Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001581853
Ethics application status
Approved
Date submitted
11/10/2021
Date registered
19/11/2021
Date last updated
15/12/2021
Date data sharing statement initially provided
19/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
STOP Falls: Effects of Social Interaction on Physical Activity, Quality of Life and Falls in Older Adults
Scientific title
STOP Falls: Effects of Social Interaction on Physical Activity, Quality of Life and Falls in Older Adults
Secondary ID [1] 302017 0
None
Universal Trial Number (UTN)
Trial acronym
STOP Falls: Study Towards Opportunities for the Prevention of Falls
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 318581 0
Condition category
Condition code
Injuries and Accidents 316592 316592 0 0
Other injuries and accidents
Mental Health 316593 316593 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 316594 316594 0 0
Anxiety

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational cohort study will prospectively follow apparently healthy older adult participants over 52 weeks, with questionnaires completed via REDCap at baseline and every 13-weeks (i.e. 4 follow-up timepoints). Completion of the baseline and follow-up questionnaires are expected to take ~30 minutes each. Participants will also complete an ongoing online diary in REDCap over the duration of study participation to record the occurrence and nature of any accidental falls they experience. Completion of the diary is expected to take ~5 minute per fall or when no falls are experienced 5 minutes every 4 weeks.
The baseline and 4 follow-up questionnaires will assess constructs of social interaction, physical and mental health, physical activity and fear of falling.
Intervention code [1] 318308 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329203 0
Accidental falls (yes/no; binary outcome). Recorded via the online diary.
Timepoint [1] 329203 0
Across the 52-week duration of participation. Diary entries can be logged as frequently as desired by the participant i.e. every fall can be logged as soon as it occurs. Participants will be prompted via email at the end of each 4-week period to ensure their data is complete for that period.
Primary outcome [2] 329204 0
Accidental falls (n; integer). Recorded via the online diary.
Timepoint [2] 329204 0
Across the 52-week duration of participation. Diary entries can be logged as frequently as desired by the participant i.e. every fall can be logged as soon as it occurs. Participants will be prompted via email at the end of each 4-week period to ensure their data is complete for that period.
Secondary outcome [1] 401775 0
UCLA Loneliness Scale
Timepoint [1] 401775 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)
Secondary outcome [2] 401776 0
Short Form (SF-8) Health Survey
Timepoint [2] 401776 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)
Secondary outcome [3] 401777 0
Physical Activity Scale for the Elderly (PASE)
Timepoint [3] 401777 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)
Secondary outcome [4] 401778 0
Two-question Fear of Falling questionnaire. As used by Friedman et al (2002). To our knowledge this questionnaire has not previously been validated.

Friedman SM, Munoz B, West SK, Rubin GS, Fried LP. Falls and fear of falling: Which comes first? A longitudinal prediction model suggests strategies for primary and secondary prevention. Journal of the American Geriatrics Society; 2002 Aug;50(8):1329–35.
Timepoint [4] 401778 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)
Secondary outcome [5] 401779 0
Fear of Falling Questionnaire – Revised (FFQ-R)
Timepoint [5] 401779 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)
Secondary outcome [6] 401780 0
Depression Anxiety Stress Scale (DASS-21)
Timepoint [6] 401780 0
Every 13 weeks (0, 13, 26, 39, 52 weeks)

Eligibility
Key inclusion criteria
(i) aged over 65 years;
(ii) be free of any significant health conditions that adversely affect their balance or mobility;
(iii) have the ability to walk independently for short time periods, and
(iv) have normal or corrected to normal vision.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have any self-reported signs of cognitive and/or neurological decline.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
To address the primary aim, a falls prediction model that includes measures of social interaction, physical activity, quality of life and fear of falling, while also considering the influence of the participants’ age, gender, geographical location, level of support, self-reported walking speed and comorbidities (10 predictors) will be developed. To avoid model over-fitting, at least 10 participants who record a fall will be required for every predictor variable included in the logistic regression model (i.e. =100 fallers). According to previous prospective research, 33% of community-dwelling older adults over the age of 65 will fall at least once in a 52-week period (Hill et al., 2004); hence, a minimum of 300 participants will be required to meet this target. Given the prospective nature of this research, the proposed minimum sample of 360 community-dwelling older adults includes a conservative rate of attrition (20%) to account for participant withdrawal during the 12-month follow-up period and/or a lower than average falls incidence. To reach a sufficient number of participants and a balanced sample size in terms of the specific predictor variables included in the final model, as well as the possibility of a higher than estimated dropout rate, recruitment will remain open beyond meeting the initial target of 360 participants.
References:
Hill K, Vrantsidis F, Haralambous B, Fearn M, Smith R, Murray K, Sims J, Dorevitch, M. An analysis of research on preventing falls and falls injury in older people: Community, residential care and hospital settings. Australian Government Department of Health and Ageing: Canberra, AU. 2004.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/11/2021
Actual
3/12/2021
Date of last participant enrolment
Anticipated
28/04/2023
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
360
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309888 0
University
Name [1] 309888 0
Australian Catholic University
Country [1] 309888 0
Australia
Primary sponsor type
Individual
Name
A. Prof. Gert-Jan Pepping
Address
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country
Australia
Secondary sponsor category [1] 307912 0
Individual
Name [1] 307912 0
Dr. Mark W. Creaby
Address [1] 307912 0
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country [1] 307912 0
Australia
Secondary sponsor category [2] 311133 0
Individual
Name [2] 311133 0
Dr. Michael H. Cole
Address [2] 311133 0
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country [2] 311133 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306646 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 306646 0
Manager, Ethics and Integrity
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 306646 0
Australia
Date submitted for ethics approval [1] 306646 0
Approval date [1] 306646 0
08/10/2021
Ethics approval number [1] 306646 0
2020-131H

Summary
Brief summary
Accidental falls are a costly public health problem and can result in significant negative implications for the individual, particularly when resulting in injury and hospitalisation. A range of factors are known to influence one’s risk of accidental falls, including age, physical activity, quality of life, fear of falling and social interaction/isolation. In an era of rapid changes in the way we socially interact and/or isolate, this may have important implications for falls risk. Thus, the aim of this observational study is to examine the predictive effect of social interaction, physical activity levels, quality of life and fear of falling on falls incidence in older adults.
Trial website
https://www.acu.edu.au/about-acu/faculties-directorates-and-staff/faculty-of-health-sciences/school-of-behavioural-and-health-sciences/research/STOPFalls
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104538 0
A/Prof Gert-Jan Pepping
Address 104538 0
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country 104538 0
Australia
Phone 104538 0
+61 7 36237550
Fax 104538 0
Email 104538 0
[email protected]
Contact person for public queries
Name 104539 0
A/Prof Gert-Jan Pepping
Address 104539 0
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country 104539 0
Australia
Phone 104539 0
+61 7 36237550
Fax 104539 0
Email 104539 0
[email protected]
Contact person for scientific queries
Name 104540 0
A/Prof Gert-Jan Pepping
Address 104540 0
Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.
Country 104540 0
Australia
Phone 104540 0
+61 7 36237550
Fax 104540 0
Email 104540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data for baseline and follow-up questionnaires and accidental falls diaries.
When will data be available (start and end dates)?
Following the conclusion of the study, for a period of at least 5 years.
Available to whom?
Scientific researchers. Approval may be on a case-by-case basis.
Available for what types of analyses?
Scientific research where there is an intent to publish the findings.
How or where can data be obtained?
Via the Principal Investigator ([email protected]), or via a suitable data scientific repository (not yet determined).


What supporting documents are/will be available?

No Supporting Document Provided



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.