Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001190594
Ethics application status
Approved
Date submitted
2/11/2015
Date registered
4/11/2015
Date last updated
16/12/2020
Date data sharing statement initially provided
12/08/2019
Date results information initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a physical activity promotion and fall prevention plan on physical activity and falls in community-dwelling people aged 60+.
Scientific title
What is the effect of a physical activity promotion and fall prevention intervention compared to a nutrition intervention on physical activity participation and falls in community-dwelling people aged 60 years and over?
Secondary ID [1] 287547 0
Nil
Universal Trial Number (UTN)
Trial acronym
CHAnGE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls

 296322 0
Physical activity participation 296324 0
Condition category
Condition code
Injuries and Accidents 296598 296598 0 0
Other injuries and accidents
Public Health 296599 296599 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Participants allocated to the physical activity and fall prevention intervention arm:
1. Will receive a printed booklet about physical activity and fall prevention for healthy ageing.
2. Will undergo an initial two-hour physiotherapy session (at home), in which:
a) A fall risk assessment will be conducted by a research physiotherapist. This will take approximately 10 minutes to complete and will include assessment of key fall risk factors such as balance, mobility, vision, medication use and sensation.
b) A fall prevention and physical activity plan will be jointly developed by the participant and the research therapist using a motivational interviewing approach. This will involve goal setting and developing strategies to maximise motivation and maintenance of increased physical activity and strategies to prevent falls.
c) A pedometer-based activity monitor and feedback device will be provided to all participants by the research therapist who will also demonstrate its use. Participants will be able to choose a device which is able to connect to the internet (e.g. Fitbit activity tracker) or a simple pedometer that does not connect to the internet.
3. Participants will receive access to individual, telephone-based health coaching provided by the research physiotherapist. Each health coaching session will last for approximately 30 minutes and will focus on strategies for increasing physical activity and preventing falls, through behaviour modification and goal setting. Participants will be encouraged to access the service approximately once a fortnight for the first 6 months and then on a monthly basis for the remaining 6 months of the study, so the intervention period is one year in total. Access to this service will cease at the conclusion of the study.
Adherence to the intervention will be monitored through records kept regarding the number of health coaching sessions completed and the number of steps taken as recorded by the internet-based activity tracker or by the steps recorded on a paper-based pedometer diary.
Intervention code [1] 292948 0
Treatment: Other
Intervention code [2] 292949 0
Behaviour
Intervention code [3] 292950 0
Prevention
Comparator / control treatment
Arm 2: A nutrition intervention aiming to encourage healthy eating. It involves the provision of a printed booklet containing information about healthy eating based on the Australian Dietary Guidelines and access to the NSW Ministry of Health 'Get Healthy' telephone-based health coaching service. Participants will be encouraged to access the service approximately once a fortnight for the first 6 months and then on a monthly basis for the remaining 6 months of the study. During this time participants will have the chance to set healthy eating goals and discuss strategies for achieving those goals with the health coach who is a qualified health professional. Each health coaching telephone call will last approximately 30-60 minutes as deemed required by the health professional. Access to this service will cease at the conclusion of the study. Adherence to the intervention will be monitored through records kept by the 'Get Healthy' service regarding the number of health coaching sessions completed
Control group
Active

Outcomes
Primary outcome [1] 296213 0
Primary outcome 1: Physical activity participation assessed as counts/minute over a 7-day period using the Actigraph accelerometer.
Timepoint [1] 296213 0
Timepoint: 12 months after randomisation
Primary outcome [2] 296214 0
Primary Outcome 2: Number of falls in the 12 months after randomisation measured with 12 monthly postal fall calendars
Timepoint [2] 296214 0
Timepoint: 12 months after randomisation
Secondary outcome [1] 317839 0
Secondary Outcome 1: The proportion of fallers in the twelve months after randomisation measured with 12 month falls calendars
Timepoint [1] 317839 0
Timepoint: 12 months after randomisation
Secondary outcome [2] 317840 0
Secondary Outcome 2: The proportion of Actigraph wear time in sedentary, light, moderate and vigorous physical activity
Timepoint [2] 317840 0
Timepoint:6 months and 12 months after randomisation
Secondary outcome [3] 317841 0
Secondary Outcome 3: Body Mass Index measured by self-report
Timepoint [3] 317841 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [4] 317842 0
Secondary Outcome 4: Goal attainment using The Goal Attainment Scale

Timepoint [4] 317842 0
Timepoint: 6 and 12 months after randomisation
Secondary outcome [5] 317843 0
Secondary Outcome 5: Mobility-related confidence assessed using the Modified Gait Efficacy Scale
Timepoint [5] 317843 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [6] 317844 0
Secondary Outcome 6: Quality of life, will be assessed using the EQ-5D-5L
Timepoint [6] 317844 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [7] 317845 0
Secondary Outcome 7: Fear of falling measured using the 7 item Falls Efficacy Scale International
Timepoint [7] 317845 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [8] 317846 0
Secondary Outcome 8: Risk-taking behavior assessed using a 5-item self-report tool
Timepoint [8] 317846 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [9] 317847 0
Secondary Outcome 9: Wellbeing assessed with the 26-item COMPAS-W scale of wellbeing
Timepoint [9] 317847 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [10] 317848 0
Secondary Outcome 10: Mood assessed with the Positive and Negative Affect Schedule
Timepoint [10] 317848 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [11] 317849 0
Secondary Outcome 11: Physical activity assessed with the self-reported Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [11] 317849 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [12] 317850 0
Secondary Outcome 12: Disability assessed using the World Health Organization Disability Assessment Schedule II (WHODAS II)

Timepoint [12] 317850 0
Timepoint: 3, 6 and 12 months after randomisation
Secondary outcome [13] 318361 0
Eating habits assessed with questions from the Australian Health Survey
Timepoint [13] 318361 0
3, 6 and 12 months after randomisation

Eligibility
Key inclusion criteria
Eligible participants will:
Be aged 60 years and over;
Live in a private dwelling or retirement village and;
Regularly (at least once every two months) attend meetings or social events at the participating established community-based group
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be excluded if they:
a) are already meeting the Australian Physical Activity Guidelines for older adults (operationalised as 30 minutes of moderate intensity physical activity five days a week assessed using the Incidental and Planned Exercise Questionnaire and have had a falls risk assessment and intervention program in the past year
b) have a cognitive impairment (a diagnosis of dementia or a Memory Impairment Screen score of less than 5)
c) have insufficient English language skills to fully participate in the program
d) are unable to leave the house without physical assistance from another person or
e) have a progressive neurological disease; or a medical condition precluding exercise


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)
Participating groups will be randomised to either the physical activity/fall prevention intervention or to the nutrition intervention by an independent randomisation service to ensure concealed allocation. Randomisation will occur after all participants in the group have completed all baseline measures to avoid recruitment bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-based minimisation method will be used. Stratification will be by rurality and socioeconomic status of the groups and whether the group purpose is related to physical activity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A total of 30 clusters per group with 10 individuals in each cluster (i.e. 600 participants) will provide 90% power to detect a 10% between-group difference in the primary physical activity outcome. This calculation was undertaken in Stata 13 using the cluster sampsi command and assumed a between-group difference of 23 mean counts/min during wear time, standard deviation of 120, dropout rate of 20%, alpha of 5%, 0.6 correlation between baseline and final measures, and an intra-cluster correlation (ICC) of 0.01. The estimates of mean accelerometer counts per minute were taken from a large sample of accelerometer data. The 60 clusters will provide 80% power to detect as significant, at the 5% level, a 30% lower rate of falls in intervention group participants than control participants (IRR = 0.70) i.e. the primary falls outcome. For this calculation we used the user-written simulation-based nbpower command in Stata 13 and coefficients from previous studies: alpha (over-dispersion in the negative binomial regression model) was assumed to be 0.65 based on a previous trial. We assumed: a control group rate of falls of 0.06 per person month over the follow-up period as this was the rate in a study of a similar population; a design effect of 1.09 with an ICC of 0.01; and withdrawal of 6 clusters. An average follow-up period of 11 months was used to account for loss to follow-up. This sample size is also expected to be sufficient to detect between-group differences in the order of 10-15% for the eating habits outcome and the secondary outcome measures.
Intervention effects will be assessed by means of generalised estimating equations (GEE) models using an exchangeable correlation structure to account for correlation between individuals within the clusters. The number of falls per person-year will be analysed using negative binomial regression models to estimate the difference in rates between the groups after one year (primary outcome). For the continuously-scored primary and secondary outcome measures, Gaussian GEE regression adjusted with their corresponding baseline scores will be used to assess the effect of group allocation. Log-binomial GEE regression, or a robust Poisson regression in case of convergency issues will be used to compare groups on dichotomous outcome measures (proportion of fallers, proportion meeting physical activity cut-points). Planned sub-group analyses will assess differential effects of the intervention by baseline physical activity levels and history of falls. Secondary analyses using causal modelling will be conducted to establish intervention effects in people with greater adherence. Analyses will be conducted using the Stata 13 software package. All analyses will be pre-planned, conducted while masked to group allocation and will use an intention-to-treat approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2015
Actual
20/11/2015
Date of last participant enrolment
Anticipated
Actual
23/08/2018
Date of last data collection
Anticipated
30/09/2019
Actual
30/09/2019
Sample size
Target
600
Accrual to date
Final
606
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 292116 0
Government body
Name [1] 292116 0
NHMRC Project Grant APP1083495
Country [1] 292116 0
Australia
Primary sponsor type
University
Name
The George Institute for Global Health, Sydney Medical School, The University of Sydney
Address
GPO Box 5389
Sydney
NSW 2001 Australia
Country
Australia
Secondary sponsor category [1] 290933 0
None
Name [1] 290933 0
Address [1] 290933 0
Country [1] 290933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293599 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 293599 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 293599 0
Australia
Date submitted for ethics approval [1] 293599 0
Approval date [1] 293599 0
01/09/2015
Ethics approval number [1] 293599 0

