The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000388213
Ethics application status
Approved
Date submitted
18/04/2016
Date registered
15/03/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rolling it out: Intervention to improve driving cessation outcomes for people with dementia and their families across metropolitan and regional areas
Scientific title
Cluster randomised controlled trial of an intervention to improve driving cessation outcomes for people with dementia and families across metropolitan and regional areas
Secondary ID [1] 288500 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CarFreeMe-Dementia (Cluster RCT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 297565 0
community mobility / lifespace 297566 0
social isolation 297567 0
wellbeing 297569 0
Condition category
Condition code
Neurological 297764 297764 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CarFreeMe for people with dementia is a comprehensive support and education based intervention to improve driving cessation outcomes for people with dementia and their family members. The intervention includes seven modules that cover education and practical support, delivered by a health professional who is trained in, for example, occupational therapy, psychology, or nursing, and who is experienced in working in community care with older adults with dementia and their family members. Health professionals, trained in delivery of CarFreeMe, will deliver the intervention to people with dementia and their families in their homes and/or community settings. The intervention is individualised according to geographic location and the particular needs and preferences of participants and is intended to be flexible. The individualised program involves a combination of one-to-one sessions, groups, practical outings and activities with a local experienced health professional, as well as home-based independent written and verbal activities. Delivery will involve 7 x 1 hour sessions, once per week for 7 weeks.
Intervention code [1] 294103 0
Treatment: Other
Intervention code [2] 294572 0
Lifestyle
Comparator / control treatment
Control condition is treatment as usual, ie. printed information such as pamphlets outlining tips for giving up driving.
Control group
Active

Outcomes
Primary outcome [1] 297982 0
Lifespace / Community mobility collected via a study provided Smartphone using passive collection of GPS data. GPS data will be collected for a seven day period at each of three timepoints. In addition lifespace is measured with the Lifespace Questionnaire (Stalvey, Owsley, Sloane, & Ball, K. 1999) at each of three timepoints. These measures will be augmented with collecting the 'number of episodes away from home during the past week' at each of three time points.
Timepoint [1] 297982 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [1] 322823 0
Depression, measured by the Geriatric Depression Scale (Yesavage, J., Brink T., & Rose, 2000).
Timepoint [1] 322823 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [2] 322828 0
Anxiety, measured by the Geriatric Anxiety Index (Pachana, N., Byrne, G., Siddle, H., Koloski, N., Harley, E., & Arnold, E. 2007).
Timepoint [2] 322828 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [3] 323091 0
Individual Goal Setting will be conducted with participants, using the Canadian Occupational Performance Measure (Law et al., 1998)
Timepoint [3] 323091 0
Goal setting Time 1, ie. as part of the intervention, and 'satisfaction' re. goals at Times 2 and 3.
Secondary outcome [4] 323101 0
Wellbeing measured by the Personal Wellbeing Index (Cummins, Eckersley, Pallant, Van Vugt, & Misajon. 2003).
Timepoint [4] 323101 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [5] 323102 0
Self-efficacy measured by the Caregiver Transport and Lifestyle Self Efficacy item (Liddle, J., Sidhu, R., Gustafsson, L., & Pachana, N. 2015)
Timepoint [5] 323102 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [6] 344181 0
Caregiver strain measured by the Caregiver Burden Index.
Timepoint [6] 344181 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
Secondary outcome [7] 344182 0
Readiness for Mobility Transition measured by Assessment of Readiness for Mobility Transition (ARMT):A Tool for Mobility Transition Counseling (MTC)
Timepoint [7] 344182 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months

Eligibility
Key inclusion criteria
(1) the person with dementia will be eligible to participate if he/she has mild to moderate dementia (Mini-Mental State Examination score 12-26 (inclusive), or clinical diagnosis), is living in the community, has ceased driving or plans to cease driving in the next six months and driving cessation is an issue for him/her, and is able to provide informed consent for participation (or have a guardian able to do so) and has a family member/carer able to participate in the trial; (2) family members will be eligible to participate if they identify as the main person providing ongoing informal care of the person with dementia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Persons with dementia may be excluded from participation if they have never obtained a drivers' license or have ceased driving some years ago (2 or more years), have a major physical illness or sensory impairment (or reason other than dementia) that resulted in their stopping driving; or insufficient command of English to be able to respond to study questionnaires.
Family members or support persons may be excluded if they are younger than 18 years of age, or they do not have informal care of the person with dementia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque, sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clusters will be matched based on similar available health and transport infrastructure in the local area. Clusters will be randomly assigned using a simple lottery method to either the experimental or wait-list control conditions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The power calculations for sample size are based on the differences observed in the lifespace metrics scores in an earlier driving cessation study with older people without cognitive decline. Setting alpha at 0.05 we would need 50 participants in each group to achieve a power of 0.8. Assuming a high attrition rate of 40% (given the vulnerable study population, experience from the prior study, and the challenging time around driving cessation), it is estimated that 70 dyads (persons with dementia and carer) in each of the treatment and control groups, will be required.

