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Trial registered on ANZCTR


Registration number
ACTRN12613000174785
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
12/02/2013
Date last updated
28/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a novel decision aid for drivers with dementia and its effect on decisional conflict
Scientific title
Development of a novel decision aid for drivers with dementia and its effect on decisional conflict
Secondary ID [1] 281925 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 288325 0
Driving retirement 288326 0
Condition category
Condition code
Neurological 288678 288678 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) The intervention in this study is a decision aid booklet. This can be read by participants alone and unaided but may be read in the presence of others if wished.
b) Each participant that receives a decision aid booklet will read it once. They will then undergo a telephone survey one week later. They may then either keep or discard the booklet. They may reread it as often as they wish.
c) Every participant will be surveyed twice. The first and second telephone surveys will be conducted one week apart. No other contact will be made with participants.
Intervention code [1] 286487 0
Behaviour
Comparator / control treatment
Comparator: usual care.

a) Usual care will involve uninterupted ongoing medical care by participants' general practitioner or specialists. All participants in the control group upon completion of the study will be provided with a decision aid booklet.

b) The participants will receive usual care for one week i.e. the time period between the first and second telephone interviews. No contact will be made by the researchers outside of this time period.
Control group
Active

Outcomes
Primary outcome [1] 288825 0
Decisional conflict -

This will be measured using the low-literacy decision conflict scale [O'Connor 1993]. This will form part of both telephone interviews.

O’Connor AM. Low literacy decisional conflict scale. Ottawa: OHRI, 1993 (updated 2010). Available from https://decisionaid.ohri.ca/eval_dcs.html.
Timepoint [1] 288825 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.
Secondary outcome [1] 301069 0
Knowledge -

This will be measured using a brief knowledge questionnaire adapted from the Ottawa knowledge questionnaire template [O'Connor 1999]. This will form part of both telephone interviews.

O’Connor AM. Ottawa knowledge questionnaire. Ottawa: OHRI, 1999. Available from http://decisionaid.ohri.ca/eval_know.html.
Timepoint [1] 301069 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.
Secondary outcome [2] 301070 0
Decision -

This will be determined by asking participants what their decision is regarding driving retirement. They will be asked if they will to continue driving unchanged, drive less, stop driving now, stop driving later or other. This will form part of both telephone interviews.
Timepoint [2] 301070 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.
Secondary outcome [3] 301071 0
Booklet acceptability -

This will be measured using an acceptability questionnaire adapted from the Ottawa acceptability questionnaire template [O'Connor 2000]. This will form part of the last telephone interview.

O’Connor AM, Cranney A. Ottawa acceptability questionnaire. Ottawa: OHRI, 2000. Available from http://decisionaid.ohri.ca/eval_accept.html.
Timepoint [3] 301071 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.
Secondary outcome [4] 301074 0
Booklet use -

Booklet use will be examined by establishing the length of time required to read the booklet and whether assistance was required by the reader to use it. This will form part of the last telephone interview.
Timepoint [4] 301074 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.
Secondary outcome [5] 301077 0
Decisional satisfaction -

Satisfaction with decision will be measured with the validated satisfaction with decision scale [Holmes-Rovner 1996]. This will form part of the first and second interview.

Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making 1996;16:58-64.
Timepoint [5] 301077 0
One week after the first telephone interview, the second telephone interview will be conducted. The participants in the intervention group will receive a copy of the decision aid booklet within 2-3 days of the first telephone interview. Thus allowing them 4-5 days to read the booklet before the second interview.

Eligibility
Key inclusion criteria
Individuals with dementia
Individuals who actively drive
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to become involved via a newsletter advertisement. If they express interest they will be forwarded a participant information sheet and consent form. Upon receipt of written consent, a research assistant will assign each participant with a code.
Each coded participant will be randomly allocated either to receive a decision aid booklet or not. Half of all participants will receive the booklet. Half will not and will serve as the control - they will receive usual care.
Concealed opaque envelopes will be used to ensure that allocation is blinded from the research assistant. As each participant is coded at the point of allocation then selection bias will not occur.
The decision aid booklets will then be mailed to half of all participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will first be coded. Then a random number generator (www.random.org) will be used to randomly allocate coded participants into either (i) intervention group - i.e. receive the booklet, or (ii) control group - i.e. no booklet but will receive usual care.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Inferential statistics will be used to determine if there is a statistically significant improvement in the primary and secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5498 0
New Zealand
State/province [1] 5498 0

Funding & Sponsors
Funding source category [1] 286709 0
Hospital
Name [1] 286709 0
Wollongong Hospital
Address [1] 286709 0
Crown Street
Wollongong
NSW 2500
Country [1] 286709 0
Australia
Primary sponsor type
Hospital
Name
Wollongong Hospital
Address
Crown Street
Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 285481 0
None
Name [1] 285481 0
Address [1] 285481 0
Country [1] 285481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288777 0
The University of Wollongong / Illawarra Shoalhaven Local Health District (ISLHD) Health and Medical HREC
Ethics committee address [1] 288777 0
Building 20
University of Wollongong
Wollongong
NSW 2522
Ethics committee country [1] 288777 0
Australia
Date submitted for ethics approval [1] 288777 0
Approval date [1] 288777 0
18/12/2012
Ethics approval number [1] 288777 0
HE 12 / 016

Summary
Brief summary
The purpose of this randomised controlled trial is to determine if the use of a decision aid by drivers with dementia results in improved decisional uncertainty/conflict. It will also involve establishing if the decision aid booklet improves participant knowlege and decisional satisfaction. Booklet use, acceptability and impact upon decision will also be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37730 0
Dr John Carmody
Address 37730 0
Neurology Department
Level 4, Block C
Wollongong Hospital
Crown Street
Wollongong
NSW 2500
Country 37730 0
Australia
Phone 37730 0
+61242534430
Fax 37730 0
+61242534436
Email 37730 0
john.carmody@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 37731 0
Dr John Carmody
Address 37731 0
Neurology Department
Level 4, Block C
Wollongong Hospital
Crown Street
Wollongong
NSW 2500
Country 37731 0
Australia
Phone 37731 0
+61242534430
Fax 37731 0
+61242534436
Email 37731 0
john.carmody@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 37732 0
Dr John Carmody
Address 37732 0
Neurology Department
Level 4, Block C
Wollongong Hospital
Crown Street
Wollongong
NSW 2500
Country 37732 0
Australia
Phone 37732 0
+61242534430
Fax 37732 0
+61242534436
Email 37732 0
john.carmody@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary