Condition category
Mental and Behavioural Disorders
Date applied
18/07/2011
Date assigned
10/08/2011
Last edited
02/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

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

http://www.utas.edu.au/wicking/

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

Publication citations

Additional files

Editorial Notes