Primary and secondary outcomes will be compared and analysed at the individual and aggregated cluster levels using repeated measures and generalized estimating equations to adjust for clustering effects within geographical location.

Recruitment
Recruitment status
Recruiting
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)
NSW,QLD

Funding & Sponsors
Funding source category [1] 293392 0
Government body
Name [1] 293392 0
National Health & Medicial Research Council (NHMRC)
Address [1] 293392 0
Level 1, 16 Marcus Clarke Street, Canberra ACT 2601
Country [1] 293392 0
Australia
Funding source category [2] 298927 0
Government body
Name [2] 298927 0
Australian Research Council (ARC)
Address [2] 298927 0
Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
Country [2] 298927 0
Australia
Primary sponsor type
Individual
Name
Dr Theresa Scott
Address
School of Psychology
McElwain Building
The University of Queensland
Sir Fred Schonell Drive
St Lucia, Qld 4072
Country
Australia
Secondary sponsor category [1] 292220 0
None
Name [1] 292220 0
Address [1] 292220 0
Country [1] 292220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294849 0
The University of Queensland Institutional Human Research Ethics Approval
Ethics committee address [1] 294849 0
The University of Queensland
Sir Fred Schonell Drive
St Lucia Qld 4072
Ethics committee country [1] 294849 0
Australia
Date submitted for ethics approval [1] 294849 0
29/06/2017
Approval date [1] 294849 0
28/08/2017
Ethics approval number [1] 294849 0
2017000936

Summary
Brief summary
This project investigates the effectiveness of the evidence-based driving cessation intervention for people with dementia and their family members who are retiring from driving, through a cluster randomised controlled trial.

Stopping driving impacts health and quality of life for people with dementia and their care partners, and poses considerable challenges to health professionals who monitor driving issues. Although a diagnosis of dementia does not immediately disqualify someone from safe driving, eventually they will need to stop. Without intensive practical and emotional support to plan for, and eventually, cease driving, people with dementia are at high risk for depression, anxiety, grief, social isolation, unsafe and unlicensed driving and injury. We have developed a comprehensive support- and education-based intervention targeted at people with dementia and their care partners and family members to manage the transition from driving to non-driving status. The intervention is a translation of a proven driving cessation intervention for people without cognitive decline (CarFreeMe, formerly UQDrive) and is based on what people who have experienced driving cessation said that they needed to adjust, and stay active and engaged. The intervention is unique in that it is focused on both the practical and emotional issues that are experienced as a result of driving cessation.

The intervention includes seven modules that cover education and practical support, delivered by an experienced health professional who is trained in CarFreeMe delivery. It is anticipated that trained health professionals will deliver the intervention to people with dementia and their families in their homes and/or community settings. The intervention is individualised according to geographic location and the particular needs and preferences of participants and is intended to be flexible. The individualised program involves a combination of one-to-one sessions, groups, practical outings and activities with a local experienced health professional, as well as home-based independent written and verbal activities.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63390 0
Dr Theresa Scott
Address 63390 0
School of Psychology
The University of Queensland
Sir Fred Schonell Drive
St Lucia Qld 4072
Country 63390 0
Australia
Phone 63390 0
+61 7 3443 2546
Fax 63390 0
Email 63390 0
theresa.scott@uq.edu.au
Contact person for public queries
Name 63391 0
Dr Theresa Scott
Address 63391 0
School of Psychology
The University of Queensland
Sir Fred Schonell Drive
St Lucia Qld 4072
Country 63391 0
Australia
Phone 63391 0
+61 7 3443 2546
Fax 63391 0
Email 63391 0
theresa.scott@uq.edu.au
Contact person for scientific queries
Name 63392 0
Dr Theresa Scott
Address 63392 0
School of Psychology
The University of Queensland
Sir Fred Schonell Drive
St Lucia Qld 4072
Country 63392 0
Australia
Phone 63392 0
+61 7 3443 2546
Fax 63392 0
Email 63392 0
theresa.scott@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No permission has been granted by study participants to make their individual participant data available
What supporting documents are/will be available?
No other documents available
Summary results
No Results