Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000705785
Ethics application status
Approved
Date submitted
13/04/2022
Date registered
17/05/2022
Date last updated
31/08/2023
Date data sharing statement initially provided
17/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Live Well Intervention: Promoting health behavior change in older people living in South Western Sydney
Scientific title
The Live Well Intervention: Promoting health behavior change in older people living in South Western Sydney
Secondary ID [1] 306857 0
None
Universal Trial Number (UTN)
Trial acronym
LWI (Live Well Intervention)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy ageing 325952 0
Condition category
Condition code
Public Health 323258 323258 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Live Well Intervention: Promoting health behavior change in older people living in South Western Sydney.

Improve the health, wellbeing and resilience of older people/patients living in South Western Sydney through the Live Well goal setting intervention in the following six health domains:
- physical activity
- social activity
- healthy eating
- mental activity
- mental wellbeing
- positive thinking

People 65 or over who live in South Western Sydney who are eligible for Older People's Mental Health (OPMH) services or in contact with Primary Healthcare who do not have a formal existing diagnosis of dementia will meet selection criteria and therefore be eligible to participate in this study.

Suitable clinicians (including GPs, practice nurses and OPMH clinicians) will be trained in delivering the Live Well intervention and register for inclusion. Training will be delivered either in person or online via members of the Live Well project team who are senior clinicians working with South Western Sydney OPMH services. Training will be of 1.5 - 2 hours in duration.
Training is didactic using powerpoint and online videos with the ability to interact/ask questions. There is no minimum timeframe between training and implementation of training.
Training participants are required to provide both a registration form and feedback form to be provided access to intervention materials. These forms will be managed by administrative staff working with the project.

People (patients/consumers) who match the selection criteria will be invited to participate in the study. The intervention will be offered individually either face to face or via videolink and can be conducted either at home or in a clinic setting.

Trained clinicians will start a discussion with potential participants about how lifestyle impacts health, wellbeing and resilience. Then they will discuss the Live Well intervention as one way to address lifestyle factors. Potential participants will be given a participant information sheet on the study and consent will be obtained. Participants will be provided written information on the 6 domains of health and wellbeing. They then will choose one domain that they want to make a difference in and are supported to write a SMART goal (Specific, Measurable, Achievable, Realistic, Time-based) with support to anticipate and overcome potential barriers to goal achievement. SMART goals are generated by the participant with support from the clinician, not prescribed by the clinician. Examples of SMART goals: go for a 15 minute walk in the morning 3 times per week for 12 weeks; go to the local coffee shop twice a week with a friend for 12 weeks. The participants will use a Health and Wellness Questionnaire at pre and post intervention to quantitatively measure their health in the six domains. Post intervention measures will be taken at 6 and 12 weeks follow-up. At follow-up, they will also measure how they feel since setting their goal and their satisfaction with the helpfulness of the intervention to achieve their goal. Support will be offered to modify the goal, problem solve further barriers to participation, set a new goal or the person can choose to stop participation in the intervention. All written material and consumer information videos will be translated in 5 languages (Simplified Chinese, Vietnamese, Arabic, Assyrian and Spanish) and available via https://www.swsphn.com.au/live-well-introduction-to-ageing-well
This material includes the poster; information brochure; videos; smart goal; information sheet and consent form; and evaluation sheets. An interpreter can also be used if required for consent. Videos can also be accessed via https://www.youtube.com/watch?v=Cznlj9z6MFY&list=PLaEI06Attd-xYSDz45zEUD9-x-uLxwvpY
Participants will have the choice of whether they watch the videos with the clinician or at home. A sheet with QR code links to the videos will be available for the participant to easily access videos on demand. Videos range in duration from 1 minute 35seconds to 2minutes 40 seconds. There are 8 videos in total, one video for each of the 6 health domains, 1 video introducing the Live Well intervention and benefits of positive Lifestyle changes, and a video specifically outlining Live Well intervention process. The initial consultation is anticipated to take between 30-60 minutes, and subsequent consultations between 20-40 minutes. Follow-up consultations are recommended at 6 and 12 weeks. Additional supports to achieve goals will be discussed at the initial consultation when addressing potential barriers.
Intervention code [1] 323319 0
Lifestyle
Intervention code [2] 323320 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331002 0
Change in Health and Wellbeing Questionnaire (HAWQ) score indicating a change in the participants performance in the areas of physical activity, social activity, healthy eating, mental activity, mental wellbeing and positive thinking. This questionnaire was designed specifically for this study.
Timepoint [1] 331002 0
At baseline, 6 weeks and 12 weeks post initial intervention.
Secondary outcome [1] 408457 0
Goal achievement in one of 6 health domains: physical activity, social activity, healthy eating, mental activity, mental wellbeing and positive thinking.
SMART goals (Specific, Measurable, Achievable, Realistic, Time Based) will be used to determine actions required and level of goal achievement to meet the outcome.
Data will be collected via one to one interview either face to face or via videolink comparing actions to SMART goal set.
Timepoint [1] 408457 0
At 6 weeks and 12 weeks post initial intervention.
Secondary outcome [2] 408698 0
Self-rated wellbeing due to participation towards goal in one of 6 health-related domains: physical activity, social activity, healthy eating, mental activity, mental wellbeing and positive thinking.
This is measured using a 5-point likert scale rating their sense of well-being.
Timepoint [2] 408698 0
At 6 weeks and 12 weeks post initial intervention.
Secondary outcome [3] 408700 0
Satisfaction with intervention in terms of help to achieve the goal is measured by a 5-point likert scale.
Timepoint [3] 408700 0
At 6 weeks and 12 weeks post initial intervention.

