ANZCTR - Registration

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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

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

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]

Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.

Primary outcome [2]

Hospital Anxiety Depression Scale

Timepoint [2]

Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.

Primary outcome [3]

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]

Baseline, six and 12 months after randomisation of care recipient and 6 months post intervention cessation.

Secondary outcome [1]

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]

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]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Individual

Name [1]

Professor Ian Cameron

Address [1]

Royal Rehabilitation Studies Unit
PO Box 6 Ryde NSW 1680

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Susan Ronaldson

Address [1]

Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Harbour HREC Northern Sydney Central Coast Health

Ethics committee address [1]

The Research Office
Level 4, Vindin House
Royal North Shore Hospital
St Leonards NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/05/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Christina Aggar

Address

Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050

Country

Australia

Phone

0414 754 705

Fax

c.aggar@usyd.edu.au

Contact person for scientific queries

Name

Christina Aggar

Address

Faculty of Nursing & Midwifery
University of Sydney
(MO2) 88 Mallett Street
Camperdown 2050

Country

Australia

Phone

0414 754 705

Fax

c.aggar@usyd.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
Embase	Residential respite care is associated with family carers experiencing financial strain.	2014	https://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.

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Documents added manually

Documents added automatically