Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001212347
Ethics application status
Approved
Date submitted
16/08/2017
Date registered
18/08/2017
Date last updated
23/06/2021
Date data sharing statement initially provided
27/11/2018
Date results provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ageing well: Effect of a social participation and engagement tool on community participation and quality of life among community aged care clients
Scientific title
Ageing well: Effect of a social participation and engagement tool on community participation and quality of life among community aged care clients
Secondary ID [1] 292637 0
Dementia and Aged Care Services Fund (DACS):
Schedule ID: 4-4ZO9T62
Agreement ID: 4-4ZO9T5A
Universal Trial Number (UTN)
U1111-1200-5886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social participation 304371 0
engagement 304431 0
Condition category
Condition code
Public Health 303699 303699 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Australian Community Participation Questionnaire (ACPQ) and the ICEpop CAPability Measure for Older Adults (ICECAP-O) will be implemented by community aged care support workers from one of Australia's largest aged care providers as part of routine assessment with community aged care clients, The assessments will be conducted face-to-face across New South Wales and the Australian Capital Territory. The data collected from these tools, along with other key outcomes will be analysed at baseline and six month follow-up.

Semi-structured interviews and focus groups with clients and community aged care staff will be conducted regarding their experiences of the social participation and quality of life tools.
Intervention code [1] 298872 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303064 0
Type, breath and level of social participation as determined by the Australian Community Participation Questionnaire (ACPQ).
- Type and level of social participation is determined by analysis of each category of social participation in the ACPQ
- Breath of social participation is determined by the total score obtained in the ACPQ
Timepoint [1] 303064 0
Baseline and six-month follow-up post implementation of tool
Primary outcome [2] 303065 0
Level of quality of life as determined by the mean ICEpop CAPability Measure for Older Adults (ICECAP-O) total score.
Timepoint [2] 303065 0
Baseline and six-month follow-up post implementation of tool
Secondary outcome [1] 337807 0
Community aged care client and support staff experiences of the two social engagement and participation tools using semi-structured interviews and focus groups. Interviews will be conducted face-to-face or via telephone, dependent on what is most suitable for each participant. Focus groups will be conducted face-to-face in a group setting.
Timepoint [1] 337807 0
Between baseline and six-month follow-up post implementation of tool
Secondary outcome [2] 337902 0
Service use as assessed by data linkage to community aged care databases
Timepoint [2] 337902 0
Baseline and on a monthly basis from implementation of tools for six months
Secondary outcome [3] 337903 0
Adverse events (e.g. falls, medication errors, injuries) as assessed by data linkage to community aged care databases
Timepoint [3] 337903 0
Baseline and on a monthly basis from implementation of tools for six months
Secondary outcome [4] 337904 0
Hospitalisation as assessed by data linkage to community aged care databases
Timepoint [4] 337904 0
Baseline and on a monthly basis from implementation of tools for six months
Secondary outcome [5] 337905 0
Time to residential aged care as assessed by data linkage to community aged care databases
Timepoint [5] 337905 0
Six-month follow-up post implementation of tool
Secondary outcome [6] 337906 0
Time to death as assessed by data linkage to community aged care databases
Timepoint [6] 337906 0
Six-month follow-up post implementation of tool
Secondary outcome [7] 337907 0
Ability to complete activities of daily living as assessed by data linkage to community aged care databases
Timepoint [7] 337907 0
Baseline and on a monthly basis from implementation of tools for six months

Eligibility
Key inclusion criteria
Community aged care clients:
1. Receiving community aged care services from Uniting
2. Living within one of the NSW or ACT regions recruited for this study
3. Completed the ACPQ and ICECAP-O with a community aged care support staff
Additional criteria for qualitative element of study (interviews and focus groups):
4. Able to provide written consent, or has an appropriate person that can provide proxy consent on their behalf if required, e.g. due to cognitive impairment
5. Ability to communicate sufficiently in English so they are able to participate in an interview or focus group

Community aged care support staff:
1. Staff member with Uniting
2. Aged 18 or older
3. Experience using the ACPQ and ICECAP-O with a range of clients (people with varying levels of independence, care needs, ability to communicate, and cultural and lingual diversity) between baseline and follow-up (six months)
4. Able to provide written consent
5. Ability to communicate sufficiently in English so they are able to participate in an interview or focus group
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Community aged care consumers:
1. Not receiving community aged care services from Uniting, or cease all services during the study period
2. Did not complete the ACPQ and ICECAP-O with a community aged care support staff
Additional criteria for qualitative element of study (interviews and focus groups):
3. Unable or declines to provide written consent themselves or from a proxy

Community aged care support staff:
1. Under the age of 18
2. Has not used the ACPQ and ICECAP-O with a range of consumers (people with varying levels of independence, care needs, ability to communicate, and cultural and lingual diversity)
3. Unable or declines to provide written consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Quantitative data:
The proposed number of clients enrolled in the study is based on evaluating one of the primary quantitative outcome of interest, quality of life (ICECAP-O). A sample size of between 821 and 1,098 consumers is needed to detect a meaningful change in quality of life scores between baseline and six-month follow-up (with 80% power and 90% power, respectively). This sample size estimate assumes a moderate correlation between pre- and post-scores (r=0.5), and a meaningful change in mean ICECAP-O scores of 0.02.

