Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000466246
Ethics application status
Approved
Date submitted
23/03/2018
Date registered
29/03/2018
Date last updated
30/11/2023
Date data sharing statement initially provided
27/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Living with dementia and driving: A telehealth delivered Intervention to improve driving cessation outcomes for people with dementia and their families
Scientific title
An innovative telehealth approach to supporting older adults with dementia with driving cessation and mobility: Cluster randomised controlled trial
Secondary ID [1] 294285 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CarFreeMe-Dementia (Telehealth Cluster RCT)
Linked study record
This study is a telehealth delivered version of the the CarFreeMe intervention for people with dementia, it is linked to ACTRN12618000388213 face-to-face trial.

Health condition
Health condition(s) or problem(s) studied:
dementia 306976 0
community mobility / lifespace 306977 0
social isolation 307185 0
wellbeing 307186 0
Condition category
Condition code
Neurological 306071 306071 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 - delivered via telehealth technology - includes seven modules that cover education and practical support, delivered by health professionals who are trained in, for example, occupational therapy, psychology, or nursing. A telehealth-based 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 via telehealth technology, with some local health professional support (e.g. to set up and trouble shoot in home). 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, and 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. The intervention is delivered instead of treatment as usual.
Intervention code [1] 300582 0
Treatment: Other
Intervention code [2] 300583 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] 305120 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 four timepoints. In addition lifespace is measured with the Lifespace Questionnaire (Stalvey, Owsley, Sloane, & Ball, K. 1999) at each of four timepoints.
Timepoint [1] 305120 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8 [primary timepoint]
T3 = Second Follow-up, at 3 months post intervention completion [primary timepoint]
T4 = Third Follow-up, at 6 months [primary timepoint]
Secondary outcome [1] 344247 0
Depression, measured by the Geriatric Depression Scale (Yesavage, J., Brink T., & Rose, 2000).
Timepoint [1] 344247 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [2] 344809 0
Anxiety, measured by the Geriatric Anxiety Index (Pachana, N., Byrne, G., Siddle, H., Koloski, N., Harley, E., & Arnold, E. 2007).
Timepoint [2] 344809 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [3] 344810 0
Individual Goal setting will be conducted with participants, using the Canadian Occupational Performance Measure (Law et al., 1998)
Timepoint [3] 344810 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [4] 344811 0
Wellbeing measured by the Personal Wellbeing Index (Cummins, Eckersley, Pallant, Van Vugt, & Misajon. 2003).
Timepoint [4] 344811 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [5] 344812 0
Self-efficacy measured by the Caregiver Transport and Lifestyle Self Efficacy item (Liddle, J., Sidhu, R., Gustafsson, L., & Pachana, N. 2015)
Timepoint [5] 344812 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [6] 344813 0
Caregiver strain measured by the Caregiver Burden Index.
Timepoint [6] 344813 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [7] 344814 0
Readiness for Mobility Transition measured by Assessment of Readiness for Mobility Transition (ARMT):A Tool for Mobility Transition Counseling (MTC)
Timepoint [7] 344814 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 months
Secondary outcome [8] 344816 0
The composite outcome measure: 'number of episodes away from home during the past week' will be counted and the relative 'mode of transport' used (for each of these episodes) will be collected at each of four time points, through semi-structured interview with participants.
Timepoint [8] 344816 0
T1 = Baseline, prior to commencement
T2 = First follow-up, at week 8
T3 = Second Follow-up, at 3 months post intervention completion
T4 = Third Follow-up, at 6 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
Sex
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 randomly assigned to either intervention or control. 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 - blinded researcher draws names (on folded pieces of paper) from an opaque envelope - to either the intervention or control conditions. Participants (dyads) will therefore be assigned to either intervention or control based on their locality (cluster).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
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
Completed
Date of first participant enrolment
Anticipated
2/04/2018
Actual
3/04/2018
Date of last participant enrolment
Anticipated
31/12/2022
Actual
28/02/2023
Date of last data collection
Anticipated
28/02/2023
Actual
31/07/2023
Sample size
Target
144
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 298928 0
Government body
Name [1] 298928 0
National Health & Medicial Research Council (NHMRC)
Country [1] 298928 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] 298306 0
None
Name [1] 298306 0
Address [1] 298306 0
Country [1] 298306 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299864 0
The University of Queensland Institutional Human Research Ethics Approval
Ethics committee address [1] 299864 0
Ethics committee country [1] 299864 0
Australia
Date submitted for ethics approval [1] 299864 0
17/11/2017
Approval date [1] 299864 0
15/02/2018
Ethics approval number [1] 299864 0
2018000040

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2529 2529 0 0
/AnzctrAttachments/374687-Telehealth trial_CFM_2018000040 - Approval Form HRECA.pdf (Ethics approval)

Contacts
Principal investigator
Name 81806 0
Dr Theresa Scott
Address 81806 0
School of Psychology
The University of Queensland Sir Fred Schonell Drive
St Lucia Qld 4072
Country 81806 0
Australia
Phone 81806 0
+61 7 3443 2546
Fax 81806 0
Email 81806 0
[email protected]
Contact person for public queries
Name 81807 0
Theresa Scott
Address 81807 0
School of Psychology
The University of Queensland Sir Fred Schonell Drive
St Lucia Qld 4072
Country 81807 0
Australia
Phone 81807 0
+61 7 3443 2546
Fax 81807 0
Email 81807 0
[email protected]
Contact person for scientific queries
Name 81808 0
Theresa Scott
Address 81808 0
School of Psychology
The University of Queensland Sir Fred Schonell Drive
St Lucia Qld 4072
Country 81808 0
Australia
Phone 81808 0
+61 7 3443 2546
Fax 81808 0
Email 81808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have the necessary permissions in place from participants


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.