Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000927426p
Ethics application status
Not yet submitted
Date submitted
9/06/2016
Date registered
12/07/2016
Date last updated
12/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the 'Support for Life' program on improving quality of life for people with dementia or cognitive decline and their families or carers
Scientific title
A cluster randomised controlled trial evaluating the efficacy of the 'Support for Life' program on improving quality of life for people with dementia or cognitive decline and their families or carers
Secondary ID [1] 289403 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 299071 0
Condition category
Condition code
Neurological 299107 299107 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention
Group A participants will be from Group A cluster sites and will have access to the “Support for Life” intervention from year 1. An highly experienced dementia support worker will provide a holistic, highly flexible, individualised approach to support people with cognitive impairment or dementia and their families and or carers. .Support will be relationship-centred (responding to individual needs) and focused on enablement as opposed to dysfunction. Education about dementia and information/resources will be provided to participants as well as advocacy and practical support to navigate dementia services and healthcare with an aim to also enhance continuity of care. Additionally, the dementia support worker will also provide psychological support and facilitate participants continued participation in their community and social engagement. The mode of support will consist of a combination of face to face, telephone and internet. interaction on an as needs basis for a duration of 12 months. The dementia support worker will deliver the intervention in the participants home or at mutually suitable locations as required/requested. (Group A).
Intervention code [1] 294988 0
Lifestyle
Intervention code [2] 294989 0
Behaviour
Intervention code [3] 294990 0
Rehabilitation
Comparator / control treatment
Group B participants will continue to receive usual care by health service providers and will not be denied information on dementia or dementia services in year one. In year 2 Group B participants will have access to the “Support for Life” intervention.
Control group
Active

Outcomes
Primary outcome [1] 298579 0
Mean quality of life of people experiencing memory loss or dementia assessed using QoL-AD
Timepoint [1] 298579 0
Baseline and three, six and twelve months post-randomisation
Primary outcome [2] 298580 0
Mean level of well being of carer/members of family unit assessed using the Carer Experience Scale
Timepoint [2] 298580 0
Baseline and three, six and twelve months post-randomisation
Secondary outcome [1] 324617 0
Proportion of participants that experience delay in accessing residential care measured using qualitative interviews/client records/case notes documenting support worker interactions.
Timepoint [1] 324617 0
Baseline and six and twelve months post randomisation
Secondary outcome [2] 324618 0
Proportion of participants that experience change in health service utilisation measured by client records Resource Utilisation in Dementia (RUD)/health records snf EQ-5D-5L.
Timepoint [2] 324618 0
Baseline and six and twelve months post randomisation
Secondary outcome [3] 324619 0
Proportion of participants that experience an increase in uptake of support/respite services/engagement in activities measured using client health service records/interviews
Timepoint [3] 324619 0
Baseline and six and twelve months post randomisation
Secondary outcome [4] 324620 0
Economic analysis will be undertaken using health care service records - data linkage to medicare cost records, carer time (paid/unpaid) and permanent admission to residential care,
case notes documenting support worker interactions, time spent, referrals etc.
Timepoint [4] 324620 0
Baseline and twelve months post randomisation
Secondary outcome [5] 325338 0
Reduction in symptoms of depression in the person with dementia measured by GDS 15
Timepoint [5] 325338 0
Baseline and three, six and twelve months post-randomisation
Secondary outcome [6] 325341 0
Proportion of carers/family members measured by qualitative interviews who report an increase in their social engagement/ability to continue with regular activities
Timepoint [6] 325341 0
Baseline, six and twelve months post-randomisation
Secondary outcome [7] 325345 0
Proportion of carers/family members who report a decrease in depression/carer stress measured by qualitatitive interview .
Timepoint [7] 325345 0
Baseline, six and twelve months post-randomisation

Eligibility
Key inclusion criteria
Criteria for inclusion will include consumers who are experiencing memory problems, cognitive decline or who have a diagnosis of dementia and are willing to provide written, informed consent to participate in the study. Consumers who are unable to self-manage but who have a carer will not be excluded from the study. Carers and family members of a person who is experiencing memory problems, cognitive decline or dementia and are willing to provide written, informed consent are also eligible for participation in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria includes consumers who are unable to self-manage and do not have a carer and consumers/clients or family members who are already receiving a support intervention, or have acute psychosis.

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)
Computer generated randomisaton of group A and group B will be performed by an independent researcher after the baseline data is collected.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants with dementia and their carers/family members will be randomly selected from community health centre client lists in each of the three states and then randomly selected to receive either the dementia ‘Support for Life’ program (Group A, n=50) or routine care only (Group B, n =50).

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants symptoms and institutionalization, and caregivers/family members quality of life, stress and social support at baseline, 3 months, 6 months and 12 months following intervention will be measured and compared between study groups using repeated measures.
The sample size required is 30 clusters with 10 participant/families, in each to allow for an attrition of 20%. This is a total of 100 participant/families (50 in each group) in each of the 3 states making a total sample size of 300. This will detect significant differences in caregiver’s and consumer’s quality of life between two groups at effect sizes of 0.39 (small-medium effects). Sample size calculations were done using Stata statistical software stepped-wedge: for clusters defined at the level of the community health centre, the primary outcome measure of QOL-AD, with scores between 15-60 and standard deviation of 7 power of 0.80, significance level set at 0.05, intraclass correlation coefficient (ICC) of 0.05, the number of steps (2), and participant data collected at four time points (baseline, three months, six months and 12 months).
Statistical analysis: all data will be analysed using SPSS version 21 (IBM, Chicago).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/01/2017
Actual
Date of last participant enrolment
Anticipated
9/01/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 293779 0
Government body
Name [1] 293779 0
NHMRC:Cognitive Decline Partnership Centre (CDPC) University of Sydney
Country [1] 293779 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
NHMRC Cognitive Decline Partnership Centre (CDPC)
Level 3, Old Leighton Lodge (building 8)
Hornsby Kur-ring-ga Hospital
Palmerston Rd,
Horsnby
NSW 2077
Country
Australia
Secondary sponsor category [1] 292615 0
None
Name [1] 292615 0
Address [1] 292615 0
Country [1] 292615 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295218 0
Royal District Nursing Service Human Research Ethics Committee
Ethics committee address [1] 295218 0
Ethics committee country [1] 295218 0
Australia
Date submitted for ethics approval [1] 295218 0
11/10/2016
Approval date [1] 295218 0
Ethics approval number [1] 295218 0

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

Contacts
Principal investigator
Name 66558 0
Dr Dianne Goeman
Address 66558 0
RDNS Institute
31 Alma Rd
St Kilda, 3182
Victoria
Country 66558 0
Australia
Phone 66558 0
+61 3 9536 5318
Fax 66558 0
Email 66558 0
[email protected]
Contact person for public queries
Name 66559 0
Dianne Goeman
Address 66559 0
RDNS Institute
31 Alma Rd
St Kilda, 3182
Victoria
Country 66559 0
Australia
Phone 66559 0
+61 3 9536 5318
Fax 66559 0
Email 66559 0
[email protected]
Contact person for scientific queries
Name 66560 0
Dianne Goeman
Address 66560 0
RDNS Institute
31 Alma Rd
St Kilda, 3182
Victoria
Country 66560 0
Australia
Phone 66560 0
+61 3 9536 5318
Fax 66560 0
Email 66560 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.