Summary
Brief summary
We will conduct a cluster randomised trial (60 groups of older people) to evaluate two healthy ageing strategies among community-dwelling people who attend established community-based groups. The primary objective is to measure the effectiveness of:
a) a physical activity and fall prevention intervention including telephone-based health coaching and written information on physical activity and falls over a 12 month period, and
b) a nutrition intervention including telephone-based health coaching and written information on eating habits over 12 months.
The trial also aims to establish the impact of the interventions on physical activity guideline adherence, eating habits, body mass index, goal attainment, mobility confidence, quality of life, fear of falling, risk taking behaviour, wellbeing and mood.
Trial website
Trial related presentations / publications
TIEDEMANN A, Rissel C, Howard K, Tong A, Merom D, Smith S, Wickham J, Bauman A, Lord SR, Vogler C, Lindley RI, Simpson JM, Allman-Farinelli M, Sherrington C. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial. BMJ Open 2016; 6 (5): e012277
Public notes

Contacts
Principal investigator
Name 60622 0
Prof Catherine Sherrington
Address 60622 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 60622 0
Australia
Phone 60622 0
+61 2 8627 6265
Fax 60622 0
+61296570301
Email 60622 0
cathie.sherrington@sydney.edu.au
Contact person for public queries
Name 60623 0
A/Prof Anne Tiedemmann
Address 60623 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 60623 0
Australia
Phone 60623 0
+61 2 86276233
Fax 60623 0
+61296570301
Email 60623 0
anne.tiedemann@sydney.edu.au
Contact person for scientific queries
Name 60624 0
A/Prof Anne Tiedemann
Address 60624 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd NSW 2050
Country 60624 0
Australia
Phone 60624 0
+61 2 86276233
Fax 60624 0
+61296570301
Email 60624 0
anne.tiedemann@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying main results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following publication of main results
Available to whom?
On a case by case basis at the discretion of the Principal Chief Investigator
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Access subject to approval from Principal Chief Investigator (cathie.sherrington@sydney.edu.au)


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolTiedemann A, Rissel C, Howard K, Tong A, Merom D, Smith S, Wickham J, Bauman A, Lord SR, Vogler C, Lindley RI, Simpson JM, Allman-Farinelli M, Sherrington C. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial. BMJ Open 2016; 6(5): e012277.  
Statistical analysis plan  cathie.sherrington@sydney.edu.au
Informed consent form  cathie.sherrington@sydney.edu.au
Ethical approval  cathie.sherrington@sydney.edu.au


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealth coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: Study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial.2016https://dx.doi.org/10.1136/bmjopen-2016-012277
N.B. These documents automatically identified may not have been verified by the study sponsor.