Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001723279
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
18/10/2018
Date last updated
3/05/2021
Date data sharing statement initially provided
3/05/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Connections Matter: The Role of Social Networks in Community Aged Care
Scientific title
The Role of Social Networks in Cognitive Performance and Wellbeing in Older Adults Receiving Community Aged Care Services
Secondary ID [1] 296346 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 310061 0
Memory performance 310063 0
Condition category
Condition code
Neurological 308819 308819 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Community-dwelling older adults aged 55 years and older receiving aged care services will be invited to undertake an assessment interview on their quality of life, memory performance and social network structures at two time points (baseline and a six month follow-up). Qualified researchers (e.g., with postgraduate degrees in psychology or a similar allied health health background) will conduct these assessments. The interview will take approximately 45 minutes. Their service data (including information on what type of service they received, how long they received it for) will also be collected during this six month period.
Intervention code [1] 312671 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307793 0
Memory performance status as assessed by the Telephone Interview for Cognitive Status-Modified (TICS-M). There are two possible outcomes.: possible memory impairment and no memory impairment.
Timepoint [1] 307793 0
Time 2 (6 month follow-up)
Secondary outcome [1] 352933 0
Social network as assessed by the Lubben Social Network Scale - 12 item (LSNS).
Timepoint [1] 352933 0
Time 2 (6 month follow-up)
Secondary outcome [2] 352934 0
Quality of life as assessed by the European Quality of Life Scale (EQ-5D).
Timepoint [2] 352934 0
Time 2 (6 month follow-up)
Secondary outcome [3] 352995 0
Service use - this will be obtained as recorded information on the client management system. This will include the types of services (e.g., Domestic Assistance, Social Support), the frequency and the length of the service used by the client over the period of 6 months.
Timepoint [3] 352995 0
T1, T2

Eligibility
Key inclusion criteria
Community aged care clients:
1. Receiving community aged care services from a provider in New South Wales
2. Living within NSW
3. No diagnosis of significant brain trauma, stroke or epilepsy.
4. Ability to communicate sufficiently in English (or with the assistance of a translator)
5. Able to provide informed written consent
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Community aged care clients:
1. Not receiving community aged care services from a provider in New South Wales
2. Not living within NSW
3. Diagnosis of significant brain trauma, stroke or epilepsy.
4. Inability to communicate sufficiently in English (or with the assistance of a translator)
5. Unable to provide informed written consent

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A prospective analysis of linked, non-identified records of community aged care clients who are administered the assessments will be performed to quantitatively examine the associations between service provision, social networks and client outcomes (e.g., quality of life and memory function). Descriptive analyses will be used to quantify: i) the types, breadth and level of social networks, memory function and quality of life of clients at baseline; ii) changes in clients’ networks, memory and quality of life at six month follow-up; and iii) community service utilisation captured by the aged care provider’s client management system following assessment. Correlation and regression analyses will be used to determine associations between: i) social networks and quality of life; ii) social networks and community service utilisation; and iii) social networks and memory performance. Potential confounders, such as age and mobility, will be controlled for in these analyses.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
22/10/2018
Actual
18/09/2018
Date of last participant enrolment
Anticipated
Actual
7/03/2019
Date of last data collection
Anticipated
1/07/2019
Actual
12/09/2019
Sample size
Target
500
Accrual to date
Final
177
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300948 0
Charities/Societies/Foundations
Name [1] 300948 0
Dementia Australia Research Foundation
Country [1] 300948 0
Australia
Primary sponsor type
Hospital
Name
Macquarie University
Address
75 Talavera Rd, Macquarie University, NSW, 2109
Country
Australia
Secondary sponsor category [1] 300520 0
None
Name [1] 300520 0
Address [1] 300520 0
Country [1] 300520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301715 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 301715 0
Ethics committee country [1] 301715 0
Australia
Date submitted for ethics approval [1] 301715 0
07/08/2018
Approval date [1] 301715 0
27/08/2018
Ethics approval number [1] 301715 0
5201831394062

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

Contacts
Principal investigator
Name 87862 0
Dr Joyce Siette
Address 87862 0
Level 6, 75 Talavera Rd, Macquarie University, NSW, 2109
Country 87862 0
Australia
Phone 87862 0
+61 0298502456
Fax 87862 0
Email 87862 0
[email protected]
Contact person for public queries
Name 87863 0
Joyce Siette
Address 87863 0
Level 6, 75 Talavera Rd, Macquarie University, NSW, 2109
Country 87863 0
Australia
Phone 87863 0
+61 0298502456
Fax 87863 0
Email 87863 0
[email protected]
Contact person for scientific queries
Name 87864 0
Joyce Siette
Address 87864 0
Level 6, 75 Talavera Rd, Macquarie University, NSW, 2109
Country 87864 0
Australia
Phone 87864 0
+61 0298502456
Fax 87864 0
Email 87864 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
Participant data is de-identified but it is potentially also re-identifiable.
Also, participants did not agree to the sharing of their individual participant data at the time of providing informed consent to participate in the study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11553Study protocolSiette J, Georgiou A, Westbrook J. Observational cohort study investigating cognitive outcomes, social networks and well-being in older adults: a study protocol. BMJ Open 2019;9(6):e029495. doi: 10.1136/bmjopen-2019-029495https://bmjopen.bmj.com/content/9/6/e029495 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseObservational cohort study investigating cognitive outcomes, social networks and well-being in older adults: A study protocol.2019https://dx.doi.org/10.1136/bmjopen-2019-029495
N.B. These documents automatically identified may not have been verified by the study sponsor.