Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000565347
Ethics application status
Approved
Date submitted
30/09/2008
Date registered
10/11/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of a frailty intervention on informal carers. A substudy of the Frailty Intervention Trial - FIT (ACTRN12608000250336)
Scientific title
The impact of a community based multidisciplinary frailty intervention for older people on informal carers' experience of caregiving.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informal caregiving 3755 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3934 3934 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a substudy of the Frailty Intervention Trial - FIT (ACTRN12608000250336).
The informal carers of the participants in the FIT study will be observed to determine if the FIT impacts on their caregiving experience.
The twelve month FIT study includes a multidimensional individualised treatment plan designed to treat identified components of frailty.
Intervention code [1] 3609 0
Not applicable
Comparator / control treatment
The informal carers of the participants in the FIT study who are randomised to the control group to recieve usual care will be observed over the course of the trial. 'Usual care' is care available to older residents from their general practitioner and community services.
Control group
Active

Outcomes
Primary outcome [1] 4822 0
Caregiver Reaction Assessment - assesses negative and positive aspects of the caregiving experience, and changes in reaction over time. The following dimensions of the caregiving experience are examined: health, daily schedule, finances, self worth, and family support.
Timepoint [1] 4822 0
Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.
Primary outcome [2] 4823 0
Hospital Anxiety Depression Scale
Timepoint [2] 4823 0
Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.
Primary outcome [3] 4824 0
Bakas Caregiving Outcomes Scale -measures changes as a result of caregiving and is sensitive enough to detect differences among treatment groups in an intervention study.
Timepoint [3] 4824 0
Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.
Secondary outcome [1] 8146 0
Semi structured interview: the informal carers be given the opportunity to reflect on and discuss their caregiving experience in a semi-structured interview which will provide a more sensitive and deeper understanding of their caregiving experience.
Timepoint [1] 8146 0
12 months after care recipient randomised

Eligibility
Key inclusion criteria
Nominated, unpaid, informal carer of the care recipient of the Frailty Intervention Trial - FIT (ACTRN12608000250336)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Paid carers

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3930 0
Government body
Name [1] 3930 0
National Health and Medical Research Council
Country [1] 3930 0
Australia
Primary sponsor type
Individual
Name
Christina Aggar
Address
Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050
Country
Australia
Secondary sponsor category [1] 3524 0
Individual
Name [1] 3524 0
Professor Ian Cameron
Address [1] 3524 0
Royal Rehabilitation Studies Unit
PO Box 6 Ryde NSW 1680
Country [1] 3524 0
Australia
Other collaborator category [1] 431 0
Individual
Name [1] 431 0
Dr Susan Ronaldson
Address [1] 431 0
Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050
Country [1] 431 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5995 0
Harbour HREC Northern Sydney Central Coast Health
Ethics committee address [1] 5995 0
The Research Office
Level 4, Vindin House
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 5995 0
Australia
Date submitted for ethics approval [1] 5995 0
Approval date [1] 5995 0
08/05/2008
Ethics approval number [1] 5995 0
0709-191M

Summary
Brief summary
This is a substudy of the Frailty Intervention Trial - FIT (ACTRN12608000250336). Please refer to ACTRN12608000250336 for a brief summary of the FIT.

Informal support is an important part of the total care provided to frail older people and essential to the implementation of patient interventions. However, the examination of informal carers’ experience of a patient intervention is rarely measured. Informal carer experience is an important consideration, particularly in terms of them maintaining their role and quality of care for the frail older person.

The aim of this cohort sub study is to compare the effects of a multidisciplinary frailty intervention to usual care of a frail older person living in the community on informal carers’ experience of caregiving.
An informal carer is a person who provides unpaid care to a family member or friend who needs help in their daily activities. This ranges from supervision to assistance with personal care, mobility and communication, through to emotional support and practical and financial assistance. Informal carers are key players or partners in the caregiving process and so a concern for their well-being is of importance, particularly in terms of them maintaining their role and quality of care for the frail older patient. As the population ages, the role of the informal carer will become more significant and providing them with appropriate support will be vital.

Informal carers of the participants in the Frailty Intervention Trial (FIT)(ACTRN12608000250336) will be invited to participate. A background questionnaire delivered at baseline will determine sociodemographic characteristics, caregiving tasks and care duration. The impact of the Frailty Intervention Trial (FIT) (ACTRN12608000250336) on informal carer’s experience will be measured using three validated carer assessment tools at baseline, 6 months and 12 months. A follow-up measure will also be gathered at 15-18 months. The informal carers will also be given the opportunity to discuss their caregiving experience in a semi-structured interview at 12 months after the baseline questionnaire.

The primary objective is to evaluate the impact of The Frailty Intervention (FIT) on informal carers’ positive and negative aspects of caregiving. The secondary objective is to obtain a more sensitive and deeper understanding of the informal carers’ experience via a semi-structured interview. Evaluation of the impact of the Frailty Intervention Trial (FIT)(ACTRN12608000250336) on informal carers’ experience will increase our understanding of aspects of their caregiving by providing insight into carers’ perspectives, highlighting complexities and daily realities of care. In addition, it will provide us with information on how informal carers may be integrated more effectively into the implementation of frailty interventions for older people.
Trial website
This is a substudy of the FITstudy. The website is http://www.rehab.usyd.edu.au/tie/fit
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28976 0
Address 28976 0
Country 28976 0
Phone 28976 0
Fax 28976 0
Email 28976 0
Contact person for public queries
Name 12133 0
Christina Aggar
Address 12133 0
Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050
Country 12133 0
Australia
Phone 12133 0
0414 754 705
Fax 12133 0
Email 12133 0
[email protected]
Contact person for scientific queries
Name 3061 0
Christina Aggar
Address 3061 0
Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050
Country 3061 0
Australia
Phone 3061 0
0414 754 705
Fax 3061 0
Email 3061 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
EmbaseResidential respite care is associated with family carers experiencing financial strain.2014https://dx.doi.org/10.1111/j.1741-6612.2012.00637.x
N.B. These documents automatically identified may not have been verified by the study sponsor.