Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000564651
Ethics application status
Not yet submitted
Date submitted
29/04/2014
Date registered
27/05/2014
Date last updated
27/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth support for carers of people living with vascular and mixed dementia.
Scientific title
A randomized controlled trial of telephone and ipad support on self-efficacy and mood in family carers of people living with vascular or mixed dementia in the community.
Secondary ID [1] 284489 0
NIL
Universal Trial Number (UTN)
U1111-1156-0837
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vascular Dementia 291737 0
Mixed Dementia 291738 0
Condition category
Condition code
Neurological 292106 292106 0 0
Dementias
Stroke 292341 292341 0 0
Ischaemic
Stroke 292342 292342 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 6-month intervention is a multi-component telephone call, a Google+ hangout setup on an ipad or tablet plus health promotion and dementia information on the tablet. Trained nursing and psychology therapists will conduct intervention contacts. The intervention will be tailored to individual carer/participant needs, will be conducted in sessions of up to 30 minutes per session, usually weekly and will be conducted approximately once per week for up to 12-weeks, followed by regular negotiated calls (0-12) for a further three months. Participants will be provided with a Stroke Foundation information pack together with information about risk factors, knowledge of dementia and other educational resources on their ipad/tablet. The intervention will include psycho-education about dementia, counseling for mood disorders in the family carer and emotional support and education about risk factors. Participants will be counseled about health risk behavior including quarterly general practitioner visits, risk factor management and monitoring. Therapists will refer participants to appropriate health professionals where necessary. Therapists will liaise with health professionals, case managers and other health practitioners. Information will be provided on the ipad about contacts with relevant health professionals. Psychotherapy will be structured by assessment, diagnosis, formulation, implementation of formulation and evaluation of process, centered around behaviors of the care recipient and the carers thoughts feelings and and behavior.

We will seek approval for all study intervention contacts between therapists and participants to be recorded. The investigators will review individual intervention contacts with each therapist at 1-week, 3-weeks and 6- weeks to ensure adherence to the study protocol.
Intervention code [1] 289246 0
Treatment: Other
Intervention code [2] 289247 0
Behaviour
Comparator / control treatment
Participants assigned to the control group will receive standard care plus the standard Stroke Foundation hard copy information pack and assessment feedback including follow-up assessment. Standard care from a participating stroke unit will usually require outpatient neurology follow-up and community management of risk factors and medical conditions with the participants own General Practitioner. Control participants recruited from the community will continue to use current community supports.
Control group
Active

Outcomes
Primary outcome [1] 291986 0
Carer self-efficacy as measured by the Revised scale for caregiving self-efficacy
Timepoint [1] 291986 0
6, 12, 18 and 24-months
Primary outcome [2] 291987 0
Carer strain as measured by the Carer Strain Index
Timepoint [2] 291987 0
6, 12, 18 and 24-months
Primary outcome [3] 291988 0
Carer mood (anxiety and depression) measured by the PHQ-9 and Hamilton Depression Rating Scale.
Timepoint [3] 291988 0
6, 12, 18 and 24-months
Secondary outcome [1] 307961 0
Health-related quality of life measured by the AQoL-4
Timepoint [1] 307961 0
6, 12, 18 and 24-months
Secondary outcome [2] 307962 0
The cost effectiveness of the model will be calculated using Australian data for health system costs, demographic and epidemiological parameters. Modelling will be based upon best available techniques on efficacy based upon evidence contained in systematic reviews.
Timepoint [2] 307962 0
Intervention duration.
Secondary outcome [3] 307964 0
Health Service usage will be assessed by patient diary and recorded health care visits.
Timepoint [3] 307964 0
6, 12, 18 and 24-months
Secondary outcome [4] 307965 0
carer knowledge of vascular dementia/mixed dementia will be assessed by the qualitative appraisal of written responses to set questions.
Timepoint [4] 307965 0
6, 12, 18 and 24-months
Secondary outcome [5] 307966 0
Carer knowledge of risk factors will be assessed by the qualitative appraisal of written responses to set questions.
Timepoint [5] 307966 0
6, 12, 18 and 24-months
Secondary outcome [6] 307969 0
Cardiovascular Risk scores for the care recipient will be determined using the Australian version of the Framingham Absolute cardiovascular risk calculator.
Timepoint [6] 307969 0
12 and 24-months
Secondary outcome [7] 307970 0
Care recipient functional dependency as measured by the Barthel Index
Timepoint [7] 307970 0
6, 12, 18 and 24-months

Eligibility
Key inclusion criteria
1. Carer of a person with:
(a). History of cognitive impairment associated with stroke.
(b). Diagnosis of vascular dementia or mixed dementia.
(c). Cognitive impairment as assessed by Psychogeriatric Assessment Scale.
(d). Cognitive impairment associated with vascular dementia according to clinical judgement and imaging information obtained from consultant neurology referral.

