Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000760976
Ethics application status
Approved
Date submitted
29/05/2020
Date registered
24/07/2020
Date last updated
6/07/2024
Date data sharing statement initially provided
24/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title

Evaluation of the effect of tailored frailty interventions aimed at addressing frailty in older people: Frailty in Older people, Rehabilitation Treatment, Research Examining Separate Settings - The FORTRESS study.
Scientific title
Evaluation of personalised frailty intervention strategies determined by screening frailty traits in older people during an acute hospital admission: Frailty in Older people Rehabilitation Treatment, Research Examining Separate Settings- The FORTRESS study.
Secondary ID [1] 301342 0
NHMRC
Application ID: APP1177847
Universal Trial Number (UTN)
U1111-1252-3828
Trial acronym
FORTRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty in older people 317561 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315647 315647 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 315901 315901 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A frailty management plan will be devised while the participant is in hospital based on the FRAIL scale score. It will be a personalised intervention strategy that may include targeted physical exercises, dietary supplements and de-prescribing of poly-pharmacy. It will differ from participant to participant according to individual need. There will be facilitation and support of this intervention upon discharge from hospital by a community implementation facilitator. Participants will be discharged home with a set of exercises tailored to their needs. Some will have supplements or have been prescribed a high energy/high protein diet. They will be asked to do the exercises daily (or as often as possible) and to document when they have done so on a calendar. Similarly they will be asked to self report on their adherence to any dietary recommendations. The community facilitator will visit the participant only once or twice, but will also engage with the GP as it is expected the GP will encourage and support the participant with the frailty management plan in the community going forward.

The intervention strategy is prescribed on the ward (jointly) by the Physiotherapist (exercise program), the Dietician (appropriate dietary intervention) and the Pharmacist (poly pharmacy) dependent on the participant needs as highlighted in the FRAIL Scale. The Implementation Clinician, assists with ensuring adherence to the intervention while the participant is in hospital and the Community Implementation Facilitator will engages with the participant and the GP in the community.

The overall duration of the intervention is 12 months from date of recruitment with outcome assessments at 3 months and at 12 months.

The first community facilitator visit will occur as soon as practicable following discharge at a date and time mutually agreed upon between the facilitator and the participant. There may be up to two further visits, depending on need. If a subsequent visit or visits are required these will occur at a time deemed most appropriate by the facilitator (ie - it may be based on a request by the participant, the GP or a significant other, or it may be arranged at the time of the first visit). There is flexibility around this, as it is thought that some participants will require more support than others to adhere to the management plan, and some participants have less home support than others. The nature of these visits will also depend on the individual but are about ensuring the management plan is transitioned smoothly into the community and participants are able to adhere to it at home. The facilitator will ensure exercises and dietary recommendations are being followed as prescribed and liaise back to the Implementation Clinicians (at the hospital) for adjustments or advice if necessary. They also will liaise with the GP to encourage support for the plan.
Intervention code [1] 317641 0
Rehabilitation
Comparator / control treatment
The study will use a hybrid type III trial approach which allows testing of the implementation strategy (Implementation Facilitation) at the same time as observing the outcomes of the intervention (screening for frailty and use of appropriate interventions). The study design will be a randomised stepped wedge design with interventions being commenced at FOUR-month intervals in six wards in two hospitals (one in NSW and one in SA). During the first four months all 6 participating wards will act as control wards with no interventions taking place. In the second 4-month period two of the wards will start receiving the intervention. In the third 4-month period 4 wards will receive the intervention, and in the final 4 months all six wards will be intervention wards. Those participants who are controls will receive 'usual care' which may well include physiotherapy and dietary components, however it will not be an intervention designed to specifically target frailty. All controls and interventions will be followed up in the community by a masked outcome assessor at 3 and 12 months post recruitment in hospital.
Control group
Active

Outcomes
Primary outcome [1] 323882 0
Any change in non-elective hospital re-admissions as determined by data-linkage to hospital records
Timepoint [1] 323882 0
Hospital re-admissions will be recorded at 3 and 12 months post-enrolment.
Secondary outcome [1] 383145 0
Change in the overall Frailty status score as measured using the validated FRAIL Scale at 3 and 12 months post-enrolment.
Timepoint [1] 383145 0
FRAIL scale will be measured at baseline (enrolment), and at 3 and 12 months post-enrolment.
Secondary outcome [2] 383146 0
Change in the total Quality of Life Score as measured using the EQ-5D-5L
Timepoint [2] 383146 0
EQ-5d-5L will be measured at baseline (enrolment), and at 3 and 12 months post-enrolment.

Eligibility
Key inclusion criteria
To be eligible to participate in the FORTRESS study people must:

1) be aged 75 years and over, with an estimated life expectancy of more than 12 months, estimated by a score 1 or 2 on a modified version of the Illness Severity Rating
2) have been admitted to an acute medical or rehabilitation ward in Hornsby Ku-ring-gai Hospital in northern Sydney, or Flinders Medical Centre in southern Adelaide
3) have been assessed as frail (using the FRAIL Scale Risk Assessment Tool) by the FORTRESS study Implementation Clinician (scored equal to or greater than 3 on this scale).
4) be living at home in the community prior to hospitalisation (ie they did not reside in an Aged Care Facility)
5) be able to cooperate with suggested interventions as assessed by the Implementation Clinician or other allied health staff (attain a score of 18 or more on the Mini Mental State Examination (MMSE)
Minimum age
75 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for FORTRESS include:

