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Trial registered on ANZCTR


Registration number
ACTRN12621001021864
Ethics application status
Approved
Date submitted
8/12/2020
Date registered
4/08/2021
Date last updated
20/07/2022
Date data sharing statement initially provided
4/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Engagement in Daily Activities by Older Adults with Visual Loss in Singapore
Scientific title
Characterising Activities, Participation and Goals of Older adults with Different Patterns of Visual Loss in Singapore
Secondary ID [1] 302318 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Low vision
319081 0
Visual field defect due to cortical event 321994 0
Condition category
Condition code
Eye 317029 317029 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a cross-sectional observational study that involves conducting observational and self-reported assessments related to the activities, participation and goals of a sample of participants recruited from the Tan Tock Seng Hospital (TTSH)’s low vision clinics.

The questionnaires and clinical assessments that will be completed by participants are:
1) Abbreviated Mental Test
2) Bells Test
3) Short Physical Performance Battery
4) Box and Block Test
5) Visual acuity screening with Low vision LeaNumbers Chart
6) Visual field screening with kinetic two-person confrontation test and California Central Field test
7) Impact of Visual Impairment Questionnaire
8) Activity Card Sort - Singapore
9 ) Canadian Occupational Performance Measure for self-selected activities
10) Canadian Occupational Performance Measure approach for performance of 7 standardized activities
11) Performance Quality Rating Scale approach for performance of 7 standardized activities

These assessments will be done at a single time point (baseline) across 2 face-to-face sessions at Tan Tock Seng Hospital's Occupational Therapy outpatient clinic, which have a total duration of 150 minutes for each participant. Session 2 will occur within two weeks of session 1. The assessments and interviews will be conducted by one of the investigators, who is an Occupational Therapist. The broad aim is to understand the difficulties in activities and participation restriction experienced by older adults with different patterns of visual loss and their self-identified goals.

Intervention code [1] 318607 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325187 0
Observer-rated performance in seven standardized daily activities measured using the Performance Quality Rating Scale (PQRS) (Martini et al., 2014).

This is a composite primary outcome assessing all 7 daily activities.

The 7 daily activities are:
1) Taking medication
2) Dialing numbers on a handphone
3) Making a cup of coffee
4) Inserting key into a keyhole to open a lock for a home
5) Reading newspaper
6) Walking to the coffeeshop
7) Buying food

Martini, R., Rios, J., Polatajko, H., Wolf, T., & McEwen, S. (2014). The performance quality rating (PQRS): reliability, convergent validity, and internal responsiveness for two scoring systems. Disability and Rehabilitation, 37(3), 231-238. doi: 10.3109/09638288.2014.913702
Timepoint [1] 325187 0
Baseline (2nd session)
Secondary outcome [1] 387123 0
Self-rated performance in seven standardized daily activities measured using the Canadian Occupational Performance Measure (COPM) (Law et al., 2014).

This is a composite secondary outcome assessing all 7 daily activities.

The 7 daily activities are:
1) Taking medication
2) Dialing numbers on a handphone
3) Making a cup of coffee
4) Inserting key into a keyhole to open a lock for a home
5) Reading newspaper
6) Walking to the coffeeshop
7) Buying food

Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H. J., & Pollock, N. (2014). Canadian occupational performance measure. Ottawa, Ontario: CAOT Publications ACE.
Timepoint [1] 387123 0
Baseline (2nd session)
Secondary outcome [2] 387124 0
Self-rated participation in occupations measured using the Activity Card Sort (ACS)-Singapore (Lim et al., 2018).

These include self-rated participation in occupations such as shopping in a store, household maintenance, laundry, sewing, cooking, photography, running, swimming, bowling, visiting with friends, volunteer work and travelling measured using the Activity Card Sort (ACS) - Singapore.

Lim, H. B.,Tan, H. L., Hobman, J., & Cheng, M. I. I. (2018). Activity Card Sort-Singapore. Singapore: Nanyang Polytechnic, School of Health Sciences.
Timepoint [2] 387124 0
Baseline (1st session)
Secondary outcome [3] 387125 0
Self-rated performance on self-selected activities measured using the Canadian Occupational Performance Measure (COPM) (Law et al., 2014).

These include self-rated participation in occupations such as personal grooming, community management, household management, paid work, leisure activities and socialization measured using the Canadian Occupational Performance Measure (COPM).

Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H. J., & Pollock, N. (2014). Canadian occupational performance measure. Ottawa, Ontario: CAOT Publications ACE.
Timepoint [3] 387125 0
Baseline (1st session)

Eligibility
Key inclusion criteria
-Age 65 years old and above
-Able to converse in English, Chinese or Malay
-Fulfill World Health Organisation’s criteria for low vision of:
Visual acuity 6/18 or less in the better eye, Or
Visual field defect of 10 degrees or less in the better eye Or
-Any visual field defects due to a cortical event.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Any cognitive impairment, as identified from the case history and participants who do not meet the cut off scores for the Abbreviated Mental Test (Sahadevan et al., 2000).
-Severe physical impairment, as identified from case history such as being bed or wheelchair bound.
-Visual neglect, as identified through the Bells Test (Gauthier et al., 1989).
-Total blindness (defined as nil perception of light) in both eyes, as identified from the case history.

