Contact information
Type
Scientific
Primary contact
Dr Christine Stirling
ORCID ID
Contact details
Clinical School
43 Collins Street
Private Bag 135
Hobart
7000
Australia
+61 (0)3 6226 4678
Christine.Stirling@utas.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Carer decision support: pilot evaluation of the GOLD Book decision aid for carers of people with dementia - a randomised controlled trial
Acronym
Study hypothesis
The hypothesis to be tested is that a decision aid will lower primary dementia carers burden by improving their ability to make community service decisions
Ethics approval
Tasmania Health & Medical Human Research Ethics Committee approved on 26th March 2010, ref: H0010985
Study design
Randomised parallel wait-listed control study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stress and decisional conflict in carers of people with dementia
Intervention
The GOLD Book decision aid will be given to the intervention group, with control group receiving normal service support. Control group partiicpants will receive the GOLD Book decision aid after the 3 months follow-up data collection.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The Modified Carergiver Strain Index (MCSI) is a 13 item measure used to measure carer stress. The outcomes of the intervention will be assessed by comparisons between control and intervention groups at baseline (Time 1) and three months post intervention (Time 3), with the intervention given one week after baseline data is collected. Surveys will be delivered through face to face and phone interview.
Secondary outcome measures
1. Carer decisional state will be ascertained using the Decisional Conflict Scale (O'Connor 1993/2005), a 16 item survey that yields a 5 scale measure of decisional uncertainty, and the Control Preferences Scale (Degner et al. 1997), which measures treatment decision making using 5 response statements.
2. Knowledge of dementia using a researcher generated knowledge survey
3. The outcomes of the intervention will be assessed by comparisons between control and intervention groups at baseline (Time 1) and three months post intervention (Time 3), with the intervention given one week after baseline data is collected. Surveys will be delivered through face to face and phone interview.
Overall trial start date
01/02/2010
Overall trial end date
01/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary carers of people with dementia living in the community
2. Aged 18+. self-identified as primary carers for a person with dementia
3. Able to read and speak English
4. These carers will be informal in the sense that they will be family members or friends and will not be undertaking care in a paid capacity
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Children and/or young people (ie. <18 years)
2. People with an intellectual or mental impairment
3. Women who are pregnant
4. People highly dependent on medical care
Recruitment start date
01/02/2010
Recruitment end date
01/02/2011
Locations
Countries of recruitment
Australia
Trial participating centre
Clinical School
Hobart
7000
Australia
Sponsor information
Organisation
Wicking Dementia Research and Education Centre (Australia)
Sponsor details
17 Liverpool Street
Private Bag 23
Hobart
7000
Australia
+61 (0)3 6226 4881
wicking.enquiries@menzies.utas.edu.au
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Wicking Dementia Research and Education Centre (Australia) - Menzies Research Institute
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Tasmania (Australia)
Alternative name(s)
UTAS
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary