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GOLD Book Carer decision support for carers of people with dementia
ISRCTN ISRCTN32163031
DOI 10.1186/ISRCTN32163031
ClinicalTrials.gov identifier
EudraCT number
Public title GOLD Book Carer decision support for carers of people with dementia
Scientific title Carer decision support: pilot evaluation of the GOLD Book decision aid for carers of people with dementia - a randomised controlled trial
Acronym N/A
Serial number at source N/A
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
Lay summary Lay summary under review 3
Ethics approval Tasmania Health & Medical Human Research Ethics Committee approved on 26th March 2010, ref: H0010985
Study design Randomised parallel wait-listed control study
Countries of recruitment Australia
Disease/condition/study domain Stress and decisional conflict in carers of people with dementia
Participants - 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
Participants - 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
Anticipated start date 01/02/2010
Anticipated end date 01/02/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 60
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding 1. Wicking Dementia Research and Education Centre (Australia) - Menzies Research Institute
2. University of Tasmania (Australia)
Trial website
Publications
Contact name Dr  Christine  Stirling
  Address Clinical School
43 Collins Street
Private Bag 135
  City/town Hobart
  Zip/Postcode 7000
  Country Australia
  Tel +61 (0)3 6226 4678
  Fax +61 (0)3 6226 4690
  Email Christine.Stirling@utas.edu.au
Sponsor Wicking Dementia Research and Education Centre (Australia)
  Address 17 Liverpool Street
Private Bag 23
  City/town Hobart
  Zip/Postcode 7000
  Country Australia
  Tel +61 (0)3 6226 4881
  Email wicking.enquiries@menzies.utas.edu.au
  Sponsor website: http://www.utas.edu.au/wicking/
Date applied 18/07/2011
Last edited 02/08/2012
Date ISRCTN assigned 10/08/2011
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