ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000242527

Ethics application status

Approved

Date submitted

2/06/2006

Date registered

15/06/2006

Date last updated

14/03/2008

Type of registration

Prospectively registered

Titles & IDs

Public title

Physical activity uptake, adherance and effects among home care clients.

Scientific title

Physical activity uptake, adherance and health-related quality of life among home care clients.

Universal Trial Number (UTN)

Trial acronym

HACC-ASM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Not a disease specific study. Participants are frail or elderly people with physical function impairment necessitating home based assistance with self-care or house care.

Condition category

Condition code

Public Health

Other public health

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Tailored physical activity plan for up to daily intervention for 6 months (26 weeks). Intervention will occur between 1 and 7 times per week. The length and frequency of the intervention will be tailored to the participants' abilities. Fitter participants will engage in longer or more frequent interventions. There is no control group. The study is a single group design. Participants will act as their own controls. All changes in primary and secondary outcomes will be calculated as changes from baseline data.

Intervention code [1]

Lifestyle

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Health-related quality of life (physical function, social function, mental health, perceived wellbeing) measured using the Stanford Health Assessment Questionnaire (HAQ) or the Medical Outcomes Study 36-Item health survey (SF-36)

Timepoint [1]

Measured at baseline, 3 months (13 weeks) and 6 months (26 weeks)

Secondary outcome [1]

Readiness to adopt physical activity / exercise, motivations towards physical activity / exercise, and adherance to the physical activity plan will be measured using the Stages of Change Questionnaire (Exercise, continuous measure).

Timepoint [1]

All outcomes will be measured at baseline, 3 months (13 weeks) and 6 months (26 weeks).

Eligibility

Key inclusion criteria

Receiving home care through one of three local government areas (City of Maribyrnong, City of Brimbank, Shire of Melton).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Cognitive impairment that prevents a person from giving voluntary informed consent to participate.

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will not be concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Purposeful sampling, home care workers will identify suitable clients for invitation into the study.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Interventions will be tailored to individual participants. All interventions will be physical activity increases over participants' baseline physical activity load.

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/08/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Human Services (Health & Ageing)

Address [1]

Victoria

Country [1]

Australia

Primary sponsor type

University

Name

Victoria University

Address

PO Box 14428 Melbourne 8001

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

City of Maribyrnong, Department of Human Services.

Address [1]

Victoria

Country [1]

Australia

Secondary sponsor category [2]

Government body

Name [2]

City of Brimbank, Department of Human Services.

Address [2]

Victoria

Country [2]

Australia

Secondary sponsor category [3]

Government body

Name [3]

Shire of Melton, Department of Human Services.

Address [3]

PO Box 21 Melton 3337

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Victoria University

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2006

Approval date [1]

Ethics approval number [1]

HRETH 06 / 105

Summary

Brief summary

In the three local government areas of Maribyrnong, Brimbank, and Melton, “home care” is available for people who are impaired in their ability to self care (cooking, dressing, bathing) or undertake domestic cleaning. Home care services are provided in clients’ homes by home care workers employed by the local government. People who request home care have their domestic care requirements determined by home care assessors, also employed by local government. Home care assessors also monitor clients’ home care needs through routine follow up checks. Home care workers and home care assessors practice a passive care model in which home care is delivered to clients without any requirement for client involvement. A drawback of this passive care model is that already functionally limited clients may have their physical capacity further reduced through dependence on other people. 

Three municipal councils, the Dept of Health and Ageing, and Victorian University Exercise Rehabilitation Unit will combine resources to develop an active service model of home care. Home care assessors and home care workers will be trained to identify physical activity need, and plan, implement and support physical activity with home care clients. Once home care workers and assessors have completed this training, home care clients will be invited to volunteer to participate in the active service model of home care. The active service model pilot will run for 6 months. During the active service model of home care, home care assessors and home care workers will interact with clients with the same frequency as in the current passive care model. As well as assessing home care requirements, home care assessors will identify physical activity needs and opportunities. Clients will participate in identifying physical activity needs, and planning physical activities that they a) want to undertake, and b) feel they can undertake with the supervision or assistance of their home care workers. An accredited exercise physiologist will be available throughout the project to support clients, home care workers, and home care assessors in constructing exercise / physical activity plans. Clients who volunteer to receive home care under this model will be asked to complete a battery of pencil and paper questionnaires at the beginning, middle, and end of 6 months. Using these questionnaires, the researchers will seek information about clients’ motivations toward physical activity, physical activity uptake, the continuation of physical activity over time (adherance), and any health effects (physical function, mental well-being, social function) of physical activity.

Trial website

Trial related presentations / publications

Cameron M, Chahine N, Selig S, Newton P. (2008) A pilot program of physical activity promotion among clients receiving home and community care (HACC): Very small increases in physical activity may offer important benefits. Australian Health Review. In press.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Melainie Cameron

Address

Victoria University
PO Box 14428
Melbourne MC 8001

Country

Australia

Phone

+61 3 99194287

Fax

+61 3 99194891

Melainie.Cameron@vu.edu.au

Contact person for scientific queries

Name

Melainie Cameron

Address

Victoria University
PO Box 14428
Melbourne MC 8001

Country

Australia

Phone

+61 3 99194287

Fax

+61 3 99194891

Melainie.Cameron@vu.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

No additional documents have been identified.

Trial Review

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Documents added manually

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