Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000094875
Ethics application status
Approved
Date submitted
18/01/2012
Date registered
18/01/2012
Date last updated
12/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to improve depression in family carers through a physical activity intervention
Scientific title
A randomised controlled trial to improve depression in family carers through a physical activity intervention
Secondary ID [1] 279753 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMPACCT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carers with depression 285620 0
Condition category
Condition code
Public Health 285809 285809 0 0
Health promotion/education
Mental Health 285810 285810 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six month physical activity program -
An individualised home based strength, balance and walking programme (based on the Otago programme) for care recipient/carer dyads (that they can do together). It will be prescribed by the intervention physiotherapist for both the carer and the care recipient during a home visit within two weeks of baseline assessment. Although the functional levels are likely to vary, the intervention physiotherapist will aim to select several common exercises for the carer and care recipient with variation in elements to modify the specific difficulty of the exercise to the individual. In this way the carer/care recipient dyad will be able to have some common elements to share as they exercise together. Each participant will receive 4-8 exercises, to be performed at least five days each week at home (average duration around 20 minutes), and a walking program (where possible, the carer and care recipient will walk together). The intervention physiotherapist will perform a further four home visits over the 6-month duration of the exercise program, to review exercises, change exercises if indicated, and to encourage and support ongoing participation and adherence to the program.
Intervention code [1] 284072 0
Rehabilitation
Intervention code [2] 284073 0
Lifestyle
Intervention code [3] 284074 0
Treatment: Other
Comparator / control treatment
Six month social visits -
To ensure an equivalent level of contact to the intervention group, participants in the social visit control group will receive an initial home visit and four further home visits from a RA. The topics of conversation will be structured and standardised.

A third arm will also be included. The usual care control group will receive an initial phone call to explain group allocation and data collection. Usual care is defined as as would normally accur if participiant was not involved in the research study.
Control group
Active

Outcomes
Primary outcome [1] 286325 0
Carer Depression - Geriatric Depression Scale
Timepoint [1] 286325 0
0,6,12 months
Secondary outcome [1] 295603 0
Carer Activity level as measured by Human Activity Profile
Timepoint [1] 295603 0
0,6,12 months
Secondary outcome [2] 295608 0
Care recipient depression as measured by Geriatric Depression Scale
Timepoint [2] 295608 0
0, 6, 12 months
Secondary outcome [3] 295609 0
Care recipient activity level as measured by the Human Activity Profile
Timepoint [3] 295609 0
0, 6, 12 months
Secondary outcome [4] 295610 0
Whether the intervention is cost effective by a health economic evaluation. It will considers the efficiency of the intervention in reducing the proportion of carers who are depressed (GDS > 5) at the final follow-up assessment compared to the control conditions. Direct health costs (using Medicare and Pharmaceutical Benefits Scheme databases, patient log and interview at assessment points), costs of providing the intervention, non-health costs , and indirect costs (eg productivity losses incurred by care-givers having to take time off other work in order to care for participant will be considered from the societal perspective.
Timepoint [4] 295610 0
0, 6, 12 months

Eligibility
Key inclusion criteria
Carer aged over 55 years
Care Recipient aged over 60 years
Both live at home
Care recipient is dependent in at least one activity of daily living
Carer has 5 or more depressive symptoms as measured on the GDS
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carer less than 55 years
Care recipient less than 60 years
Care recipients who do not have an informal co-resident carer
Carers who do not live with the care recipient
Carers who do not have 5 or more depressive symptoms
Either declining consent to participate
Carers who do not have the cognitive capacity to give informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2012
Actual
11/05/2012
Date of last participant enrolment
Anticipated
Actual
9/09/2015
Date of last data collection
Anticipated
Actual
12/10/2016
Sample size
Target
546
Accrual to date
Final
212
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284541 0
Government body
Name [1] 284541 0
National Health and Medical Research Council
Country [1] 284541 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
P.O. Box 2127
Royal Melbourne Hospital
VIc 3050
Country
Australia
Secondary sponsor category [1] 283469 0
None
Name [1] 283469 0
Address [1] 283469 0
Country [1] 283469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286527 0
Melbourne Health HREC
Ethics committee address [1] 286527 0
Ethics committee country [1] 286527 0
Date submitted for ethics approval [1] 286527 0
25/01/2012
Approval date [1] 286527 0
21/02/2012
Ethics approval number [1] 286527 0
2012-41

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

Contacts
Principal investigator
Name 33652 0
A/Prof Briony Dow
Address 33652 0
P.O. Box 2127 Royal Melbourne Hospital Vic 3050
Country 33652 0
Australia
Phone 33652 0
61 3 83872639
Fax 33652 0
Email 33652 0
[email protected]
Contact person for public queries
Name 16899 0
Sue Malta
Address 16899 0
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 16899 0
Australia
Phone 16899 0
+61 3 8387 2614
Fax 16899 0
Email 16899 0
[email protected]
Contact person for scientific queries
Name 7827 0
Briony Dow
Address 7827 0
P.O. Box 2127
Royal Melbourne Hospital
Vic 3050
Country 7827 0
Australia
Phone 7827 0
+61 3 8387 2639
Fax 7827 0
Email 7827 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
No additional documents have been identified.