Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000509561
Ethics application status
Approved
Date submitted
11/05/2015
Date registered
21/05/2015
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
An online program for carers of people with dementia on management of behavioural and psychological symptoms
Scientific title
In carers of people with dementia, what is the effect of an online program on managing behaviours common in dementia compared with an education website on levels of carer stress related to behavioural and psychological symptoms?
Secondary ID [1] 286654 0
Nil
Secondary ID [2] 288607 0
Nil known
Universal Trial Number (UTN)
U1111-1169-9469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carer Stress and Burden 294986 0
Dementia 294988 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295253 295253 0 0
Occupational therapy
Neurological 295254 295254 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The online program for carers of people with dementia is comprised of an educational fact sheet explaining (i) dementia, (ii) behaviour changes in people with dementia, and (iii) how to plan activities for people with dementia. It also includes 20 animations exploring behaviours common in dementia and 20 associated problem-solving worksheets that allow the participant to apply the videos to their own situation. Carers can access the program as many times as they would like by logging in online over 8 weeks. Adherence is monitored by collecting self-report and user-access data.
Intervention code [1] 291800 0
Behaviour
Comparator / control treatment
The educational website is an Alzheimer’s Australia webpage with help sheets that address the most commonly raised issues about dementia (https://fightdementia.org.au/about-dementia-and-memory-loss/help-sheets)
Control group
Active

Outcomes
Primary outcome [1] 295000 0
Neuropsychiatric Inventory Questionnaire (NPI-Q) self-complete version- carer distress scale
Timepoint [1] 295000 0
Baseline, week 9 (post), week 21 (3 month follow-up)
Secondary outcome [1] 314553 0
Neuropsychiatric Inventory Questionnaire (NPI-Q) self-complete version - total score
Timepoint [1] 314553 0
Baseline, week 9 (post), week 21 (3 month follow-up)
Secondary outcome [2] 314554 0
Zarit Burden Inventory- short version
Timepoint [2] 314554 0
Baseline, during the program, week 9 (post), week 21 (3 month follow-up)
Secondary outcome [3] 314616 0
Kessler-6
Timepoint [3] 314616 0
Baseline, during the program, week 9 (post), week 21 (3 month follow-up)

Eligibility
Key inclusion criteria
*Unpaid/family carer of a person with moderate to severe dementia
*Australian resident
*18 years of age or older
*Fluent in written English
*Access to internet with PDF reader and valid email address
*Willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who do not fulfil inclusion criteria

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 apply online, complete eligibility questionnaires, and if eligible are randomised. Allocation is completed by computer software using randomisation table and therefore concealed from researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A meta-analysis of 23 carer programs for managing symptoms of dementia yielded an effect size of 0.34 (Brodaty & Arasaratnam, 2012). A power analysis was conducted to inform the sample size using a conservative expected effect size difference between the groups of 0.2. It is estimated that we would require 200 participants to reach a significance level of p=0.05, at 80% power (Cohen, 1988).

Analyses will be carried out using SPSS. Descriptive statistics will be computed for demographic questions and the online questionnaires (including internal consistency). Relationships across measures (e.g., bivariate correlations and regression analyses) will be examined. Group by time interactions will be examined using linear mixed models to determine whether the program reduced carer distress and burden, in comparison to the educational website. Content analysis will be undertaken to determine qualitatively how acceptable and useful carers perceived the program to be.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
1/08/2015
Actual
20/01/2016
Date of last data collection
Anticipated
Actual
8/07/2016
Sample size
Target
200
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 3775 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst

Funding & Sponsors
Funding source category [1] 291240 0
University
Name [1] 291240 0
University of New South Wales
Country [1] 291240 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
School of Psychiatry
Faculty of Medicine
Level 3, AGSM Building
UNSW
Sydney, NSW 2052
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 289919 0
Hospital
Name [1] 289919 0
Clinical Research Unit for Anxiety and Depression at St Vincent's Hospital
Address [1] 289919 0
Level 4, The O'Brien Centre
St Vincent's Hospital
394-404 Victoria Street
Darlinghurst NSW 2010
Country [1] 289919 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292800 0
St Vincent's Hospital Sydney
Ethics committee address [1] 292800 0
Ethics committee country [1] 292800 0
Australia
Date submitted for ethics approval [1] 292800 0
06/01/2015
Approval date [1] 292800 0
29/01/2015
Ethics approval number [1] 292800 0
LNR/15/SVH/21

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

Contacts
Principal investigator
Name 57054 0
A/Prof Lee-fay Low
Address 57054 0
C43M - M Block Cumberland Campus
The University of Sydney
Country 57054 0
Australia
Phone 57054 0
+61 2 9036 7368
Fax 57054 0
Email 57054 0
[email protected]
Contact person for public queries
Name 57055 0
Lee-Fay Low
Address 57055 0
C43M - M Block Cumberland Campus
The University of Sydney
Country 57055 0
Australia
Phone 57055 0
+61 2 9036 7368
Fax 57055 0
Email 57055 0
[email protected]
Contact person for scientific queries
Name 57056 0
Lee-Fay Low
Address 57056 0
C43M - M Block Cumberland Campus
The University of Sydney
Country 57056 0
Australia
Phone 57056 0
+61 2 9036 7368
Fax 57056 0
Email 57056 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.