed in this cohort to enable analysis and establishment of the relationship between the two.

The patients with AMD and their relatives/carers will be invited to participate in remote data collection about their perspectives on visual frailty.

Best corrected distance and near visual acuity will be assessed and recorded. Reading performance will consist of reading speed and reading acuity which will be automatically measured using Digital Radner that will be acquired and installed before the implementation of the study.

Functional status will be assessed using Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale.

Mental health will consist of depression, anxiety, and cognitive impairment that will be assessed using General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and Six-item Cognitive Impairment Test (6-CIT) respectively. All these are validated tools.

Physical frailty will be assessed using the FRAIL scale which relies on functions of fatigue, resistance, ambulation, illnesses and loss of weight.

Information about co-morbidities will be retrieved from the patients' health record through National Health Service (NHS) Lothian.

The data to be collected remotely from both the patients and their relatives/carers will be done through a phone call which will be scheduled during the hospital appointment. These calls will be recorded for analysis. They will then be transcribed verbatim, coded, and themes will be generated during the analysis.

In addition to defining and designing a tool to measure visual frailty, expert input will be sought from optometrists and ophthalmologists about this topic using an online survey.

Eligibility criteria: Inclusion Criteria:

* Participants should be residents of Scotland aged 60 years and above with a known diagnosis of advanced AMD.
* The patients should be receiving treatment from Princess Alexandra Eye Pavilion (PAEP) for at least 6 months and should be responding positively to the treatment. This is to rule out poor results due to either not receiving medication or non-compliance.
* The participants should be able to provide informed consent before taking part in the study.

Exclusion Criteria:

* Participants who cannot speak and read English language will not be included in this pilot study. However, non-English speakers will be included in the future together with interpreters at the validation phase of the developed tool.
* Participants who have undergone invasive ocular surgery like cataract extraction in their previous visit.
* The potential participants who fail to provide or do not provide informed consent will not be included in the study.

Primary outcomes:
measure: Visual frailty
timeFrame: Within the first day of enrollment into the study.
Secondary outcomes:
measure: Visual acuity
timeFrame: Within the first day of enrollment into the study.
measure: Reading performance
timeFrame: Within the first day of enrollment into the study.
measure: Functional status
timeFrame: Within the first day of enrollment into the study.
measure: Mental health (Depression)
timeFrame: Within the first day of enrollment into the study.
measure: Mental health (Anxiety)
timeFrame: Within the first day of enrollment into the study.
measure: Mental health (Cognitive Impairment)
timeFrame: Within the first day of enrollment into the study.
measure: Co-morbidities
timeFrame: Within the first day of enrollment into the study.
measure: Physical frailty
timeFrame: Within the first day of enrollment into the study.
measure: Correlation between visual frailty and physical frailty
timeFrame: This will be done immediately after assessment of both visual frailty and physical on the first day.
measure: Correlation between Age-related macular degeneration and frailty
timeFrame: This will be done immediately after assessment of physical frailty on the first day.
measure: Perception about visual frailty
timeFrame: Within 4 weeks from the assessment date of visual frailty.
measure: Expert opinion about visual frailty
timeFrame: From enrolment to the end of the study, an average of approximately 3 months.
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: The Princess Alexandra Eye Pavilion
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Anne Rowling Clinic
Study officials:
affiliation: Princess Alexandra Eye Pavilion
name: Peter Cackett
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Engineering, University of Edinburgh
name: Ian Underwood
role: STUDY_DIRECTOR
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