Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001594314p
Ethics application status
Not yet submitted
Date submitted
14/11/2017
Date registered
1/12/2017
Date last updated
1/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Caring for carers of people with dementia: Providing social support to isolated rural carers.
Scientific title
Caring for carers of people with dementia: impact of videoconference groups on self-efficacy, mental health and quality of life for isolated rural carers.
Secondary ID [1] 293353 0
4-4Z3E2G0
Universal Trial Number (UTN)
U1111-1205-0435
Trial acronym
CCPWD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social isolation 305460 0
carer burden 305461 0
psychological distress 305464 0
loneliness 305465 0
Condition category
Condition code
Mental Health 304728 304728 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The core activity of the intervention is a series of 6 x one-hour interactive videoconference (VC) sessions with carers of people living with dementia, one per week for 6 weeks, facilitated by an experienced VC facilitator, with over 20 years’ experience working in the community. Up to 6 participants, per series of 6 sessions, will be connected by VC, to develop a virtual support group. Carers will participate from their own homes. An information sharing approach will be used to facilitate social interaction.
The materials for the interactive sessions will be developed using a co-design approach, whereby, prior to the main intervention, one group of 6 volunteers who care for people living with dementia will share their stories and perceptions about how to connect isolated rural carers. The materials will also draw on the currently available resources (such as those from Dementia Australia and Carers Australia).
The program facilitator will maintain regular contact with participants in the VC sessions, which will support engagement. If people drop out of the program, they will be followed up by phone to ascertain the reason, and to encourage reengagement. Attendance at group sessions, and content delivered, will be monitored by the group facilitator and by the VC software, and all sessions will be recorded, to allow measurement of the fidelity of the intervention.
A focus of the project is the use ubiquitous off-the-shelf technology rather than specialised solutions currently popular in this research area. Tablet or desktop computers will be the VC human interaction interface, coupled with commercial VC software, such as Zoom. Zoom provides group VC with quality that can adapt to different Internet connections (NBN vs ADSL vs 4G); which is very important in rural and regional locations. Particular IT issues will be simplifying use of the VC software, automating data collection, and providing remote support to participants.
Intervention code [1] 299609 0
Other interventions
Comparator / control treatment
A Wait List control will be used. Given the vulnerable population it is not ethical to deny intervention to any participants. A 15 week cycle will be used: 1 week baseline assessment, 6 weeks active intervention/waitlist, week 8 mid assessment, 6 weeks post intervention/active intervention, and week 15 post-test; repeated over 4 cycles,
Control group
Active

Outcomes
Primary outcome [1] 303938 0
Self-efficacy, measured using the short form of the Generalized Self-Efficacy scale (Rompell, et al, 2013)
Timepoint [1] 303938 0
Week 1, Week 8 and Week 15 of each program cycle
Primary outcome [2] 303939 0
Quality of life measured using the Short Form 12 Health Outcomes Scale (SF-12®) (Ware, et al, 1996)
Timepoint [2] 303939 0
Week 1, Week 8 and Week 15 of each program cycle
Primary outcome [3] 303940 0
Psychological distress measured using the Kessler Psychological Distress Scale (K10) (Kessler, et al., 2013)
Timepoint [3] 303940 0
Week 1, Week 8 and Week 15 of each program cycle
Secondary outcome [1] 340517 0
Social networks will be measured using the social network analysis tool for Egocentric mapping (Fiori, et al., 2006)
Timepoint [1] 340517 0
Week 1, Week 8 for Treatment; Week 8, Week 15 for controls
Secondary outcome [2] 340518 0
User beliefs about the acceptability of telehealth will be measured with the Service User Technology Acceptability Questionnaire (SUTAQ) (Hirani, et al., 2016)
Timepoint [2] 340518 0
Week 8 for Treatment and Week 15 for Control
Secondary outcome [3] 340519 0
Health literacy, measured with the Health Literacy Questionnaire (HLQ) (Osborne, et al., 2013)
Timepoint [3] 340519 0
Week 1, Week 8 for Treatment; Week 8, Week 15 for controls
Secondary outcome [4] 340751 0
Intention to continue videoconference interaction, using one item in an on-line survey: "Do you intend to continue meeting in the group by videoconference?"
Timepoint [4] 340751 0
Week 8 for Treatment and Week 15 for Control

Eligibility
Key inclusion criteria
Participants will be carers of older people with dementia residing in geographically isolated areas of Queensland, Australia with access to connection to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18 years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be aggregated by region, and allocated individually to either program or wait list, using computer-generated random numbers, kept at the project management centre. The Principal Investigator will generate the sequence and the Program Manager will enrol participants, and assign them to groups (program or wait list).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
All participants will receive the intervention, with one group allocated to treatment, and the other to wait list control. Allocation to group will be randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
T-tests and ANOVAs will be used to measure differences in outcomes baseline to midpoint to post-test. Factors associated with differences in outcomes will be described using multivariate analyses. Multiple imputation methods will be used in the case of missing data. Intention to treat sensitivity analyses will be undertaken to gauge the effect of drop outs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2018
Actual
Date of last participant enrolment
Anticipated
4/02/2019
Actual
Date of last data collection
Anticipated
1/05/2019
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18089 0
4701 - Rockhampton
Recruitment postcode(s) [2] 18090 0
4870 - Cairns
Recruitment postcode(s) [3] 18091 0
4650 - Maryborough
Recruitment postcode(s) [4] 18092 0
4670 - Bundaberg
Recruitment postcode(s) [5] 18093 0
4655 - Hervey Bay

Funding & Sponsors
Funding source category [1] 297978 0
Government body
Name [1] 297978 0
Australian Department of Health, Dementia and Aged Care Services Fund: Research and Innovation Grants
Country [1] 297978 0
Australia
Primary sponsor type
Individual
Name
Professor Lynne Parkinson
Address
Central Queensland University
Bruce Highway
Rockhampton
Queensland
4701
Country
Australia
Secondary sponsor category [1] 297046 0
None
Name [1] 297046 0
NA
Address [1] 297046 0
NA
Country [1] 297046 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299019 0
CQUniversity's Human Research Ethics Commitee
Ethics committee address [1] 299019 0
Ethics committee country [1] 299019 0
Australia
Date submitted for ethics approval [1] 299019 0
01/12/2017
Approval date [1] 299019 0
Ethics approval number [1] 299019 0

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

Contacts
Principal investigator
Name 79006 0
Prof Lynne Parkinson
Address 79006 0
Central Queensland University
Bruce Highway
Rockhampton 4701
Queensland
Country 79006 0
Australia
Phone 79006 0
+61 410 574005
Fax 79006 0
Email 79006 0
[email protected]
Contact person for public queries
Name 79007 0
Atosha Clancy
Address 79007 0
Central Queensland University
Bruce Highway
Rockhampton 4701
Queensland
Country 79007 0
Australia
Phone 79007 0
+61 409 103 365
Fax 79007 0
Email 79007 0
[email protected]
Contact person for scientific queries
Name 79008 0
Lynne Parkinson
Address 79008 0
Central Queensland University
Bruce Highway
Rockhampton 4701
Queensland
Country 79008 0
Australia
Phone 79008 0
+61 410 574005
Fax 79008 0
Email 79008 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.