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Trial registered on ANZCTR


Registration number
ACTRN12618001213235
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
19/07/2018
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
VERILY - Virtual Dementia Friendly Rural Communities: Using technology to improve support for carers of people living with dementia in rural communities
Scientific title
Virtual Dementia Friendly Rural (VERILY) Communities: An open cohort stepped wedge cluster randomised controlled trial of a technology-based intervention on social support for carers of people living with dementia in rural communities
Secondary ID [1] 294476 0
None
Universal Trial Number (UTN)
Trial acronym
VERILY project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 307236 0
Support for carers of people living with dementia 308896 0
Condition category
Condition code
Neurological 306353 306353 0 0
Dementias
Public Health 307801 307801 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 components of the intervention which will be all made available to all participants when they are assigned to the intervention group:
1. A “technology learning hub” in each rural community that is staffed by volunteers who have been trained to help carers to learn how to use online technology. The hub is available during business hours for access at participants' discretion.
2. A website and mobile application (app) that provide information about services for people with dementia and that also helps connect carers and service providers with each other. Both the website and app have been specifically designed for the study. However, some of the content has been collated from readily available literature and other information sources which we have cited and acknowledged accordingly. The website and app will be available ad libitum.
3. Carer peer support groups that meet by video-conference once every eight weeks. The groups are not facilitated but will be organised by the study research officer who will also monitor and record session attendance.

Owing to the open cohort stepped wedge design, the intervention duration will be dependent on the time each cluster commences the intervention. Hence the intervention will be delivered over a minimum of 8 weeks and a maximum of 32 weeks.

The research officers will collect data on the usage and access of each of the intervention strategies. We will also use website/app analytics from logins to monitor adherence and access google data analytics on website/app use.
Intervention code [1] 300766 0
Treatment: Other
Comparator / control treatment
In this stepped wedge cluster randomised controlled trial, each cluster will provide its own control data during the pre-intervention period. Each step will be 8 weeks long.
Control group
Active

Outcomes
Primary outcome [1] 305375 0
Change in carer support as measured by Medical Outcomes Study (MOS) Social Support Survey
Timepoint [1] 305375 0
Baseline, at every 8 weeks up to 32 weeks post baseline (primary time point)
Secondary outcome [1] 344984 0
Change in self-reported awareness of dementia services available in the community using a study specific questionnaire.
Timepoint [1] 344984 0
Baseline, 16 and 32 weeks post baseline
Secondary outcome [2] 344987 0
Change in carers use of information and communication technology using a survey adapted from Elliot et. al.. 2014
Timepoint [2] 344987 0
Baseline, 16 and 32 weeks post baseline
Secondary outcome [3] 348597 0
Change in carers burden score as measured by Zarit Burden Interview
Timepoint [3] 348597 0
Baseline, 16 and 32 weeks post baseline
Secondary outcome [4] 349496 0
Composite estimate of costs and benefits of the intervention. Costs of developing the intervention (website and app developer fees and hosting fees) and intervention implementation (staff and resources: volunteer training, research officer time, volunteer and carer time, estimates of internet use time and frequency) will be recorded during the project. The costs will differentiate between actual intervention and study-related costs.
Benefits will be based on the brief Older People's Quality of Life questionnaire (OPQOL-brief) (Bowling et al. 2014)
Timepoint [4] 349496 0
Baseline and 32 weeks post baseline

Eligibility
Key inclusion criteria
Carers:
- caring for a person with dementia or cognitive impairment
- live in the catchment area
- willingness to try the app on a smartphone or tablet with internet access or to use the website on a computer with internet access AND/OR willingness to participate in peer support groups via video-conference on a electronic communication device with internet access and video-conferencing functionality

Community volunteers:
- live in the catchment area
- willingness to undertake volunteer training
- willingness to assist people to learn to use online/digital technologies

Service provider staff:
- provide dementia service or service for older adults in the catchment area
- willingness to try the app on a smartphone or tablet with internet access or to use the website on a computer with internet access


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who do not have functional English language as the VERILY app and website are developed in English.