Sahadevan, S., Lim, P. P., Tan, N. J., & Chan, S. P. (2000). Diagnostic performance of two mental status tests in the older Chinese: Influence of education and age on cut-off values. International Journal of Geriatric Psychiatry, 15(3), 234-241.

Gauthier, L., Dehaut, F., & Joanette, Y. (1989). The Bells Test: a quantitative and qualitative test for visual neglect. International Journal of Clinical Neuropsychology, 11(2), 49–54.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
To answer the primary hypothesis, which has one categorical independent variable (pattern of visual loss), and one dependent variable (PQRS score, a ranked discrete data scale), the Kruskal Wallis test of ranks is selected to test for evidence of the differences among the four patterns of visual loss. Likewise, for the secondary hypothesis, the Kruskal Wallis test will be conducted separately to test for evidence of the differences in COPM scores among the four patterns of visual loss, as the COPM scores are also ranked, discrete data. A set of planned comparisons, using the pairwise Wilcoxon signed rank test for each pair of groups, with Bonferroni adjustment, will be conducted to analyse which groups are different for the PQRS outcome. A similar set of planned comparison will be conducted for the COPM outcome. The PQRS and COPM scores will be presented using spider graphs to illustrate the differences between the groups. Spearman rank correlation statistic between corresponding PQRS and COPM items will be conducted to identify relationships between self-rated and therapist-rated assessments of each activity.

To achieve a clinically important mean score difference of 2 points on the COPM, as reported in prior literature (Law et al., 2014), the power calculations using the Kruskal Wallis simulations indicates that a group size of between 15 and 20 are needed to achieve 80% power. Thus, the research aims to recruit a sample size of 80, with approximately 20 in each pattern of vision loss.

Law, M., Baptiste, S., Carswell, A., McColl, M. A., Polatajko, H. J., & Pollock, N. (2014). Canadian occupational performance measure. Ottawa, Ontario: CAOT Publications ACE.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
4/01/2021
Date of last participant enrolment
Anticipated
20/08/2021
Actual
31/03/2022
Date of last data collection
Anticipated
24/08/2021
Actual
31/03/2022
Sample size
Target
80
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22999 0
Singapore
State/province [1] 22999 0

Funding & Sponsors
Funding source category [1] 306744 0
University
Name [1] 306744 0
La Trobe University, Melbourne
Country [1] 306744 0
Australia
Funding source category [2] 307346 0
Hospital
Name [2] 307346 0
Tan Tock Seng Hospital, Singapore
Country [2] 307346 0
Singapore
Primary sponsor type
University
Name
La Trobe University, Melbourne
Address
La Trobe University, Melbourne Campus
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 307296 0
Hospital
Name [1] 307296 0
Tan Tock Seng Hospital, Singapore
Address [1] 307296 0
11 Jalan Tan Tock Seng, Singapore 308433
Country [1] 307296 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306916 0
National Healthcare Group Domain Specific Review Board (Singapore)
Ethics committee address [1] 306916 0
Ethics committee country [1] 306916 0
Singapore
Date submitted for ethics approval [1] 306916 0
Approval date [1] 306916 0
25/08/2020
Ethics approval number [1] 306916 0
2020/00176
Ethics committee name [2] 307433 0
La Trobe University Human Research Ethics Committee (Australia)
Ethics committee address [2] 307433 0
Ethics committee country [2] 307433 0
Australia
Date submitted for ethics approval [2] 307433 0
08/09/2020
Approval date [2] 307433 0
14/09/2020
Ethics approval number [2] 307433 0
2020/00176

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105434 0
Ms Debbie Boey
Address 105434 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng, Singapore 308433
Country 105434 0
Singapore
Phone 105434 0
+6596565303
Fax 105434 0
Email 105434 0
S2Boey@ltu.edu.au
Contact person for public queries
Name 105435 0
Debbie Boey
Address 105435 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng, Singapore 308433
Country 105435 0
Singapore
Phone 105435 0
+6596565303
Fax 105435 0
Email 105435 0
S2Boey@ltu.edu.au
Contact person for scientific queries
Name 105436 0
Debbie Boey
Address 105436 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng, Singapore 308433
Country 105436 0
Singapore
Phone 105436 0
+6596565303
Fax 105436 0
Email 105436 0
S2Boey@ltu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, except for data from the Impact of Visual Impairment (IVI) Questionnaire will be shared, after de-identification. This is because there is a license agreement with the owners of the IVI Questionnaire which indicates that confidential information obtained from the IVI Questionnaire should not be shared with a third party.
When will data be available (start and end dates)?
Immediately following publication, no end dates.
Available to whom?
Researchers on a case-by-case basis at the discretion of Principal Investigator and/or Senior Investigator.
Available for what types of analyses?
Analyses for research related to the original study and/or vision impairment.
How or where can data be obtained?
Access of data is subject to approval from the Principal Investigator (S2Boey@ltu.edu.au) and/or Senior Investigator (L.carey@latrobe.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9920Ethical approval  S2Boey@ltu.edu.au 380594-(Uploaded-01-12-2020-20-30-42)-Study-related document.pdf
9921Other  S2Boey@ltu.edu.au Case report form 380594-(Uploaded-08-12-2020-18-57-56)-Study-related document.docx
12215Informed consent form  S2Boey@ltu.edu.au 380594-(Uploaded-23-06-2021-11-59-02)-Study-related document.doc



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.