Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001102167
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
9/08/2019
Date last updated
23/02/2023
Date data sharing statement initially provided
9/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A falls, balance and bone health clinic: analysis of patient characteristics and outcomes
Scientific title
A falls, balance and bone health clinic: analysis of patient characteristics and outcomes
Secondary ID [1] 298775 0
Nil known
Universal Trial Number (UTN)
U1111-1237-2388
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 313721 0
Condition category
Condition code
Injuries and Accidents 312131 312131 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is a two-part longitudinal, observational study focused on the Falls, Balance and Bone Health clinic at the Prince of Wales hospital, which reviews older adults (aged 65 years and older) that have had a previous fall or are at high risk of falling.

Part 1:
This part of the study will involve a cross-sectional review of retrospective and prospective, re-identifiable data routinely collected from attendees of the Prince of Wales hospital's Falls, Balance and Bone Health clinic. The routine data collected in this clinic is a valuable source of information about adults that have fallen or at risk of falling. The type of data that will be collected includes: demographic information, comorbidities, medications, cognition, mobility, functional ability, social history, bone health history, falls-related outcome measures. The research team will extract the data from the electronic Medical Records (eMR) and clinic notes of attendees. This part of the study does not require any participant involvement. The data will be extracted by members of the research team that work at or are on student placement at the Prince of Wales hospital and routinely have access to this data, therefore participant consent is not required.

Part 2:
This part of the study will involve a follow-up questionnaire with approximately 80 patients whom had attended the Falls, Balance and Bone Health clinic in the previous six to nine months. The aim of this questionnaire is to compare patient attitudes and intentions (questionnaire completed as part of routine attendance when attendees are provided with recommendations from the clinic) to patient actions in relation to falls prevention recommendations. The follow-up questionnaire will be collected at one time-point (six to nine months after clinic attendance) only and should take 10-15 minutes to complete. It will be completed with a member of the research team via telephone. Written consent to be involved in this part of the study will be collected at the attendee's Falls, Balance and Bone Health clinic appointment, and reconfirmed verbally at the time of the telephone call to complete the questionnaire.
Intervention code [1] 315046 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320770 0
Characteristics of patients that attend the Prince of Wales falls, balance and bone health clinic.
Timepoint [1] 320770 0
Date of clinic attendance (data will be extracted within four months of clinic attendance date as per electronic medical records)
Primary outcome [2] 320931 0
Compare patients' attitude and intention towards falls-related recommendations (as assessed by the Attitudes to Falls-Related Interventions Scale) to patient action (as assessed by direct question within purpose-built follow-up questionnaire)
Timepoint [2] 320931 0
Two time points:
T0: At clinic appointment when provided with falls-related intervention recommendation
T1: Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment
Primary outcome [3] 320932 0
Number of falls as assessed by direct questions during clinic appointment and witihin purpose-built follow-up questionnaire
Timepoint [3] 320932 0
Two time points:
T0: At clinic appointment when provided with falls-related intervention recommendation
T1: Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment
Secondary outcome [1] 372783 0
Falls risk as assessed by QuickScreen
Timepoint [1] 372783 0
Date of clinic attendance (data will be extracted within four months of clinic attendance date as per electronic medical records)
Secondary outcome [2] 372938 0
Balance and falls risk as assessed by the Timed Up & Go test
Timepoint [2] 372938 0
Date of clinic attendance (data will be extracted within four months of clinic attendance date as per electronic medical records)
Secondary outcome [3] 372939 0
Gait speed as assessed by the Timed 10m walk test
Timepoint [3] 372939 0
Date of clinic attendance (data will be extracted within four months of clinic attendance date as per electronic medical records)
Secondary outcome [4] 372940 0
Assess fear of falling as assessed by the Falls Efficacy Scale – International (FES-I)
Timepoint [4] 372940 0
Two time points:
T0: At clinic appointment when provided with falls-related intervention recommendation
T1: Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment
Secondary outcome [5] 373386 0
Patient-reported potential barriers to the uptake of falls prevention recommendations as assessed by by direct question within purpose-built follow-up questionnaire
Timepoint [5] 373386 0
Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment
Secondary outcome [6] 373387 0
Patient satisfaction of the Prince of Wales hospital falls, balance and bone health clinic recommendation and/or alternative program as assessed by by direct question within purpose-built follow-up questionnaire.
Timepoint [6] 373387 0
Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment
Secondary outcome [7] 373699 0
Patient acceptability of the Prince of Wales hospital falls, balance and bone health clinic recommendation and/or alternative program as assessed by by direct question within purpose-built follow-up questionnaire.
Timepoint [7] 373699 0
Between six and nine month from date of the Prince of Wales hospital's Falls, Balance and Bone Health clinic appointment

Eligibility
Key inclusion criteria
Part 1 - Routinely collected clinic data analysis:
- All patients that attend the Prince of Wales hospital falls, balance and bone health clinic at least once between 1st February 2019 and 31st July 2021.

