Trial Review

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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. 1219 0
Condition category
Condition code
Public Health 1303 1303 0 0
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] 1121 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1783 0
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] 1783 0
Measured at baseline, 3 months (13 weeks) and 6 months (26 weeks)
Secondary outcome [1] 3137 0
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] 3137 0
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?
No
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
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1430 0
Government body
Name [1] 1430 0
Department of Human Services (Health & Ageing)
Country [1] 1430 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428 Melbourne 8001
Country
Australia
Secondary sponsor category [1] 1258 0
Government body
Name [1] 1258 0
City of Maribyrnong, Department of Human Services.
Address [1] 1258 0
Victoria
Country [1] 1258 0
Australia
Secondary sponsor category [2] 1259 0
Government body
Name [2] 1259 0
City of Brimbank, Department of Human Services.
Address [2] 1259 0
Victoria
Country [2] 1259 0
Australia
Secondary sponsor category [3] 1260 0
Government body
Name [3] 1260 0
Shire of Melton, Department of Human Services.
Address [3] 1260 0
PO Box 21 Melton 3337
Country [3] 1260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2804 0
Victoria University
Ethics committee address [1] 2804 0
Ethics committee country [1] 2804 0
Australia
Date submitted for ethics approval [1] 2804 0
15/07/2006
Approval date [1] 2804 0
Ethics approval number [1] 2804 0
HRETH 06 / 105

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

Contacts
Principal investigator
Name 35312 0
Address 35312 0
Country 35312 0
Phone 35312 0
Fax 35312 0
Email 35312 0
Contact person for public queries
Name 10310 0
Melainie Cameron
Address 10310 0
Victoria University
PO Box 14428
Melbourne MC 8001
Country 10310 0
Australia
Phone 10310 0
+61 3 99194287
Fax 10310 0
+61 3 99194891
Email 10310 0
[email protected]
Contact person for scientific queries
Name 1238 0
Melainie Cameron
Address 1238 0
Victoria University
PO Box 14428
Melbourne MC 8001
Country 1238 0
Australia
Phone 1238 0
+61 3 99194287
Fax 1238 0
+61 3 99194891
Email 1238 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.