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 involves contacting an off-site statistician who holds the a computer-generated random allocation sequence allocation schedule. She will be blinded to the identity of the clusters and will not be involved in the delivery of the intervention, participant recruitment or data collection of outcomes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stepped wedge stratified cluster randomisation, with community cluster as a stratification factor.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations:
Our sample size calculation shows that with 15 carers from 12 rural communities at each of the five data collection time points (baseline and four follow-up periods) will have a minimum of 80% power to detect a 9 point difference in mean MOS Social Support Survey score between the intervention and control phases, assuming a standard deviation of 24.2, based on the Australian Longitudinal Study on Women's Health (ALSWH, 2002) and 20% attrition rate over the study period. Therefore we are aiming to recruit a total of n=180 carers.

Power was calculated using a simulation study based on the following assumptions: 12 rural communities with 12 carers from each community that contribute data at each of the 5 data collection periods; a difference in the mean MOS Social Support Survey score of 9 (Nordtug et. al, 2013, ALSWH, 2002) between the intervention and control phases; standard deviation of 24.2 (ALSWH, 2002); alpha of 0.05 for a two-sided test; an intra-community correlation coefficient of 0.01 and 0.05; within-carer correlation (0.3, 0.5, 0.7) for repeat outcome measures on carers.

Two thousand replications were run for each set of parameter combinations. A linear mixed effects model where the intervention and period effects were assumed to be fixed and carer and community effects to be random was used to estimate the intervention effect for each simulation. The study power was calculated as the proportion among all 2000 simulation runs of two-sided p-values for the estimated intervention effect that reached a nominal value of less than 0.05. Two-thousand replications were sufficient to estimate the power with a margin of error of 1.75%, assuming the true power was 80%. (Palmer et al. 2015). Simulations were run in R version 3.5.1 (R Development Core Team, 2018).

Data Analysis
Descriptive statistics will be used to summarise the baseline characteristics of carers when they first entered the open cohort by each arm. A linear mixed effects model will be used to compare the intervention and control phases for continuous outcomes and generalized linear mixed effects model for binary outcomes. Analysis will be intention-to-treat, where carers will be analysed in the group that the rural community was assigned to at each study period. The outcomes for carers collected at each data collection time point will be arranged into a long file, with an indicator variable created for when a carer was in the intervention or control phase, a variable that identifies the period of the study the outcome was collected (baseline, 1=8 weeks to <16 weeks; 2=16 to <24weeks, 3=24weeks to <32weeks, 4=32weeks to <40 weeks) and variables that identify the repeated outcomes measured on the same carer and the cluster that the carer belonged too. Intervention status and study period will be fitted as fixed effects. Study period will be adjusted for in the model because intervention status is time-dependent. The intercept will be constrained to be equal during the control phases because no intervention effect is expected. Rural communities and carers will be treated as random effects to adjust for the within-community and within-carer correlations, respectively. The estimated intervention effect will be reported as mean outcome difference for continuous outcomes and odds ratio for binary outcomes between study periods, with respective 95% confidence intervals and p-values.

Secondary analysis will performed to examine the effects of temporal effects of exposure to the intervention. Other confounders which will be adjusted for include the age of the carers, and duration of caring.

Analysis will be conducted using IBM SPSS Statistics Version 24 (IBM Corp, Armonk, New York).

Analysis of volunteers’ data
Statistical information about volunteer activities will be analysed to produce descriptive statistics and will be included as part of a health economic analysis.

Critical incident reports and deidentified volunteer meeting minutes will be analysed qualitatively to produce a descriptive qualitative analysis, including thematic analysis. The focus groups will be audio-recorded and transcribed verbatim and then qualitatively analysed to produce a content analysis.

Analysis of staff data
Staff interviews will be audio-recorded and transcribed verbatim and then analysed using the Consolidated Framework for Implementation Research (CFIR) to understand the why, what, how, and when of implementation and sustainability (Damschroder et al, 2009).

Analysis of researchers’ observational data and notes from phone calls
These data will be qualitatively analysed to identify and manage issues arising during project implementation and to identify any unintended consequences of VERILY. These data will also assist us to analyse and document any flow on effects of VERILY to the broader community. A descriptive qualitative analysis will be produced.