Part 2 - Follow-up questionnaire:
- Patients that attend the Prince of Wales hospital falls, balance and bone health clinic at least once between 1st August 2019 and 31st January 2021 (dependent on ethical approval).
- Patients that receive some form of recommendation whilst attending the Prince of Wales hospital falls, balance and bone health clinic.
- Patients that provide written consent to complete a questionnaire approximately six to nine months after their clinic appointment.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Part 1 - Routinely collected clinic data analysis:
- Nil

Part 2 - Follow-up questionnaire:
- Patients that only attend the Prince of Wales hospital falls, balance and bone health prior to 1st August 2019 (dependent on ethical approval).
- Patients that do not require any follow-up intervention after attending the Prince of Wales hospital falls, balance and bone health clinic.
- Patients assessed as having a severe cognitive impairment as per Montreal Cognitive Assessment (MoCA) tool (cut off score: less than 10) during their falls, balance and bone health clinic appointment.
- Patients that do not have sufficient navigation of the English language to be able to answer the questionnaire.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Sample size:
This is a population-based study of all patients that attend the falls, balance and bone health clinic at the Prince of Wales hospital, NSW. Therefore, the proposed number of patients that will be analysed in this study is based on the Prince of Wales hospital falls, balance and bone health clinic attendance rates in previous years; an average of nine patients are seen monthly. In this study, data will be extracted from a 30 months period (01/02/2019-31/07/2021), it is expected that similar attendance rates will be achieved and result in a proposed sample size of 252 patients. Consent to participate in the follow-up questionnaires will not be collected until after ethical approval is granted (01/08/2019-31/01/2021 - dependent on ethical approval), the potential sample size for this element of the study is 80 patients.

Statistical analysis plan:
In order to address the study objectives, descriptive analyses and regression modelling of routinely collected data from the Prince of Wales hospital falls, balance and bone health clinic and follow-up questionnaires will be used to quantitatively examine the associations between study variables, such as patient demographics, physical ability, medications, service use, number of falls, fear of falling, patient’s attitudes and intentions to clinic recommendations, and patient’s actions based on clinic recommendations.

The demographic, health characteristics and falls risk factors of patients attending the clinic will be tabulated. Chi-square tests (for categorical variables) and t-tests (for continuous variables) will be used to compare clinic outcomes (e.g. balance outcome measures) among different patient groups. Outcomes at follow up (e.g. number of falls) will be compared between patients attending different falls prevention activities using negative binomial regression models.

Regression modelling will be used to determine whether patients’ attitudes and intentions (as measured by the AFRIS17) are associated with their participation in falls prevention recommendations, while accounting for other factors that may be associated with participation (e.g. health factors).

Potential barriers to the uptake of clinic recommendations will be examined using thematic analysis of clients’ responses to question in the follow-up questionnaire.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/10/2019
Actual
9/10/2019
Date of last participant enrolment
Anticipated
30/07/2021
Actual
30/07/2021
Date of last data collection
Anticipated
29/04/2022
Actual
20/07/2022
Sample size
Target
252
Accrual to date
Final
194
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14277 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 27273 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 303330 0
Hospital
Name [1] 303330 0
Prince of Wales Hospital (SESLHD)
Country [1] 303330 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital (SESLHD)
Address
Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 303353 0
None
Name [1] 303353 0
Address [1] 303353 0
Country [1] 303353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303862 0
South Eastern Sydney Local Health District HREC LNR Committee
Ethics committee address [1] 303862 0
Ethics committee country [1] 303862 0
Australia
Date submitted for ethics approval [1] 303862 0
20/06/2019
Approval date [1] 303862 0
03/07/2019
Ethics approval number [1] 303862 0
2019/ETH11769

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

Contacts
Principal investigator
Name 95058 0
Dr Lindsey Brett
Address 95058 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 95058 0
Australia
Phone 95058 0
+61 298502487
Fax 95058 0
Email 95058 0
[email protected]
Contact person for public queries
Name 95059 0
Lindsey Brett
Address 95059 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 95059 0
Australia
Phone 95059 0
+61 298502487
Fax 95059 0
Email 95059 0
[email protected]
Contact person for scientific queries
Name 95060 0
Lindsey Brett
Address 95060 0
Department of Health Professions
Faculty of Medicine and Health Sciences
Macquarie University
Ground floor, 75 Talavera Road
Macquarie University
NSW 2109
Country 95060 0
Australia
Phone 95060 0
+61 298502487
Fax 95060 0
Email 95060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Non-identifiable, group data will be presented in publications and reports publicly available only to maintain confidentiality of participants and adhere to requirement of type of consent gained for this study (extended consent).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3240Study protocol    378000-(Uploaded-18-07-2019-14-43-54)-Study-related document.pdf
3241Informed consent form    378000-(Uploaded-18-07-2019-14-44-22)-Study-related document.pdf
3242Statistical analysis plan  [email protected] Will be provided on request
3243Clinical study report    Will be added once study completed
3244Ethical approval    378000-(Uploaded-18-07-2019-14-44-58)-Study-related document.pdf



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.