Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000213549
Ethics application status
Approved
Date submitted
30/05/2006
Date registered
30/05/2006
Date last updated
1/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital versus home-based pre-discharge occupational therapy consultations for older people: a pilot study
Scientific title
Occupational Therapy consultations to improve rehabilitation and reintegration back to normal living of hospitalised older people who will return to community living post-discharge.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospitalised older people who will return to community living post-discharge. 1191 0
Condition category
Condition code
Physical Medicine / Rehabilitation 1276 1276 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Home-based pre-discharge occupational therapy assessment and education: Participants will receive a single home-based occupational therapy assessment, one-on-one education about safe performance of activities in and around their home, recommendations for home modifications, and observation of use of prescribed equipment. The home visit will occur at the address that the participant is to be discharged to after hospital.
2. Hospital-based pre-discharge occupational therapy assessment and education: Participants will receive a single hospital-based occupational therapy consultation (initial assessment and interview addressing self-care, home duties, home and community mobility, social and leisure activities; observation, practice and education about safe performance where appropriate inside the hospital, and provision of equipment and information about available community services). Participants will not receive a home visit assessment from any member of staff prior to discharge.
Intervention code [1] 1077 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1724 0
Reintegration to Normal Living Index
Timepoint [1] 1724 0
Measured at baseline, and at 2-weeks, 1-month, and 2-months post-discharge
Primary outcome [2] 1725 0
Functional Independence Measure ™
Timepoint [2] 1725 0
Measured at baseline, and at 2-weeks, 1-month, and 2-months post-discharge
Secondary outcome [1] 3076 0
Performance-Oriented Mobility Assessment
Timepoint [1] 3076 0
Measured at baseline, and at 2-weeks, 1-month, and 2-months post-discharge.
Secondary outcome [2] 3077 0
EuroQoL
Timepoint [2] 3077 0
Measured at baseline, and at 2-weeks, 1-month, and 2-months post-discharge.
Secondary outcome [3] 3078 0
Falls Efficacy Scale (FES-I)
Timepoint [3] 3078 0
Measured at baseline, and at 2-weeks, 1-month, and 2-months post-discharge.

Eligibility
Key inclusion criteria
Mild or no cognitive impairment, and who are community dwelling prior to current hospital admission and plan to return to same dwelling on discharge (non-institutional).
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical contraindications that would require strict adherence to equipment recommendations.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation with opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel software was used to generate the study randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1396 0
Charities/Societies/Foundations
Name [1] 1396 0
Royal Rehabilitation Centre, Sydney
Country [1] 1396 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit, University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1228 0
University
Name [1] 1228 0
School of Biomedical and Health Sciences, University of Western Sydney
Address [1] 1228 0
Locked Bag 1797
Penrith South DC NSW 1797
Country [1] 1228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2748 0
Royal Rehabilitation Centre
Ethics committee address [1] 2748 0
Ethics committee country [1] 2748 0
Australia
Date submitted for ethics approval [1] 2748 0
Approval date [1] 2748 0
11/01/2006
Ethics approval number [1] 2748 0
05/14

Summary
Brief summary
The aim of this study is to evaluate the feasibility of a randomised controlled trial comparing two types of pre-discharge occupational therapy consultations for older adults: home-based versus hospital-based consultations. In particular the study will test the feasability of trial procedures consent rates, and the acceptability of both forms of consultation. Individuals who are aged over 65 years and living in the community prior to admission will be asked to participate. Study participants (n=10) will be randomly assigned to receive either a hospital-based or a home-based pre-discharge occupational therapy assessment and education. The home-based consultations are more time-consuming and costly than hospital-based consultations, however it is unknown if patient outcomes differ. Participants will be tested before and during the study using standardised outcome measures by a qualified occupational therapist who is blind to group allocation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35839 0
Address 35839 0
Country 35839 0
Phone 35839 0
Fax 35839 0
Email 35839 0
Contact person for public queries
Name 10266 0
Natasha Lannin
Address 10266 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre
PO Box 6
Ryde NSW 2112
Country 10266 0
Australia
Phone 10266 0
+61 2 98089236
Fax 10266 0
Email 10266 0
[email protected]
Contact person for scientific queries
Name 1194 0
Christine Lin
Address 1194 0
Rehabilitation Studies Unit
Royal Rehabilitation Centre
PO Box 6
Ryde NSW 2112
Country 1194 0
Australia
Phone 1194 0
+61 2 98089236
Fax 1194 0
Email 1194 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.