The cost of delivering the VERILY intervention strategies will be recorded. However no economic evaluation will be undertaken.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
23/07/2018
Actual
9/08/2018
Date of last participant enrolment
Anticipated
8/04/2019
Actual
24/06/2019
Date of last data collection
Anticipated
31/10/2019
Actual
Sample size
Target
180
Accrual to date
Final
113
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 11339 0
Kooweerup Regional Health Service - Koo Wee Rup
Recruitment hospital [2] 11340 0
Heathcote Health - Heathcote
Recruitment hospital [3] 11341 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [4] 11342 0
Edenhope and District Memorial Hospital - Edenhope
Recruitment hospital [5] 11343 0
Rural Northwest Health - Warracknabeal campus - Warracknabeal
Recruitment hospital [6] 11344 0
Robinvale District Health Services - Robinvale campus - Robinvale
Recruitment hospital [7] 11345 0
Mansfield District Hospital - Mansfield
Recruitment hospital [8] 11346 0
South Coast District Hospital - Victor Harbor
Recruitment hospital [9] 11381 0
Cobaw Community Health Service - Kyneton
Recruitment hospital [10] 11400 0
Molong HealthOne General Practice - Molong
Recruitment hospital [11] 11401 0
Nyngan Health Service - Nyngan
Recruitment hospital [12] 11402 0
Riverland General Hospital - Berri
Recruitment postcode(s) [1] 23068 0
5211 - Victor Harbor
Recruitment postcode(s) [2] 23069 0
5341 - Renmark
Recruitment postcode(s) [3] 23070 0
3722 - Mansfield
Recruitment postcode(s) [4] 23071 0
3393 - Warracknabeal
Recruitment postcode(s) [5] 23072 0
3444 - Kyneton
Recruitment postcode(s) [6] 23073 0
3981 - Koo Wee Rup
Recruitment postcode(s) [7] 23074 0
3523 - Heathcote
Recruitment postcode(s) [8] 23075 0
3318 - Edenhope
Recruitment postcode(s) [9] 23076 0
3549 - Robinvale
Recruitment postcode(s) [10] 23245 0
3400 - Horsham
Recruitment postcode(s) [11] 23294 0
2825 - Nyngan
Recruitment postcode(s) [12] 23295 0
2866 - Molong
Recruitment postcode(s) [13] 23301 0
5343 - Berri
Recruitment postcode(s) [14] 23303 0
5333 - Loxton
Recruitment postcode(s) [15] 23304 0
5345 - Barmera
Recruitment postcode(s) [16] 23305 0
5330 - Waikerie

Funding & Sponsors
Funding source category [1] 299100 0
Government body
Name [1] 299100 0
Dementia and Aged Care Services Funds, Commonwealth of Australia Department of Health
Country [1] 299100 0
Australia
Primary sponsor type
University
Name
Professor Irene Blackberry
Address
John Richards Centre for Rural Ageing Research
La Trobe Rural Health School, La Trobe University
133 McKoy Street,
Wodonga, ViC 3689
Country
Australia
Secondary sponsor category [1] 299180 0
None
Name [1] 299180 0
Address [1] 299180 0
Country [1] 299180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300034 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300034 0
Ethics committee country [1] 300034 0
Australia
Date submitted for ethics approval [1] 300034 0
Approval date [1] 300034 0
05/03/2018
Ethics approval number [1] 300034 0
HREC/17/MH/404

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2883 2883 0 0
/AnzctrAttachments/374819(v16-07-2018-12-55-53)-REFERENCES.docx (Supplementary information)

Contacts
Principal investigator
Name 82334 0
Prof Irene Blackberry
Address 82334 0
John Richards Centre for Rural Ageing Research
La Trobe Rural Health School, La Trobe University
133 McKoy Street,
Wodonga, ViC 3689
Country 82334 0
Australia
Phone 82334 0
+61 2 6024 9613
Fax 82334 0
Email 82334 0
i.blackberry@latrobe.edu.au
Contact person for public queries
Name 82335 0
Irene Blackberry
Address 82335 0
John Richards Centre for Rural Ageing Research
La Trobe Rural Health School, La Trobe University
133 McKoy Street,
Wodonga, ViC 3689
Country 82335 0
Australia
Phone 82335 0
+61 2 6024 9613
Fax 82335 0
Email 82335 0
i.blackberry@latrobe.edu.au
Contact person for scientific queries
Name 82336 0
Irene Blackberry
Address 82336 0
John Richards Centre for Rural Ageing Research
La Trobe Rural Health School, La Trobe University
133 McKoy Street,
Wodonga, ViC 3689
Country 82336 0
Australia
Phone 82336 0
+61 2 6024 9613
Fax 82336 0
Email 82336 0
i.blackberry@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The conditions of current ethical approval exclude sharing of IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3233Study protocol    Publication pending
3234Ethical approval    374819-(Uploaded-18-07-2019-12-05-42)-Study-related document.pdf



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.