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The impact of the Stroke Action Falls program on Falls In Stroke Survivors

A randomised controlled trial to evaluate the clinical and cost effectiveness of the Stroke Action Falls rehabilitation program compared to usual care alone to reduce Falls In Stroke Survivors - the FISS-Australia trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001121459
Acronym
FISS (Falls In Stroke Survivors)
Enrollment
464
Registered
2025-10-13
Start date
2026-02-09
Completion date
2027-08-09
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stroke is a serious health condition that can affect people of all ages, often leading to long-term challenges. One concern after a stroke is the risk of falling. In Australia, falls are the leading cause of hospital stay due to injuries resulting from falls and not only are costly to the healthcare system but can impact on people’s independence and participation in meaningful life activities. For people with stroke, the risk of falling is even higher—about 75 percent will experience a fall, usually at home, within the first year after their stroke. This can lead to injuries, hospital visits, and a loss of confidence in daily life. We need strong evidence on the best ways to prevent falls after stroke. A program called Action Falls has been shown to reduce falls by 43 percent in older adults living in nursing homes. FISS - Australia trial will test whether Stroke Action Falls (Action Falls adapted for people who have had a stroke) along with usual care reduces falls in people living in the community following their stroke. The trial will evaluate the clinical and cost-effectiveness of the Stroke Action Falls intervention from the perspective of patients and their carers (clinicians and significant others) via participant reported questionnaires as well as interview data for a sample of participants who have received the Stroke Action Falls intervention.

Interventions

Usual care plus Stroke Action Falls (SAF) Usual care Usual care is the care prescribed by the participant's healthcare team that may include community rehabilitation services that the participants may be referred to after they leave the hospital such as physiotherapy, occupational therapy, general practitioner visits or other routine post-stroke healthcare. SAF program (intervention) The SAF Intervention is an expert-led, self-management approach to reduce falls, guided by a SAF checklist, w

Usual care plus Stroke Action Falls (SAF) Usual care Usual care is the care prescribed by the participant's healthcare team that may include community rehabilitation services that the participants may be referred to after they leave the hospital such as physiotherapy, occupational therapy, general practitioner visits or other routine post-stroke healthcare. SAF program (intervention) The SAF Intervention is an expert-led, self-management approach to reduce falls, guided by a SAF checklist, which is used to identify risks and actions to address identified risks. Significant others such as carers or family members may be involved in SAF sessions. Participants receive an education booklet, specifically designed for this study, and the completed SAF checklist and action plan which is individualised for each participant with stroke. The SAF checklist outlines the definition of a fall, risk factors, and suggested actions across key areas such as falls history, medical history, and home environment. The action plan is personalised for each participant based on their individual risks, which are identified during the initial SAF session. The SAF checklist and action plan serves as a reminder of the actions and allows them to track their progress. Registered, SAF trained health care professionals will deliver SAF to trial participants either in their home or via telehealth depending on their preference and location (for a home visit participant residence must be less than or equal to one hour from where the SAF clinician is based). Participants in the intervention arm receive three scheduled sessions, including an initial session within two weeks of randomisation, a follow-up phone call within four weeks, and a third session six months after randomisation. A fourth session may be triggered if the participant reports that they have had a fall or changed residence during the first six months. Session 1 (within two weeks of randomisation) The session will take about an hour to complete. Participant will be provided with the education booklet, SAF checklist and action plan and work with participants and significant others (where appropriate), to review the SAF checklist and identify appropriate actions. Participants will be advised to contact their SAF clinician if they fall or move residence during the first six months of their trial participation. This participant-initiated contact will trigger an additional SAF session (see description for triggered session). Session 2 (within four weeks of randomisation) Two weeks after the initial session, the SAF clinician will phone the participant to check on their progress by reviewing progress on completion of actions that were identified during the initial session and discuss provide guidance as necessary with regards to unresolved actions. The session will take about 30 minutes to complete. Session 3 (six months post randomisation) Six months after randomisation the SAF clinician will complete a SAF session with the participant where they will work with participants and significant others (where appropriate) and use the SAF checklist to review risks and relevant actions, to update the participant’s action plan. The session will take about an hour to complete. Triggered session (following notification of fall or change of residence) Where a SAF clinician receives notification from a participant of a fall or a change of residence, the SAF clinician will contact the participant to arrange an additional SAF session to review and update their action plan using the SAF checklist. If the participant has not moved residence since their first SAF session, this follow-up session will be conducted by telehealth or at the participant's home (for a home visit participant residence must be less than or equal to one hour from where the SAF clinician is based). Adherence to SAF intervention delivery will be monitored by completion of a SAF session record by clinicians at the end of each SAF session, capturing details of the session (i.e. completion of risk and action identification according to the checklist, session date and duration). A sample of recorded SAF sessions will be independently reviewed to enable fidelity checking.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years or over * Admitted to hospital following a stroke * Either planned to be discharged home from hospital (including group home or somebody else's home) or discharged home within the previous 12 months * Able to report number of falls and complete study questionnaires (either participant or carer or family member) * Able to provide consent either individually or via a legally authorised representative, in accordance with relevant state or territory legislation. * Willing to receive SAF via tele-rehabilitation or reside within 1 hr driving distance from SAF clinician * For those opting for or needing SAF delivery via tele-rehabilitation - Access to a smart mobile phone or tablet or computer capable of supporting telehealth video communications

Exclusion criteria

* Resident of, or being discharged to, a residential aged care facility * On end-of-life pathway or life expectancy less than 12 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026