Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000043730
Ethics application status
Approved
Date submitted
13/01/2013
Date registered
14/01/2013
Date last updated
16/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Pre-FIT: a multifactorial interdisciplinary treatment program for older people who are pre-frail
Scientific title
Pre-FIT: the effects of an interdisciplinary multifactorial intervention versus usual care on pre-frailty and mobility function in pre frail older people
Secondary ID [1] 281760 0
Nil
Universal Trial Number (UTN)
Trial acronym
Pre-FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre frailty 288074 0
Condition category
Condition code
Physical Medicine / Rehabilitation 288445 288445 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pparticipants in the intervention group will receive a multifactorial, interdisciplinary treatment program intended to target the frailty criteria that are present for a 12-month period following randomisation. The interventions will be individually tailored to each participant based on their frailty characteristics as assessed at baseline, and additional problems as identified during a detailed assessment by experienced physiotherapist(s) providing the intervention program. Geriatric evaluation and management principles will underpin both the assessment and intervention. Case management and regular case conferences will facilitate coordination of intervention delivery. Reassessment will be ongoing throughout the intervention phase.

The intervention is the same as that used in the FIT study. See https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82814
Intervention code [1] 286300 0
Rehabilitation
Intervention code [2] 286301 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive the usual healthcare available to older residents in the Hornsby Ku-ring-gai area from their general practitioner (GP) and community services.
Control group
Active

Outcomes
Primary outcome [1] 288615 0
Pre frailty (which is the presence of one or two of the five Cardiovascular Health Study frailty criteria) will be assessed clinically by a masked trained rater.
Timepoint [1] 288615 0
12 months
Secondary outcome [1] 300597 0
Short Physical Performance Battery (which is a standardised assessment) will be assessed clinically by a masked trained rater.
Timepoint [1] 300597 0
12 months

Eligibility
Key inclusion criteria
- have one or two of the Cardiovascular Health Study frailty criteria, and thus are considered pre-frail;
- have mild or no cognitive impairment (defined as a Mini Mental State Examination score of more than 23).
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- are living in a residential aged care facility;
- have an estimated life expectancy of less than 12 months;
- are currently receiving a treatment program from a rehabilitation facility.

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)
There will be an initial interview at which eligibility is confirmed and informed consent is obtained. Participants will be randomised immediately after this. The study coordinator will telephone an independent person (secretary of the clinical department) for allocation status.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, and stratified by severity of pre-frailty (one criterion or two criteria)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analyses will be conducted on an intention-to-treat basis. Data will be coded to permit blinding to group allocation in the statistical analysis. Frailty criteria will be treated as dichotomous: transitioned to frailty (that is, the number of frailty criteria was 3 or more) or did not transition to frailty (number of frailty criteria was 0. 1 or 2). Other study outcomes as continuous variables. The chi-square test will be used for frailty as a dichotomous variable, and linear regression models with baseline values as a covariate will be used for continuous outcomes. We will report between group differences in percentages, or mean, with 95% confidence intervals at the 4- and 12-month follow-ups. We will test whether the patterns of change in frailty and mobility are modified by the number of frailty criteria present at baseline, by including an interaction term of study groups with frailty criteria at baseline in the regression analyses. Secondary analyses will also be carried out to explore the effect of different rates of adherence (i.e. as a category variable: <25%, 25-49%, 50-75% and >75%) on the outcomes in the intervention group at the 12-month follow-up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2013
Actual
14/01/2013
Date of last participant enrolment
Anticipated
30/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286545 0
Charities/Societies/Foundations
Name [1] 286545 0
Doris Whiting Special Purpose and Trust Fund
Country [1] 286545 0
Australia
Primary sponsor type
Hospital
Name
Division of Rehabilitation and Aged Care
Address
Hornsby Ku-ring-gai Health Service, Palmerston Road, Hornsby NSW 2077
Country
Australia
Secondary sponsor category [1] 285334 0
None
Name [1] 285334 0
Address [1] 285334 0
Country [1] 285334 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288618 0
Northern Sydney Local Health District Health Research Ethics Committee
Ethics committee address [1] 288618 0
c/- Royal North Shore Hospital, St Leonards NSW 2065
Ethics committee country [1] 288618 0
Australia
Date submitted for ethics approval [1] 288618 0
Approval date [1] 288618 0
06/09/2012
Ethics approval number [1] 288618 0
1207-213M

Summary
Brief summary
This is a randomised trial of a multifactorial interdisciplinary intervention for pre frailty. The intervention has previously been shown to be effective in frailty older people (see ACTRN12608000250336, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=82814).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36978 0
Prof Ian Cameron
Address 36978 0
Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney, PO Box 6, Ryde NSW 1680
Country 36978 0
Australia
Phone 36978 0
+61298089236
Fax 36978 0
+61298099037
Email 36978 0
[email protected]
Contact person for public queries
Name 36979 0
Ian Cameron
Address 36979 0
Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney, PO Box 6, Ryde NSW 1680
Country 36979 0
Australia
Phone 36979 0
+61298089236
Fax 36979 0
Email 36979 0
[email protected]
Contact person for scientific queries
Name 36980 0
Ian Cameron
Address 36980 0
Rehabilitation Studies Unit, Royal Rehabilitation Centre Sydney, PO Box 6, Ryde NSW 1680
Country 36980 0
Australia
Phone 36980 0
+61298089236
Fax 36980 0
Email 36980 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1136/bmjopen-2014-007091
N.B. These documents automatically identified may not have been verified by the study sponsor.