Eligibility
Key inclusion criteria
Residents of South Western Sydney.
People aged 65 and over.
Access to OPMH services or Primary Health (GP).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Formal existing diagnosis of dementia.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Considering 80% power, with 95% confidence level (significance at p< 0.05) and effect size 0.75, a sample size of n=50 for a two-tail one-sample t-test will be statistically sufficient for this kind of pilot study [Browne, 1995]. This targeted sample size of 50 participants recruitment is consistent with current literature on qualitative studies (Kuzel, 1999), and of those involving behaviour change (Rabheru et al 2021).
Following the baseline assessment, after completion of the two post-intervention successive follow-up assessments at six-weeks and 12-weeks, statistical analysis will be carried out. In the first step, we will present the descriptive statistics for all measures for three assessment period respectively. In the next step, we will present each outcome measures with 95% Confidence Interval. The differences of main outcome measures between baseline and two follow-up assessments will be examined by paired sample analysis for repeated measures. Based on the two-way comparisons, we will compute effect sizes for each of the outcome as an indication of the magnitude of differences in study outcomes between baseline and post-intervention assessments. The analyses will be performed in SPSS version 27.
[Ref. IBMCorp, IBM SPSS Statistics for Windows, Version 27.0. Armonk, NY: IBM Corp Released 2020.]


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2022
Actual
1/06/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
7/04/2023
Date of last data collection
Anticipated
31/12/2022
Actual
30/06/2023
Sample size
Target
50
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311179 0
Government body
Name [1] 311179 0
South Western Sydney Primary Health Network
Country [1] 311179 0
Australia
Primary sponsor type
Government body
Name
South Western Sydney Local Health District
Address
South Western Sydney Local Health District Executive Office
Locked Bag 7279
LIVERPOOL BC NSW 1871
Country
Australia
Secondary sponsor category [1] 312539 0
None
Name [1] 312539 0
Address [1] 312539 0
Country [1] 312539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310710 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 310710 0
Ethics committee country [1] 310710 0
Australia
Date submitted for ethics approval [1] 310710 0
28/02/2022
Approval date [1] 310710 0
10/05/2022
Ethics approval number [1] 310710 0

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

Contacts
Principal investigator
Name 118598 0
Dr Carmelo Aquilina
Address 118598 0
Mental Health Centre Level 1
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 118598 0
Australia
Phone 118598 0
+61 2 96164243
Fax 118598 0
Email 118598 0
[email protected]
Contact person for public queries
Name 118599 0
Lachlan Best
Address 118599 0
Macarthur Older People’s Mental Health Service
Camden Hospital
PO Box 99
Camden NSW 2570
Country 118599 0
Australia
Phone 118599 0
+61 2 4654 6342
Fax 118599 0
Email 118599 0
[email protected]
Contact person for scientific queries
Name 118600 0
Carmelo Aquilina
Address 118600 0
Mental Health Centre Level 1
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 118600 0
Australia
Phone 118600 0
+61 2 96164243
Fax 118600 0
Email 118600 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?
All individual participant data collected during the trial, after de-identification collated in an excel spreadsheet (.XLS)
When will data be available (start and end dates)?
From time of analysis and publication for a period of 5 years
Available to whom?
Bona fide researchers and clinicians from recognised institutions
Available for what types of analyses?
Unrestricted
How or where can data be obtained?
Please contact [email protected] to request.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15774Study protocol  [email protected]
15775Statistical analysis plan  [email protected]
15776Ethical approval  [email protected]
15777Informed consent form  [email protected]
15778Clinical study report  [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.