Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001679875
Ethics application status
Approved
Date submitted
10/09/2021
Date registered
8/12/2021
Date last updated
13/12/2022
Date data sharing statement initially provided
8/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ageing Well through Eating, Sleeping, Socialising and Mobility (AWESSoM): The effect of a phone app on activities of daily living.
Scientific title
Ageing Well through Eating, Sleeping, Socialising and Mobility (AWESSoM): The effect of the LifeCurve app on functional decline in older community dwellers
Secondary ID [1] 305242 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Decline in activities of daily living (healthy volunteers) 323521 0
Condition category
Condition code
Public Health 321078 321078 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LifeCurve™ app uses a hierarchy of age-related decline in personal activities of daily living (ADL) based on a compression of functional decline model to measure ADL capability and to support behavourial change strategies to enhance function. The app has been adapted through co-design with community groups including Maori and Pacific and trialled by older people for input. The app provides a respository of exercises and advice relevant to the level of ADL as well as local and national services to enhance engagement. App usage is up to the discretion of the individual, and although it will be monitored throughout the trial there are no specific strategies to enhance adherence. A subgroup of participants will be interviewed at the end of the trial to give their views about the app. Access to the app is continuous beyond the trial and is not limited in any way.

The study takes place at two regional centres in NZ, Tauranga (Bay of Plenty) and Howick (Auckland). The app is currently being rolled out through local hospital and health services at Tauranga.

A trained research assistant (RA) interviews participants at home or other site at the beginning of the study with a follow-up interview at 6 months. The RA will ask questions about medical history, nutrition, oral and sleep health and socialisation. Performance based tests of mobility and balance will be carried out. Cognition will be assessed. 7 day accelerometry will measure physical activity, sedentary behaviour and gait. The RA assists the participant to set up the app and explains how to use it. Participants give permission and follow prompts to create a baseline LifeCurve status. They then set tasks, read helpful tips, and follow prompts to local services. A social connector trained by, and contracted to, Age Concern NZ (a national charity), will assist participants who identify social isolation as an issue. The social connector will meet in person to organise referrals to social community groups, agencies and services, and will provide follow-up as required over the 6 month intervention.
Intervention code [1] 321634 0
Treatment: Other
Intervention code [2] 321635 0
Treatment: Devices
Intervention code [3] 321636 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328860 0
Nottingham Activities of Daily Living Scale
Timepoint [1] 328860 0
The primary (and single) timepoint is 6 months after baseline assessment.
Secondary outcome [1] 400659 0
Physical activity from 7 day accelerometry data.
Timepoint [1] 400659 0
6 months after baseline assessment
Secondary outcome [2] 400660 0
6 months after baseline assessment
Timepoint [2] 400660 0
6 months after baseline assessment
Secondary outcome [3] 400661 0
6 months after baseline assessment
Timepoint [3] 400661 0
6 months after baseline assessment
Secondary outcome [4] 400662 0
6 months after baseline assessment
Timepoint [4] 400662 0
6 months after baseline assessment
Secondary outcome [5] 400663 0
6 months after baseline assessment
Timepoint [5] 400663 0
6 months after baseline assessment
Secondary outcome [6] 401672 0
6 months after baseline assessment
Timepoint [6] 401672 0
6 months after baseline assessment
Secondary outcome [7] 402893 0
6 months after baseline assessment
Timepoint [7] 402893 0
6 months after baseline assessment
Secondary outcome [8] 402894 0
6 months after baseline assessment
Timepoint [8] 402894 0
6 months after baseline assessment
Secondary outcome [9] 402895 0
6 months after baseline assessment
Timepoint [9] 402895 0
6 months after baseline assessment
Secondary outcome [10] 402896 0
6 months after baseline assessment
Timepoint [10] 402896 0
6 months after baseline assessment
Secondary outcome [11] 402897 0
6 months after baseline assessment
Timepoint [11] 402897 0
6 months after baseline assessment
Secondary outcome [12] 402898 0
6 months after baseline assessment
Timepoint [12] 402898 0
6 months after baseline assessment
Secondary outcome [13] 402899 0
6 months after baseline assessment
Timepoint [13] 402899 0
6 months after baseline assessment
Secondary outcome [14] 402900 0
6 months after baseline assessment
Timepoint [14] 402900 0
6 months after baseline assessment
Secondary outcome [15] 402901 0
6 months after baseline assessment
Timepoint [15] 402901 0
6 months after baseline assessment
Secondary outcome [16] 402902 0
6 months after baseline assessment
Timepoint [16] 402902 0
6 months after baseline assessment