Analysis of linked de-identified records of clients who are administered the social participation and engagement tools will be performed to quantitatively examine the associations between service provision, social participation and consumer outcomes over the six months following tool administration.

Descriptive analyses will be used to quantify: (i) the types, breadth and level of social participation at baseline; (ii) level of quality of life of clients at baseline; (iii) changes in clients’ social participation and quality of life at six months; and (iv) community service utilisation and other client outcomes captured by the client management system over the six months following tool administration.

Correlation and regression analyses will be used to determine associations between: i) social participation and quality of life; ii) social participation and community service utilisation; and iii) social participation and other consumer outcomes (e.g., time to residential aged care). Potential confounders, such as age and mobility, will be controlled for in these analyses .

Qualitative data:
The qualitative data will be analysed using a structured content analysis approach of client and staff experiences. A critical realist approach will be used.

Data collection and analysis will be conducted in NVivo software. One researcher will perform the initial open coding of the data, which will then be reviewed and modified by the research team. Any discrepancies in coding will be discussed and used to modify the list of codes until all researchers agree on code application. The codes will then be sorted into preliminary domains and themes, which will be repeatedly reviewed and refined by all researchers to maximise homogeneity prior to developing an analytic narrative.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2017
Actual
2/11/2017
Date of last participant enrolment
Anticipated
28/02/2019
Actual
31/12/2018
Date of last data collection
Anticipated
1/07/2019
Actual
1/07/2019
Sample size
Target
1200
Accrual to date
Final
1366
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 297266 0
Government body
Name [1] 297266 0
Dementia and Aged Care Services
Country [1] 297266 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Research office
Macquarie University
North Ryde
NSW
2109
Country
Australia
Secondary sponsor category [1] 296239 0
Commercial sector/Industry
Name [1] 296239 0
Uniting
Address [1] 296239 0
Level 4, 222 Pitt Street
Sydney
NSW
1155
Country [1] 296239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298383 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 298383 0
Ethics committee country [1] 298383 0
Australia
Date submitted for ethics approval [1] 298383 0
12/09/2017
Approval date [1] 298383 0
02/11/2017
Ethics approval number [1] 298383 0
5201700912

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

Contacts
Principal investigator
Name 76906 0
Prof Andrew Georgiou
Address 76906 0
Centre for Health Systems and Safety Research
Australian Institute of Health Innovation
Macquarie University
Room L6 36
Level 6, 75 Talavera Road
Macquarie University
NSW
2109
Country 76906 0
Australia
Phone 76906 0
+61 2 9850 2424
Fax 76906 0
+61 2 9850 2499
Email 76906 0
[email protected]
Contact person for public queries
Name 76907 0
Andrew Georgiou
Address 76907 0
Centre for Health Systems and Safety Research
Australian Institute of Health Innovation
Macquarie University
Room L6 36
Level 6, 75 Talavera Road
Macquarie University
NSW
2109
Country 76907 0
Australia
Phone 76907 0
+61 2 9850 2424
Fax 76907 0
+61 2 9850 2499
Email 76907 0
[email protected]
Contact person for scientific queries
Name 76908 0
Andrew Georgiou
Address 76908 0
Centre for Health Systems and Safety Research
Australian Institute of Health Innovation
Macquarie University
Room L6 36
Level 6, 75 Talavera Road
Macquarie University
NSW
2109
Country 76908 0
Australia
Phone 76908 0
+61 2 9850 2424
Fax 76908 0
+61 2 9850 2499
Email 76908 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
conditions of waiver of consent.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12231Study protocolBrett L, Georgiou A, Jorgensen M, Siette J, Scott G, Gow E, Luckett G, Westbrook J (2019). Ageing well: evaluation of social participation and quality of life tools to enhance community aged care (study protocol). BMC Geriatrics. 19:78 (2019) doi:10.1186/s12877-019-1094-2   373462-(Uploaded-26-11-2019-23-34-20)-Study-related document.pdf
12232Clinical 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.