Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604104
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Visual Frailty in Ageing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Seeing Through Their Eyes - Towards Defining Visual Frailty in Ageing
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VFiA
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 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 in Princess Alexandra Eye Pavilion
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 carersrelatives 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
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 in Princess Alexandra Eye Pavilion
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 carersrelatives 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
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 at The Princess Alexandra Eye Pavilion 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 relativescarers 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 relativescarers 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
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
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 at The Princess Alexandra Eye Pavilion 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 relativescarers 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 relativescarers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None