GOLD Book Carer decision support for carers of people with dementia

ISRCTN	ISRCTN32163031
DOI	https://doi.org/10.1186/ISRCTN32163031
Secondary identifying numbers	N/A

Submission date: 18/07/2011
Registration date: 10/08/2011
Last edited: 24/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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
Christine.Stirling@utas.edu.au

Contact information

Dr Christine Stirling
Scientific

Clinical School
43 Collins Street
Private Bag 135
Hobart
7000
Australia

Phone	+61 (0)3 6226 4678
Email	Christine.Stirling@utas.edu.au

Study information

Study design	Randomised parallel wait-listed control study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Carer decision support: pilot evaluation of the GOLD Book decision aid for carers of people with dementia - a randomised controlled trial
Study objectives	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(s)	Tasmania Health & Medical Human Research Ethics Committee, 26/03/2010, ref: H0010985
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2010
Completion date	01/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Total final enrolment	31
Key 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
Key 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
Date of first enrolment	01/02/2010
Date of final enrolment	01/02/2011

Locations

Countries of recruitment

Australia

Study participating centre

University of Tasmania

Hobart
7000
Australia

Sponsor information

Wicking Dementia Research and Education Centre, University of Tasmania
Research organisation

17 Liverpool Street
Private Bag 23
Hobart
7000
Australia

Phone	+61 (0)3 6226 4881
Email	wicking.enquiries@menzies.utas.edu.au
Website	http://www.utas.edu.au/wicking/
"ROR"	https://ror.org/01nfmeh72

Funders

Funder type

Research organisation

Wicking Dementia Research and Education Centre (Australia) - Menzies Research Institute

No information available

University of Tasmania (Australia)
Private sector organisation / Universities (academic only)

Alternative name(s): UTAS
Location: Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/03/2012	24/01/2020	Yes	No

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