1) People admitted to hospital with stroke. (People with acute stroke are admitted to specialised units in both participating hospitals).
2) People who are not frail or screen as pre-frail (a score of less than 3 on the FRAIL Scale)
3) People who are unable to cooperate with intervention program (cognitive impairment per se is not an exclusion criteria but older people with moderately severe dementia or a score of less than 18 in the Mini Mental State Examination (MMSE) may not be able to participate)
4) People aged less than 75 years of age
5) People who were not mobile prior to admission (unable to walk without the assistance of another person)
6) People with a life expectancy of less than 12 months, estimated by a score of 3 or more on a modified version of the Illness Severity Scale
7) People who reside in a residential aged care facility
8) People who have already been recruited into the study when admitted to another participating ward

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The ward randomisation allocation will be carried out by the FORTRESS study bio-statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Transition to intervention phase will be randomised by ward with stratification by site and using minimisation with a random component to address the potential for baseline and sequential balance. An adaptation of a dynamic (adaptive) random allocation method such as minimisation will be used for sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The study will use a hybrid type III trial approach which allows testing of the implementation strategy (Implementation Facilitation) at the same time as observing the outcomes of the intervention (screening for frailty and use of appropriate interventions). The study design will be a randomised stepped wedge design with interventions being commenced at FOUR-month intervals in six wards in two hospitals (one in NSW and one in SA). During the first four months all 6 participating wards will act as control wards with no interventions taking place. In the second 4-month period two of the wards will receive the intervention. In the third 4-month period, 4 wards will receive the intervention, and in the final 4 months, all six wards will be intervention wards.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The anticipated enrolment is approximately 732 participants from the six wards over 16 months allowing for approximately 10% drop out and 10% mortality, with this sample size we will be able to detect a difference between control and intervention conditions of 25% vs 15% readmissions at 3 months, and 50% vs 35% readmissions at 12 months using time to event analysis of readmission, with 80% power and 5% significance level, allowing for a design effect of 1.5.

It is anticipated that one third of the participants will be recruited from South Australia and approximately two thirds will be recruited from NSW.

The primary analyses with reference to non-elective hospital readmissions will be time to event analyses using a survival analysis approach. Readmissions will be adjudicated as non-elective / elective by an adjudication committee independent of the investigators.
The secondary analyses will use linear mixed models with adjustment for credible confounders including age, gender and cognitive status (noting that cognitive status is now routinely assessed at and during hospital admission to meet the National Safety and Quality Health Service Standards 2nd Edition).

The analyses will be supervised by the study statistician.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2020
Actual
2/09/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
31/01/2023
Date of last data collection
Anticipated
31/01/2024
Actual
6/12/2023
Sample size
Target
732
Accrual to date
Final
539
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 16729 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [2] 16730 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30332 0
2077 - Hornsby
Recruitment postcode(s) [2] 30333 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305783 0
Government body
Name [1] 305783 0
National Health and Medical Research Council (NHMRC)
Country [1] 305783 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown, NSW 2006
Country
Australia
Secondary sponsor category [1] 306221 0
None
Name [1] 306221 0
Address [1] 306221 0
Country [1] 306221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306057 0
Northern Sydney Local Health District Human Research Ethics Comittee
Ethics committee address [1] 306057 0
Ethics committee country [1] 306057 0
Australia
Date submitted for ethics approval [1] 306057 0
09/06/2020
Approval date [1] 306057 0
19/08/2020
Ethics approval number [1] 306057 0
2020/ETH01057

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

Contacts
Principal investigator
Name 102546 0
Prof Susan Kurrle
Address 102546 0
Department of Rehabilitation and Aged Care
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country 102546 0
Australia
Phone 102546 0
+61 2 9477 9245
Fax 102546 0
Email 102546 0
[email protected]
Contact person for public queries
Name 102547 0
Keri Lockwood
Address 102547 0
Rehabilitation and Aged Care Clinical Trials Unit
Old Leighton Lodge
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country 102547 0
Australia
Phone 102547 0
+61 2 9477 9225
Fax 102547 0
Email 102547 0
[email protected]
Contact person for scientific queries
Name 102548 0
Susan Kurrle
Address 102548 0
Department of Rehabilitation and Aged Care
Hornsby Ku-ring-gai Hospital
Palmerston Road
Hornsby NSW 2077
Country 102548 0
Australia
Phone 102548 0
+61 2 9477 9245
Fax 102548 0
Email 102548 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?
All de-identified data will be made available
When will data be available (start and end dates)?
The data will be available following our groups peer reviewed publications/outputs. No end date, available yet, but it will be available for at least 5 years after publication
Available to whom?
Available on request to medical researchers and clinicians
Available for what types of analyses?
Available for research analyses related to the health of older people
How or where can data be obtained?
The data can be obtained by emailing Professor Susan Kurrle ([email protected]), the project Principal Investigator, following completion of outputs.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8034Study protocol  [email protected] Available by email on request



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFrailty in older people: Rehabilitation Treatment Research Examining Separate Settings (FORTRESS): protocol for a hybrid type II stepped wedge, cluster, randomised trial.2022https://dx.doi.org/10.1186/s12877-022-03178-1
EmbaseImplementation of a frailty intervention in the transition from hospital to home: A realist process evaluation protocol for the FORTRESS trial.2023https://dx.doi.org/10.1136/bmjopen-2022-070267
N.B. These documents automatically identified may not have been verified by the study sponsor.