ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Mental Health

Studies of normal psychology, cognitive function and behaviour

Mental Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Accidental falls (yes/no; binary outcome). Recorded via the online diary.

Timepoint [1]

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]

Accidental falls (n; integer). Recorded via the online diary.

Timepoint [2]

Secondary outcome [1]

UCLA Loneliness Scale

Timepoint [1]

Every 13 weeks (0, 13, 26, 39, 52 weeks)

Secondary outcome [2]

Short Form (SF-8) Health Survey

Timepoint [2]

Every 13 weeks (0, 13, 26, 39, 52 weeks)

Secondary outcome [3]

Physical Activity Scale for the Elderly (PASE)

Timepoint [3]

Every 13 weeks (0, 13, 26, 39, 52 weeks)

Secondary outcome [4]

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]

Every 13 weeks (0, 13, 26, 39, 52 weeks)

Secondary outcome [5]

Fear of Falling Questionnaire – Revised (FFQ-R)

Timepoint [5]

Every 13 weeks (0, 13, 26, 39, 52 weeks)

Secondary outcome [6]

Depression Anxiety Stress Scale (DASS-21)

Timepoint [6]

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

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country [1]

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]

Individual

Name [1]

Dr. Mark W. Creaby

Address [1]

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr. Michael H. Cole

Address [2]

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/10/2021

Ethics approval number [1]

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

A/Prof Gert-Jan Pepping

Address

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country

Australia

Phone

+61 7 36237550

Fax

gert-jan.pepping@acu.edu.au

Contact person for public queries

Name

Gert-Jan Pepping

Address

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country

Australia

Phone

+61 7 36237550

Fax

STOPFalls@acu.edu.au

Contact person for scientific queries

Name

Gert-Jan Pepping

Address

Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland. 4014.

Country

Australia

Phone

+61 7 36237550

Fax

gert-jan.pepping@acu.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?

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 (gert-jan.pepping@acu.edu.au), 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.

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