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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]

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.

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Mental Health

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]

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]

Episodes of leaving the home per week (% of participants who have increased episodes of leaving the home > 1 per week)

Timepoint [1]

At baseline, immediately post intervention, 3 months post-intervention.

Secondary outcome [1]

Episodes of alternative transport used in week

Timepoint [1]

Baseline, immediately post intervention, 3 months post-intervention

Secondary outcome [2]

Subjective life satisfaction

Timepoint [2]

Baseline, immediately post intervention, 3 months post-intervention

Secondary outcome [3]

Depressed mood

Timepoint [3]

Baseline, immediately post intervention, 3 months post-intervention

Secondary outcome [4]

Anxious mood

Timepoint [4]

Baseline, immediately post intervention, 3 months post-intervention

Secondary outcome [5]

Lifestyle goals self rated satisfaction and importance

Timepoint [5]

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?

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]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) project grant

Address [1]

http://www.nhmrc.gov.au/

Country [1]

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]

Individual

Name [1]

A/Prof Kryss McKenna

Address [1]

Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Louise Gustaffson

Address [2]

Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072

Country [2]

Australia

Secondary sponsor category [3]

Individual

Name [3]

A/Prof Geoff Mitchell

Address [3]

School of Medicine
Herston Campus
Herston Rd
University of Qld, 4072

Country [3]

Australia

Secondary sponsor category [4]

Individual

Name [4]

Dr Michele Haynes

Address [4]

c/- School of Psychology
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072

Country [4]

Australia

Secondary sponsor category [5]

Individual

Name [5]

Dr Jacki Liddle

Address [5]

Division of Occupational Therapy,
School of Health and Rehabilitation Sciences
St Lucia Campus
Sir Fred Schonell Dr
University of Qld, 4072

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Queensland

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/07/2007

Ethics approval number [1]

20/07/2007

Summary

Brief summary

As a result of age-related changes, chronic medical conditions, the side-effects of medication or a combination of these, many older people decide or are required to give up driving. Driving is a highly valued role and skill, associated with freedom, independence and convenience. Because of this, the transition to driving cessation can be traumatic and associated with depression, social isolation and compromised well-being. Despite the frequent reporting of poor outcomes for older people after driving cessation, limited attention has been given to developing and evaluating methods to help older people prepare for and cope with this transition. This study will evaluate
the effect of a group intervention on older people's episodes away from home, use of alternative transport modes, life satisfaction, depression, and self-rated performance of and satisfaction with up to five lifestyle goals related to transport. This study will contribute to evidence for the effectiveness of a group intervention versus usual practice (which is to say, no intervention) to help older people maintain their well-being and stay engaged in valued roles, activities and the community after retiring from driving. It will also contribute to the theoretical underpinnings of
adjustment after undergoing the transition to retired driver.

Trial website

Trial related presentations / publications

Liddle, J., Haynes, M., Pachana, N. A., Mitchell, G., McKenna, K., & Gustafsson, L. (2014). Effect of a group intervention to promote older adults’ adjustment to driving cessation on community mobility: a randomized controlled trial. The Gerontologist, 54(3), 409-422.
Gustafsson, L. A., Liddle, J. M., Lua, S., Hoyle, M. F., Pachana, N. A., Mitchell, G. K., & McKenna, K. T. (2011). Participant feedback and satisfaction with the UQDRIVE groups for driving cessation. Canadian Journal of Occupational Therapy, 78(2), 110-117.
Gustafsson, L., Liddle, J., Liang, P., Pachana, N., Hoyle, M., Mitchell, G., & McKenna, K. (2012). A driving cessation program to identify and improve transport and lifestyle issues of older retired and retiring drivers. International Psychogeriatrics, 24(05), 794-802.
Liddle, J., Liu, X., Aplin, T., & Gustafsson, L. (2015). The experiences of peer leaders in a driving cessation programme. British Journal of Occupational Therapy, 0308022614562403.

Public notes

Contacts

Principal investigator

Name

Dr Louise Gustafsson

Address

School of Health and Rehabilitation Sciences
University of Queensland

Country

Australia

Phone

+61 7 336 52926

Fax

l.gustafsson@uq.edu.au

Contact person for public queries

Name

Dr Jacki Liddle

Address

Division of Occupational Therapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 3346 7454

Fax

j.liddle@uq.edu.au

Contact person for scientific queries

Name

Associate Professor Nancy Pachana

Address

School of Psychology
The University of Queensland
Brisbane QLD 4072

Country

Australia

Phone

+61 7 33656832

Fax

+61 7 33654466

npachana@psy.uq.edu.au

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

Source	Title	Year of Publication	DOI
Dimensions AI	Effect of a Group Intervention to Promote Older Adults’ Adjustment to Driving Cessation on Community Mobility: A Randomized Controlled Trial	2013	https://doi.org/10.1093/geront/gnt019

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically