Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000054617
Ethics application status
Approved
Date submitted
29/07/2005
Date registered
29/07/2005
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Date results information initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Falls Assessment Clinical Trial
Scientific title
Falls Assessment Clinical Trial: randomised controlled trial of a multi-component intervention in primary health care to reduce falls amongst over 75 year old adults with a history of falling
Secondary ID [1] 305924 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls in older adults 125 0
Condition category
Condition code
Public Health 140 140 0 0
Other public health
Injuries and Accidents 141 141 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-month home-based intervention (includes):
-Falls risk factor health assessment and referral to appropriate health professional where required
-Home hazards assessment
- Bone health assessment
-Otago Exercise Programme
Intervention code [1] 78 0
Prevention
Comparator / control treatment
Control (includes):
-Offer of at least two social visits
-Usual care from general practitioner
-Written falls prevention pamphlet
Control group
Placebo

Outcomes
Primary outcome [1] 181 0
Falls
Timepoint [1] 181 0
Information collected monthly over 12 months
Secondary outcome [1] 386 0
Physical activity (AHS physical activity questionnaire)
Timepoint [1] 386 0
Collected at baseline and 12 months
Secondary outcome [2] 387 0
Fear of falling (modified fear of falling scale)
Timepoint [2] 387 0
Collected at baseline and 12 months
Secondary outcome [3] 388 0
Quality of life (SF36)
Timepoint [3] 388 0
Collected at baseline and 12 months
Secondary outcome [4] 389 0
Muscle strength and balance (Timed up and go, sit to stand, FICSIT balance, and step tests)
Timepoint [4] 389 0
Collected at baseline and 12 months
Secondary outcome [5] 390 0
Activities of daily living (Nottingham extended ADL questionnaire).
Timepoint [5] 390 0
Collected at baseline and 12 months
Secondary outcome [6] 391 0
Institutionalisation and injury
Timepoint [6] 391 0
Recorded monthly

Eligibility
Key inclusion criteria
Adults aged 75 years and older (over 55 years amongst Maori and Pacific people), who have had a fall in the last 12 months, identified within primary health care.
Minimum age
75 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comprehend study information and consent processes, unstable or progressive medical condition, severe physical disability, or dementia.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer randomisation and allocation of randomisation at a distant independent site, following baseline assessment. Baseline and outcome assessors remain blind to allocation of randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence of treatments was obtained from STATA. The randomisation allocation was stratified by participating practice and blocks were used with the size and order of the blocks also random.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous falls rates and attrition rates during a similar falls prevention trial, the proportions of the control group and intervention group who would fall during a 1-year period were predicted to be 52% and 32% respectively. To detect this as statistically significant (alpha50.05, power50.80), 105 participants were required in each group. An attrition rate of 30% over the 12 months was assumed given a sample size of 300 (150 in each of the control and intervention groups).
The rate of falls for all participants in the two groups during the 1-year trial was compared with a negative binomial regression model using STATA 9.1 (Stata Corp., College Station, TX). Where secondary outcome measures were not normally distributed, they were log-transformed or converted to categorical variables for analysis. Linear and ordinal logistic regression models controlling for baseline values were then used to compare changes in secondary outcomes in the two groups at 12-month follow-up.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
4/03/2005
Date of last participant enrolment
Anticipated
Actual
13/10/2005
Date of last data collection
Anticipated
Actual
6/09/2006
Sample size
Target
300
Accrual to date
Final
312
Recruitment outside Australia
Country [1] 131 0
New Zealand
State/province [1] 131 0
Wellington

