Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000375459
Ethics application status
Approved
Date submitted
13/06/2007
Date registered
16/07/2007
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a group intervention to promote older people’s adjustment to driving cessation.
Scientific title
Among older people who retire from driving within the last six months, does a group intervention (UQDRIVE) compared to current practice (no intervention) affect adjustment and wellbeing?
Secondary ID [1] 287900 0
Nil know
Universal Trial Number (UTN)
Trial acronym
UQDRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social isolation, restricted community involvement, life satisfaction, depression, anxiety among older people who retire from driving. 1955 0
Condition category
Condition code
Mental Health 2050 2050 0 0
Depression
Mental Health 2051 2051 0 0
Anxiety
Mental Health 2052 2052 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: UQDRIVE (University of Queensland Driver Retirement Initiative) Intensive Group Program.
The group intervention was developed by the research team for older people in the decision and post-cessation phases of driving cessation. It runs for one session of three to four hours per week over six weeks for approximately 12-15 participants. The program has seven modules and incorporates information-giving, discussion, guest speakers, a participant workbook and practical exercises including use of transport information services, group outings using alternative transport, pedestrian safety audits of the local area and advocacy regarding transport needs.
Intervention code [1] 1824 0
Prevention
Comparator / control treatment
Control: Current treatment available – ie no intervention. The control group will be a waitlist control group and will undertake the UQDRIVE group program after the trial is complete.
Control group
Active

Outcomes
Primary outcome [1] 2879 0
Episodes of leaving the home per week (% of participants who have increased episodes of leaving the home > 1 per week)
Timepoint [1] 2879 0
At baseline, immediately post intervention, 3 months post-intervention.
Secondary outcome [1] 4855 0
Episodes of alternative transport used in week
Timepoint [1] 4855 0
Baseline, immediately post intervention, 3 months post-intervention
Secondary outcome [2] 4856 0
Subjective life satisfaction
Timepoint [2] 4856 0
Baseline, immediately post intervention, 3 months post-intervention
Secondary outcome [3] 4857 0
Depressed mood
Timepoint [3] 4857 0
Baseline, immediately post intervention, 3 months post-intervention
Secondary outcome [4] 4858 0
Anxious mood
Timepoint [4] 4858 0
Baseline, immediately post intervention, 3 months post-intervention
Secondary outcome [5] 4859 0
Lifestyle goals self rated satisfaction and importance
Timepoint [5] 4859 0
Baseline, immediately post intervention.

Eligibility
Key inclusion criteria
People who have permanently ceased driving within the last six monthsLive in the communitySufficient health and communication to enable participation in interviews and group program
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living in Aged care facilityCognitive impairmentLimited comprehension of spoken English languageHealth does not permit participation in full group programNot available for full 6 week program

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once 24-30 eligible participants in one of the trial location consent to participate, they will be assessed at baseline 2 weeks before the intervention commences (time 1). They will then be matched into pairs by research team member not involved in the intervention or data collection, according to age (within 5 year intervals), gender and self-rated health status (5 point scale from poor to excellent). Matching will occur to ensure that the intervention effect is not confounded by variables previously linked to the dependent variables or adjustment after driving cessation. Matching is particularly useful for reducing extraneous variance in comparisons between treatment and control groups where the number of participants is relatively small. Each member of the matched pair will be randomly allocated to either treatment or control groups according to a computer-generated schedule concealed in opaque envelopes. Individuals eligible for participation in the study, but unable to be matched, will be randomly assigned to either treatment or control groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The assessor is blinded
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2007
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2195 0
Government body
Name [1] 2195 0
National Health and Medical Research Council (NHMRC) project grant
Country [1] 2195 0
Australia
Primary sponsor type
Individual
Name
A/Prof Nancy Pachana
Address
School of Psychology St Lucia Campus Sir Fred Schonell Drive University of Queensland 4072
Country
Australia
Secondary sponsor category [1] 1979 0
Individual
Name [1] 1979 0
A/Prof Kryss McKenna
Address [1] 1979 0
Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072
Country [1] 1979 0
Australia
Secondary sponsor category [2] 1980 0
Individual
Name [2] 1980 0
Dr Louise Gustaffson
Address [2] 1980 0
Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072
Country [2] 1980 0
Australia
Secondary sponsor category [3] 1981 0
Individual
Name [3] 1981 0
A/Prof Geoff Mitchell
Address [3] 1981 0
School of Medicine
Herston Campus
Herston Rd
University of Qld, 4072
Country [3] 1981 0
Australia
Secondary sponsor category [4] 1982 0
Individual
Name [4] 1982 0
Dr Michele Haynes
Address [4] 1982 0
c/- School of Psychology
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072
Country [4] 1982 0
Australia
Secondary sponsor category [5] 1983 0
Individual
Name [5] 1983 0
Dr Jacki Liddle
Address [5] 1983 0
Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072
Country [5] 1983 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3993 0
University of Queensland
Ethics committee address [1] 3993 0
Ethics committee country [1] 3993 0
Australia
Date submitted for ethics approval [1] 3993 0
Approval date [1] 3993 0
20/07/2007
Ethics approval number [1] 3993 0
20/07/2007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27638 0
Dr Louise Gustafsson
Address 27638 0
School of Health and Rehabilitation Sciences
University of Queensland
Country 27638 0
Australia
Phone 27638 0
+61 7 336 52926
Fax 27638 0
Email 27638 0
[email protected]
Contact person for public queries
Name 11013 0
Dr Jacki Liddle
Address 11013 0
Division of Occupational Therapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 11013 0
Australia
Phone 11013 0
+61 7 3346 7454
Fax 11013 0
Email 11013 0
[email protected]
Contact person for scientific queries
Name 1941 0
Associate Professor Nancy Pachana
Address 1941 0
School of Psychology
The University of Queensland
Brisbane QLD 4072
Country 1941 0
Australia
Phone 1941 0
+61 7 33656832
Fax 1941 0
+61 7 33654466
Email 1941 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIEffect of a Group Intervention to Promote Older Adults’ Adjustment to Driving Cessation on Community Mobility: A Randomized Controlled Trial2013https://doi.org/10.1093/geront/gnt019
N.B. These documents automatically identified may not have been verified by the study sponsor.