2. Primary carer providing a minimum of 4-hours care per week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. care recipient:
(a). Alzheimer's Disease only.
(b). Absence of vascular disease.
(c). Life-expectancy less than study term.
(d). Serious illness or comorbidities affecting study participation.
(e) Likely transfer into high level care during study term.

2. Carer:
(a). Serious illness affecting ability to participate in study procedures.
(b). Cognitive impairment that would affect the ability to take part in study procedures.

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)
Carers of people with a history of cognitive impairment associated with stroke or a history of dementia will be screened by to determine eligibility. For those determined eligible to enter the study a baseline assessment will be undertaken blind to allocation using a clinical baseline assessment interview comprising the standard scales mentioned. Randomization will then occur to either the intervention or usual care as completed by the blinded trial statistician. Participants will be either assigned to to a telephone therapist or current standard of care available in the community.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence available to the trial statistician but not other research staff will be used to produce randomized allocation using a randomised permuted block design in order to maintain approximately balanced randomization across sites throughout the trial. Assessors will be blinded, but therapists will be unblinded to treatment allocation.
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
For carer efficacy, to detect a standardised interaction effect of 0.15 (based on published mean effect sizes) we would need at least a sample of 45 participants per group (calculated using G-power). Using published mean effect size for studies of mood change achieved as a result of cognitive behaviour therapy we would need at least 65 participants per group to achieve 80% power at the 0.05 alpha error probability level. Assuming 10% dropout we therefore conservatively estimate we would need at least 140 participants enrolled in the trial.

The null hypothesis is that there is no difference at follow-up assessment between groups in primary outcome measures. The adequacy of the randomization procedures will be assessed by comparison of all baseline characteristics between the two study groups. Non-paired comparisons will be done for intervention and control groups. The statistical test for comparison of baseline and follow up scores will depend on the skewness of distribution of responses. Change in knowledge and caring efficacy before and after implementing the study tool will be analyzed using paired Wilcoxon rank tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289145 0
Self funded/Unfunded
Name [1] 289145 0
Country [1] 289145 0
Primary sponsor type
University
Name
Australian Catholic University (ACU)
Address
Site Address:
115 Victoria Parade Fitzroy VIC 3065.
Postal Address:
Locked Bag 4115 Fitzroy MDC, Fitzroy VIC 3065.
Country
Australia
Secondary sponsor category [1] 287806 0
None
Name [1] 287806 0
Address [1] 287806 0
Country [1] 287806 0
Other collaborator category [1] 277925 0
Commercial sector/Industry
Name [1] 277925 0
Catholic Homes
Address [1] 277925 0
Suite B2 Domeville Avenue,
Hawthorn VIC 3122
Country [1] 277925 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290916 0
Australian Catholic University
Ethics committee address [1] 290916 0
Ethics committee country [1] 290916 0
Australia
Date submitted for ethics approval [1] 290916 0
26/05/2014
Approval date [1] 290916 0
Ethics approval number [1] 290916 0

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

Contacts
Principal investigator
Name 47938 0
Prof Colleen Doyle
Address 47938 0
Australian Catholic University.
Catholic Homes.
Suite B, 2 Domville Ave
Hawthorn VIC 3122
Country 47938 0
Australia
Phone 47938 0
+61 3 9819 1539
Fax 47938 0
+61 3 9819 1196
Email 47938 0
[email protected]
Contact person for public queries
Name 47939 0
David Jackson
Address 47939 0
Australian Catholic University
Catholic Homes.
Suite B, 2 Domville Ave
Hawthorn VIC 3122
Country 47939 0
Australia
Phone 47939 0
+61 3 9819 1539
Fax 47939 0
+61 3 9819 1196
Email 47939 0
[email protected]
Contact person for scientific queries
Name 47940 0
David Jackson
Address 47940 0
Australian Catholic University
Catholic Homes.
Suite B, 2 Domville Ave
Hawthorn VIC 3122
Country 47940 0
Australia
Phone 47940 0
+61 3 9819 1539
Fax 47940 0
+61 3 9819 1196
Email 47940 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

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