Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001662156
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
27/11/2019
Date last updated
4/09/2020
Date data sharing statement initially provided
27/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can dementia education improve stress and quality of life for dementia carers?
Scientific title
Can online dementia education improve stress and quality of life for dementia carers? A randomised controlled trial
Secondary ID [1] 298912 0
None
Universal Trial Number (UTN)
Trial acronym
ReSTEd (Reducing Stress Through Education)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia carers' stress 313890 0
Quality of life
 313891 0
Condition category
Condition code
Public Health 312306 312306 0 0
Health promotion/education
Neurological 312307 312307 0 0
Dementias
Mental Health 312308 312308 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project compares an experimental arm where people complete a 7-week Understanding Dementia Massive Open Online Course (UD MOOC) that is designed to assist dementia carers to understand dementia and its impacts on people living with the condition, with a control arm where people receive links to information on dementia available from the Dementia Australia (DA) website. The information on the DA website can easily be obtained by anyone who seeks information on dementia and unlike the UD MOOC, it does not aim to give carers in-depth understanding of effects of dementia on people living with dementia and ways to help carers cope better with the dementia symptoms.

The UD MOOC is an accessible online educational innovation that was developed in 2013 to serve as a major intervention to boost knowledge and awareness of dementia at a population level. This scalable initiative was designed to address the needs of family carers, aged care workers and health professionals, and, through education, to improve the lives of both people with dementia, and their families. Specifically, the UD MOOC seeks to support families and carers to understand dementia to provide a foundation for care throughout the trajectory of dementia.
The UD MOOC is presently delivered as a 7-week on-line course (recommended 21 hours total engagement including interactive discussion fora) oriented around 3 modules:
• The ‘Brain’ module covers basic human neuroscience, as well as the pathological changes that characterise the major forms of dementia.
• The ‘Diseases’ module describes the diagnosis and major clinical features of dementia, as well as risk factors and medical management.
• The ‘Person’ module examines the progression of dementia, therapeutic approaches, psychosocial interventions, dementia palliation and the support of the person with dementia and carer through this trajectory.
The UD MOOC includes a variety of learning approaches, including video interviews with experts in the field across Australia and internationally, a range of prompted discussion fora, gamified learning and quizzes.
Importantly, the UD MOOC educational framework orients around a total dementia trajectory and whole-person approach to understanding dementia, which has potentially direct psychosocial wellbeing and social inclusion effects. This is supported by accounts of the personal impacts of dementia, as described by people with dementia as well as family carers. The UD MOOC provides an opportunity to equip participants with an understanding of the trajectory of dementia and how this may influence care and, given the support and discussion fora provided to the global community of participants, also assists in building social networks and social capital to support participants. In this regard, the UD MOOC involves active learning, where, by way of participation in discussion fora, in particular, the people in the course construct the learning experience.

Emails will be sent to participants in the experimental arm informing them of the availability of each module and closure of the course as a reminder to complete the modules. Participants’ engagement and progression in the course will be measured by their time-stamped logins to the course and completion of sequential modules.
Intervention code [1] 315192 0
Treatment: Other
Intervention code [2] 315193 0
Lifestyle
Comparator / control treatment
Carers in the control arm will not have access to the UD MOOC initially and will be alerted to publicly available resources for dementia, specifically from Dementia Australia. To match the frequency release of UD MOOC modules, carers will receive links to information on dementia at week 1, 3 and 5 via emails.
Control group
Active

