Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
The majority of at-home care for people with dementia is given by family members but numerous studies have shown that dementia carers experience high levels of burden, which results in poor health outcomes and quality of life for them, and earlier institutionalisation for the person with dementia. Poor health outcomes include an increased risk of psychological illnesses such as depression and anxiety and an overall increased risk of illness and death. Interventions that address carer burden are therefore essential. This study aims to help carers of people with dementia by increasing their knowledge about the trajectory of dementia, improving their participation in decision-making about community services, reducing any feelings of conflict and anxiety they may have about making care decisions, and increasing the early use of community services. We aim to do this by providing carers with the GOLD Book decision aid (GBDA).

Who can participate?
Primary carers of people with dementia living in the community, aged 18 or over.

What does the study involve?
Carers are randomly allocated to either the intervention group (who receive the GBDA in the mail) or to the control group (who receive the GBDA at the end of data collection). Participants are interviewed at the beginning, middle and end of this three-month study about their role as a carer for a person with dementia. The interviews take about 45 minutes to complete. We assess the carers’ health and stress levels, knowledge of dementia, service needs and whether they are satisfied, and how they are making decisions about care and services. At the end of the study some participants are also asked some specific questions about the book.

What are the possible benefits and risks of participating?
All participants in the study will receive a copy of the book (GBDA) that can help them think through service and support decisions. The study has no particular risks for participants, but the interview may evoke uncomfortable feelings. Assistance will be provided by the project staff to any participants who experience emotional discomfort as a result of the study.

Where is the study run from?
University of Tasmania (Australia)

When is the study starting and how long is it expected to run for?
February 2010 to February 2011

Who is funding the project?
Wicking Dementia Research and Education Centre of the Menzies Research Institute, University of Tasmania (Australia)

Who is the main contact?
Dr Christine Stirling

Trial website

Contact information



Primary contact

Dr Christine Stirling


Contact details

Clinical School
43 Collins Street
Private Bag 135
+61 (0)3 6226 4678

Additional identifiers

EudraCT number number

Protocol/serial number


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


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, 26/03/2010, ref: H0010985

Study design

Randomised parallel wait-listed control study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Stress and decisional conflict in carers of people with dementia


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Total final enrolment


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


Recruitment end date



Countries of recruitment


Trial participating centre

University of Tasmania

Sponsor information


Wicking Dementia Research and Education Centre, University of Tasmania

Sponsor details

17 Liverpool Street
Private Bag 23
+61 (0)3 6226 4881

Sponsor type

Research organisation



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


Funder name

University of Tasmania (Australia)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)



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

Basic results (scientific)

Publication list

2012 results in (added 24/01/2020)

Publication citations

Additional files

Editorial Notes

24/01/2020: The following changes have been made: 1. Publication reference added. 2. The final enrolment number has been added from the reference. 17/01/2020: Internal review. 10/02/2016: Plain English summary added