Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001103651
Ethics application status
Approved
Date submitted
22/09/2023
Date registered
20/10/2023
Date last updated
20/10/2023
Date data sharing statement initially provided
20/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty in Older people: Rehabilitation Treatment Research Examining Separate Settings PLUS. (FORTRESS Plus)
Scientific title
Frailty in Older people: Rehabilitation Treatment Research Examining Separate Setting PLUS (FORTRESS Plus) on quality of life in frail older people (70 years and over).
Secondary ID [1] 310663 0
None
Universal Trial Number (UTN)
Trial acronym
FORTRESS Plus
Linked study record
ACTRN12620000760976 is being used as a historical control. The intervention group from ACTRN12620000760976 will be compared against the age matched participants from the FORTRESS Plus cohort in terms of the primary outcome of EQ-5D-QOL score.

Health condition
Health condition(s) or problem(s) studied:
Frailty 331564 0
Condition category
Condition code
Physical Medicine / Rehabilitation 328300 328300 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group from the previously registered FORTRESS (Frailty in Older People Rehabilitation Treatment Research Examining Separate Settings) study will act as a control group for the FORTRESS Plus study. Intervention has been completed for the FORTRESS participants. The 12-month outcome assessments for the FORTRESS study will be complete in January 2024. Results for the FORTRESS project will be available at that time point however data analysis and comparison between FORTRESS and FORTRESS Plus will not occur until both projects have completed the final outcome assessments. Eligibility criteria for FORTRESS Plus will be the same as for FORTRESS. Recruitment will occur from the same wards in the same hospital with patients from the same jurisdiction. There will be an “opt out” approach to the study, automatically including all patients in participating wards over the age of 70 in the FORTRESS Plus study, unless they specifically ask to be excluded (this aligns with FORTRESS study recruitment except the FORTRESS Study also excluded people aged 70-74 inclusive). All frailty interventions are based on the Asia Pacific Clinical Practice Guidelines for the Management of Frailty and therefore are consistent with standard care. Recruitment for FORTRESS Plus will be across 6 months and there will be outcome assessments completed for all participants at 4 months and 12 months from the point of recruitment. The study is anticipated to take 20 months in total.
During the acute admission, the study Pharmacist will record the Drug Burden Index (DBI) and any recommendations regarding review or deprescribing for each participant. The study pharmacist will review these medications again at 12 months. During the acute admission, the participant will be seen by the hospital dietician if they have indicated a 5kg or 5% loss of weight over the past 12 months and receive education on protein fortification and supplementation. The participant will also be seen by the ward Geriatrician from the Acute Care of the Elderly Team (ACE) for encouragement of Vitamin D supplementation. This will be a face to face discussion. If the participant is found to be deficient in Vitamin D and they are recommended to take a supplement the recommended dosage is 800 - 1000 IU. A basic Frailty Management Plan will be devised to inform the GP of the recommendations made by these clinicians during the patient’s acute admission.
Upon discharge home into the community, the participant will be seen by the FORTRESS Exercise Physiologist. The participants will receive up to 7 weekly visits to their home for supervised exercise by an exercise physiologist who will design an individualised exercise program and encourage adherence to any recommendations made by the hospital dietician or/and pharmacist. The duration of the visits will be tailored to depending on individual need but is anticipated to be 30 to 60 minutes per visits. The initial home visit will occur approximately one week post discharge and be a longer visit closer to 90 minutes due to the baseline physical measures that need to be taken using the SPPB (Short Physical Performance Battery Test). The exercise program will consist of resistance and balance exercises adapted from the Otago handbook. In addition to this, group exercise classes that are frailty-specific or other outpatient group exercises may be arranged by the exercise physiologist if deemed appropriate. Motivational interviewing will be conducted at the first initial home visit and is anticipated to take 20 minutes out of the 90-minute session. This will be used to determine stage of behaviour change, and to set goals specific to the participant to inform the prescription of exercises. The carer or next of kin will be contacted and the participants involvement in the study explained to them. It is important to involve significant others to enhance mood and promote adherence. Adherence will be monitored through an exercise calendar which is provided to each participant and where they will be asked to record the details (duration, which exercises were completed) of their self initiated exercise sessions as well as any group exercise classes they are attending.
Intervention code [1] 327070 0
Treatment: Other
Comparator / control treatment
The FORTRESS intervention group will be used as the CONTROL group for the FORTRESS Plus study. This data was collected starting 01/10/2020 and is anticipated to be complete 31/01/2024. Comparison between the two cohorts (FORTRESS and FORTRESS Plus) will not occur until the final outcome assessments for FORTRESS Plus are complete. The final outcome assessment completion date is anticipated to be 31/10/2024.
Control group
Historical

Outcomes
Primary outcome [1] 336151 0
Quality of Life
Timepoint [1] 336151 0
Baseline, 4 months post recruitment, 12 months post recruitment.
Secondary outcome [1] 427091 0
Frailty Status
Timepoint [1] 427091 0
Baseline, 4 months post recruitment, 12 months post recruitment.
Secondary outcome [2] 427618 0
Physical Outcomes
Timepoint [2] 427618 0
Baseline (initial home visit), 4 months and 12 month outcome assessment time points

Eligibility
Key inclusion criteria
To be eligible to participate in the FORTRESS Plus Study, people must be:
Aged 70 years and over.
Admitted to the study wards at Hornsby Ku-ring-gai Hospital (2D, 3D and 4D)
Assessed as frail (using the FRAIL Scale Risk Assessment Tool) by the FORTRESS Clinician (scored 3 or greater on this scale)
Reside at home in the community within the NSLHD catchment area (i.e., do not reside in a Residential Aged Care Facility)
Have achieved a score of 22 or more on the MMSE (in the last 2 months)
Be English speaking.

Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The following patients will be excluded from the FORTRESS Plus study:
People admitted to hospital with a new stroke (during the indexed admission).
People who are not frail (i.e., score less than 3 on the FRAIL Scale)
People who have an estimated life expectancy of less than 12 months (as determined by The Illness Severity Rating Scale)
People who are unable to cooperate with an intervention program.
People aged less than 70 years.
Those unable to walk without the assistance of one other person.
Anyone who resides in a Residential Aged Care Facility
Participants who were recruited into the FORTRESS study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome will be the difference in EQ-5D-5L outcomes of intervention between the FORTRESS Plus pilot study and FORTRESS as a historical comparison. EQ-5D-5L outcomes of intervention, and the difference between pre- and post-intervention assessments of EQ-5D-5L summary index, will be examined independently within each study using generalised linear mixed models. Primary analyses will use the intention-to-treat approach. Mixed modelling implicitly handles missing follow up data based on a missing at random assumption. Direct comparison of FORTRESS Plus participants with FORTRESS intervention participants will also be examined using inverse probability weighting for key baseline prognostic factors. Secondary outcomes will be examined in a similar manner.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2023
Actual
Date of last participant enrolment
Anticipated
2/04/2024
Actual
Date of last data collection
Anticipated
2/04/2025
Actual
Sample size
Target
106
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25576 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 41398 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 314881 0
Hospital
Name [1] 314881 0
Doris Whiting Trust Fund
Country [1] 314881 0
Australia
Funding source category [2] 314885 0
Charities/Societies/Foundations
Name [2] 314885 0
North Foundation (Charity)
Country [2] 314885 0
Australia
Funding source category [3] 314886 0
University
Name [3] 314886 0
John Walsh Centre for Rehabilitation Research
Country [3] 314886 0
Australia
Primary sponsor type
Hospital
Name
Hornsby Ku-ring-gai Hospital
Address
Palmerston Road, Hornsby, NSW 2077
Country
Australia
Secondary sponsor category [1] 316883 0
None
Name [1] 316883 0
Address [1] 316883 0
Country [1] 316883 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313879 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313879 0
Ethics committee country [1] 313879 0
Australia
Date submitted for ethics approval [1] 313879 0
22/08/2023
Approval date [1] 313879 0
05/09/2023
Ethics approval number [1] 313879 0
2023/ETH00649

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

Contacts
Principal investigator
Name 129646 0
Prof Susan Kurrle
Address 129646 0
Hornsby Ku-ring-gai Hospital, Palmerston Road, Hornsby, NSW 2077
Country 129646 0
Australia
Phone 129646 0
+61 294779245
Fax 129646 0
Email 129646 0
[email protected]
Contact person for public queries
Name 129647 0
Keri Lockwood
Address 129647 0
Hornsby Ku-ring-gai Hospital, Palmerston Road, Hornsby, NSW 2077
Country 129647 0
Australia
Phone 129647 0
+61 421747231
Fax 129647 0
Email 129647 0
[email protected]
Contact person for scientific queries
Name 129648 0
Susan Kurrle
Address 129648 0
Hornsby Ku-ring-gai Hospital, Palmerston Road, Hornsby, NSW 2077
Country 129648 0
Australia
Phone 129648 0
+61 294779245
Fax 129648 0
Email 129648 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
This study has an "opt in" Ethics approval. This means that all people admitted to the acute study wards will be included in the project unless they decide to opt out. This is because the intervention being applied is considered as best practice as laid out by the 2017 Asia Pacific Guidelines for the Management of Frailty. Because of this we would need to seek individual approval of all participants to share their data. As yet researchers have not yet planned to do this. This could change.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20457Study protocol  [email protected]
20458Statistical analysis plan  [email protected]
20459Ethical approval  [email protected]



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.