Eligibility
Key inclusion criteria
Community living adult aged 75 and older (60 and older for Maori and Pacific) with early signs of functional decline identified on the LifeCurve
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Advanced dementia
Lacking capacity to consent
Living in care homes and in palliative care

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 design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive analyses of baseline measures and status on LifeCurve hierarchy of function.
Change in NEADL (primary) and secondary outcomes at 6 months.
Associations between primary and secondary outcomes.
Cohen's effect size to examine change on the LifeCurve at 6 months..
Process evaluation from interview data using principles of reaiist evaluation

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/07/2021
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
54
Final
Recruitment outside Australia
Country [1] 24101 0
New Zealand
State/province [1] 24101 0

Funding & Sponsors
Funding source category [1] 309615 0
Government body
Name [1] 309615 0
Ministry of Business, Innovation and Employment
Country [1] 309615 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
34 Princess St, Auckland CBD, Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 310630 0
University
Name [1] 310630 0
Auckland University of Technology
Address [1] 310630 0
90 Akoranga Drive, Northcote, Auckland 0627
Country [1] 310630 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309390 0
Central Health and Disability Commitee
Ethics committee address [1] 309390 0
Ethics committee country [1] 309390 0
New Zealand
Date submitted for ethics approval [1] 309390 0
Approval date [1] 309390 0
21/01/2021
Ethics approval number [1] 309390 0

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

Contacts
Principal investigator
Name 113986 0
Prof Ngaire Kerse
Address 113986 0
Department of General Practice and Primary Health Care
Private Bag 92019
Auckland 1142
Country 113986 0
New Zealand
Phone 113986 0
+64 99234467
Fax 113986 0
+64 93737624
Email 113986 0
[email protected]
Contact person for public queries
Name 113987 0
Ngaire Kerse
Address 113987 0
Department of General Practice and Primary Health Care
Private Bag 92019
Auckland 1142
Country 113987 0
New Zealand
Phone 113987 0
+64 99234467
Fax 113987 0
+64 93737624
Email 113987 0
[email protected]
Contact person for scientific queries
Name 113988 0
Ngaire Kerse
Address 113988 0
Department of General Practice and Primary Health Care
Private Bag 92019
Auckland 1142
Country 113988 0
New Zealand
Phone 113988 0
+64 99234467
Fax 113988 0
+64 93737624
Email 113988 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?
Individual participant data collected during the trial after de-identification will be available upon request if conditions are acceptable. Data sensitivity may be more explicit for some groups, eg Maori and Pasifika.
When will data be available (start and end dates)?
Immediately following publication. No end date.
Available to whom?
Researchers with a sound research proposal or rationale for requiring access to the data.
Available for what types of analyses?
To achieve the aims as stated in the approved proposal.
How or where can data be obtained?
Proposals should be directed to [email protected] To gain access, data requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13128Study protocol  [email protected] Through discussion with the PI, Prof Ngaire Kerse ... [More Details]
13129Ethical approval  [email protected] Through discussion with the PI, Prof Ngaire Kerse



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOptimising function and well-being in older adults: protocol for an integrated research programme in Aotearoa/New Zealand.2022https://dx.doi.org/10.1186/s12877-022-02845-7
N.B. These documents automatically identified may not have been verified by the study sponsor.