Outcomes
Primary outcome [1] 320943 0
Carers’ stress level will be assessed with self-reported questionnaires. The 12-item Neuropsychiatric Inventory Questionnaire (NPI-Q), which is an informant-based instrument that measures the presence and severity of neuropsychiatric symptoms in people with dementia, as well as informant distress, will be used in this study. An additional item that measures stress due to the affiliate stigma that they experienced is added to the questionnaire. General stress level will also be measured with the stress-related items from the Depression Anxiety Stress Scale (DASS).
Timepoint [1] 320943 0
The questionnaires will be completed at baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [1] 373446 0
The Dementia Literacy Assessment Model will be used to determine carers' dementia literacy, specifically recognising and understanding causes, accessing information, professional care and support, and informed attitudes to dementia.
Timepoint [1] 373446 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [2] 373447 0
The Dementia Knowledge Assessment Scale (Annear et al., 2017) will be used to determine carers' knowledge of dementia to examine how this may mediate the primary outcome.
Timepoint [2] 373447 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [3] 373448 0
Affiliate stigma scale will be used to assess the self-stigma of carers providing care to a family member with dementia.
Timepoint [3] 373448 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [4] 373449 0
Sleep quality for dementia carers will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [4] 373449 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [5] 373450 0
Quality of life for dementia carers will be assessed using the C-DEMQOL. One separate satisfaction with life question will also be used to measure satisfaction with life as a whole.
Timepoint [5] 373450 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [6] 373451 0
UCLA Loneliness scale will be used to assess loneliness.
Timepoint [6] 373451 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [7] 373452 0
Depression Anxiety Stress scale will measure the negative emotional states of depression and anxiety.
Timepoint [7] 373452 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [8] 373453 0
Quality of life for people living with dementia will be assessed by DEM-QOL (proxy) and will be completed by carers.
Timepoint [8] 373453 0
Baseline, 10 and 34 weeks after commencement of the intervention.
Secondary outcome [9] 373454 0
Activities of daily living of people living with dementia will be assessed by Katz Activities of Daily Living scale. KATS ADL assesses six primary and psychosocial functions: bathing, dressing, going to toilet, transferring, feeding and continence.
Timepoint [9] 373454 0
Baseline, 10 and 34 weeks after commencement of the intervention.

Eligibility
Key inclusion criteria
To be eligible for the study, participants are required to be adults carers (aged 18 and older self-identified primary carer living in the same household as the person with dementia they care for). Eligible carers will be familiar with using Internet-based resources in the English language (e.g. we have found that the ability to navigate the MOOC is similar to that used for engagement with social media) and have access to a device suitable for engaging with the UD MOOC or internet based information.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who have completed any formal education (courses) in dementia including prior iterations of the UD MOOC or Prevent Dementia MOOC previously will be excluded from the participation. Potential participants with any neurological conditions as well as blindness or deafness at recruitment will be excluded as they need to be able to read/watch materials on dementia and be able to understand the contents.

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)
Participants who meet all inclusion and no exclusion criteria will be invited for the online baseline assessment. Following the baseline assessment, participants will be randomised into one of two groups using a computer sequence generation by a member of the research team who is not involved in the testing of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial will use a computer-generated randomisation procedure.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using G-Power, the sample size was determined for a repeated-measures ANOVA within-between interaction. Specifying a small effect size f = 0.15, with a = .05 and 1-ß = 0.80, 74 carers (37 in each group) would be required for the experiment to have enough power to reveal a significant group x time interaction. To account for drop-out and adjustment for multiple comparisons, we would seek to recruit 200 participants (100 in each group) over a year to coincide with the planned running of the MOOC.

The design of the experiment is repeated measures spread over two cohorts, so repeated-measures ANOVA and mixed-effects regression models will be used to account for clustering and the non-independence of residuals, with a random intercept for cohort and participant. The fixed effects are experimental groups and time. Statistical adjustments will be made for covariates, for example, education, sex, age and duration of caregiving.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/01/2020
Actual
6/02/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
22/06/2021
Actual
Sample size
Target
200
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303461 0
Charities/Societies/Foundations
Name [1] 303461 0
J.O. & J.R. Wicking Trust
Country [1] 303461 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Ave, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 303514 0
None
Name [1] 303514 0
None
Address [1] 303514 0
None
Country [1] 303514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303992 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 303992 0
Ethics committee country [1] 303992 0
Australia
Date submitted for ethics approval [1] 303992 0
22/07/2019
Approval date [1] 303992 0
04/12/2019
Ethics approval number [1] 303992 0
H0018268

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

Contacts
Principal investigator
Name 95478 0
Dr Kathleen Doherty
Address 95478 0
Wicking Dementia Research & Education Centre
University of Tasmania
Private Bag 143
Hobart TAS 7001
Country 95478 0
Australia
Phone 95478 0
+61 362264752
Fax 95478 0
Email 95478 0
[email protected]
Contact person for public queries
Name 95479 0
Sarang Kim
Address 95479 0
Wicking Dementia Research & Education Centre
University of Tasmania
Private Bag 143
Hobart TAS 7001
Country 95479 0
Australia
Phone 95479 0
+61 362265721
Fax 95479 0
Email 95479 0
[email protected]
Contact person for scientific queries
Name 95480 0
Sarang Kim
Address 95480 0
Wicking Dementia Research & Education Centre
University of Tasmania
Private Bag 143
Hobart TAS 7001
Country 95480 0
Australia
Phone 95480 0
+61 362265721
Fax 95480 0
Email 95480 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
Individual participant data will not be available as indicated in the information sheet given to participants.


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.