Funding & Sponsors
Funding source category [1] 194 0
Commercial sector/Industry
Name [1] 194 0
Accident Compensation Corporation of New Zealand
Country [1] 194 0
New Zealand
Funding source category [2] 195 0
University
Name [2] 195 0
University of Otago Research Grant
Country [2] 195 0
New Zealand
Funding source category [3] 196 0
Government body
Name [3] 196 0
Hutt Valley District Health Board
Country [3] 196 0
New Zealand
Funding source category [4] 197 0
Charities/Societies/Foundations
Name [4] 197 0
Wellington Medical Research Foundation
Country [4] 197 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Accident Compensation Corporation of New Zealand
Address
Shamrock House
81-83 Molesworth St
PO Box 242
Wellington
Country
New Zealand
Secondary sponsor category [1] 144 0
University
Name [1] 144 0
University of Otago Research Grant
Address [1] 144 0
PO Box 56
Dunedin, 9054
New Zealand
Country [1] 144 0
New Zealand
Secondary sponsor category [2] 145 0
Government body
Name [2] 145 0
Hutt Valley District Health Board
Address [2] 145 0
Hutt Valley,
Wellington
Country [2] 145 0
New Zealand
Secondary sponsor category [3] 146 0
Charities/Societies/Foundations
Name [3] 146 0
Wellington Medical Research Foundation
Address [3] 146 0
PO Box 51 211
Wellington
New Zealand
Country [3] 146 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 955 0
Wellington Ethics Committee
Ethics committee address [1] 955 0
Ministry of Health
1 - 3 The Terrace
PO Box 5013
Wellington
Ethics committee country [1] 955 0
New Zealand
Date submitted for ethics approval [1] 955 0
Approval date [1] 955 0
01/08/2004
Ethics approval number [1] 955 0
WGT/04/08/064

Summary
Brief summary
This randomised controlled trial aimed to assess the effectiveness of a community-based falls-and-fracture nurse coordinator and multifactorial-intervention in reducing falls in older people. Three hundred and twelve community-living people aged 75 and older who had fallen in the previous year were enrolled in the trial. The intervention included a home-based nurse assessment of falls and fracture risk factors and home hazards, referral to
appropriate community interventions, and a strength and balance exercise program. The control group received usual care and social visits. The primary outcome was rate of falls
over 12 months. Secondary outcomes were muscle strength and balance, falls efficacy, activities of daily living, self-reported physical activity level, and quality of life. The final results showed no significant difference in the outcomes between intervention and control groups.
Trial website
Trial related presentations / publications
ELLEY CR, ROBERTSON MC, GARRETT S, KERSE NM, MCKINLAY E, LAWTON B, MORIARTY H, MOYES SA, CAMPBELL AJ. “Effectiveness of a Falls and Fracture Nurse Coordinator to Reduce Falls: Randomized Controlled Trial of At-risk Older Adults” Journal of the American Geriatrics Society, 56: 1383-1389, 2008
Public notes

Contacts
Principal investigator
Name 35947 0
Dr Carolyn Raina Elley
Address 35947 0
Department of General practice and Primary Health Care,
University of Auckland
Private Bag 92019,
Auckland 1142, New Zealand
Country 35947 0
New Zealand
Phone 35947 0
+64 9 373 7599
Fax 35947 0
Email 35947 0
[email protected]
Contact person for public queries
Name 9267 0
Ms Sue Garrett
Address 9267 0
Department of Primary Health Care and General Practice
Wellington School of Medicine and Health Sciences
PO Box 7343
Wellington South
Country 9267 0
New Zealand
Phone 9267 0
+64 4 3855995 ext 6908
Fax 9267 0
+64 4 3855539
Email 9267 0
[email protected]
Contact person for scientific queries
Name 195 0
Dr Carolyn Raina Elley
Address 195 0
Department of General Practice and Primary Health Care, University of Auckland, Private Bag 92019, Auckland
Country 195 0
New Zealand
Phone 195 0
+64 9 3737599
Fax 195 0
nil
Email 195 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
The data are available but we do not have the personnel to answer data requests now


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes ELLEY CR, ROBERTSON MC, GARRETT S, KERSE NM, MCKIN... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMultifactorial and multiple component interventions for preventing falls in older people living in the community.2018https://dx.doi.org/10.1002/14651858.CD012221.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.