Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000963921
Ethics application status
Approved
Date submitted
7/09/2011
Date registered
8/09/2011
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of tailored patient multimedia education on older patient's engagement in falls prevention strategies after hospital discharge.
Scientific title
The effect of providing tailored multimedia education in addition to usual care compared with usual care alone on older patients' engagement in falls prevention strategies after hospital discharge - a randomised controlled trial.
Secondary ID [1] 262991 0
Nil
Universal Trial Number (UTN)
U1111-1124-3232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 270720 0
Adverse events after hospital discharge 270721 0
Condition category
Condition code
Injuries and Accidents 270895 270895 0 0
Other injuries and accidents
Public Health 270896 270896 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is delivered in addition to usual care. Multimedia falls prevention education with between 2 and 4 individual health professional follow-up sessions for each patient in the week prior to hospital discharge and one follow up telephone call for each patient made in the fortnight after hospital discharge to consolidate the education. Each participant in the intervention group to receive education individually by being shown a DVD and also being given written materials with workbook. Patient receives individual tailored discussion and feedback that allow them to develop goals and strategies. Participants receive between 3 and 6 individual sessions depending on their falls risk and individual medical conditions. Personalised Telephone call counselling and feedback based on earlier goals concludes education. No group activities.
Intervention code [1] 269337 0
Prevention
Intervention code [2] 269338 0
Treatment: Other
Intervention code [3] 269339 0
Behaviour
Comparator / control treatment
Usual care of older patient at discharge including advice and discharge planning protocols at hospital
Control group
Active

Outcomes
Primary outcome [1] 279575 0
Number and amount of falls prevention strategies engaged in by participants, assessed by telephone survey
Timepoint [1] 279575 0
Baseline and 1 month after hospital discharge
Primary outcome [2] 279576 0
Participants' self perceived risk and knowledge about falls and falls prevention strategies in the period after hospital discharge assessed by face to face survey.
Timepoint [2] 279576 0
Baseline and immediately post education and prior to hospital discharge
Secondary outcome [1] 287939 0
Participants' in the intervention group - self percieved risk and knowledge about falls and falls prevention, and confidence and motivation to engage in falls prevention strategies after receiving the education, assessed with face to face survey based on the Health Belief Model
Timepoint [1] 287939 0
Baseline and immediately after the education and prior to discharge
Secondary outcome [2] 287944 0
Participants in the intervention group - rate audibility, clarity and general presentation of multimedia materials, assessed with face to face survey developed from previous trial that assessed presentation of multimedia materials.
Timepoint [2] 287944 0
Immediately after engagement with multimedia education section of the intervention

Eligibility
Key inclusion criteria
Inpatient in medical or rehabilitation ward being discharged from hospital within one week of enrollment into study
Discharged to community dwelling
Able to provide written informed consent
Speaks English as first language
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Discharge is to hostel or nursing home
Any diagnosis of cognitive impairment or confusion
Under care of palliative or mental health medical officer
Hearing impairment that precludes receiving telephone call
Re-admission to hospital within last 14 days

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients approached and written consent sought. Participants are allocated to groups in a 1:1 ratio in consecutive order after enrolment by the research assistant. The allocation is performed by the researcher who phones the co-investigator who is off site and not involved in recruitment, data collection or providing interventions. The co-investigator opens an opaque sealed envelope with the participant’s study identification number on it. The paper inside the envelope contains the group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelope order is determined by a computer generated random number sequence that is produced by a project collaborator at an external university who is not involved in recruitment, intervention or data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2012
Actual
12/04/2012
Date of last participant enrolment
Anticipated
Actual
12/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1467 0
Swan Districts Hospital - Middle Swan
Recruitment postcode(s) [1] 4458 0
6041
Recruitment postcode(s) [2] 4459 0
6054
Recruitment postcode(s) [3] 4460 0
6056
Recruitment postcode(s) [4] 4461 0
6071
Recruitment postcode(s) [5] 4462 0
6072
Recruitment postcode(s) [6] 4463 0
6076
Recruitment postcode(s) [7] 4464 0
6081
Recruitment postcode(s) [8] 4465 0
6082
Recruitment postcode(s) [9] 4466 0
6103

Funding & Sponsors
Funding source category [1] 269808 0
Charities/Societies/Foundations
Name [1] 269808 0
The Menzies Foundation
Country [1] 269808 0
Australia
Primary sponsor type
Individual
Name
Dr. Anne-Marie Hill
Address
School of Physiotherapy
University Notre Dame Australia
School of Physiotherapy
PO Box 1225 Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 268842 0
University
Name [1] 268842 0
University Notre Dame Australia
Address [1] 268842 0
PO Box 1225 Fremantle WA 6959
Country [1] 268842 0
Australia
Other collaborator category [1] 252252 0
Individual
Name [1] 252252 0
Associate Professor Christopher Beer
Address [1] 252252 0
University of Western Australia
Faculty of Medicine and Pharmacology
Centre for Health & Ageing
35 Stirling Highway Crawley WA 6009
Country [1] 252252 0
Australia
Other collaborator category [2] 277597 0
Individual
Name [2] 277597 0
Associate Professor Terry P. Haines
Address [2] 277597 0
School of Primary Health Care,
Allied Health Research Unit Kingston Centre,
Monash University,
Melbourne, Victoria, 3800, Australia
Southern Health, Victoria, Australia
246 Clayton Road
Clayton, Victoria, 3168, Australia

Country [2] 277597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271770 0
University Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 271770 0
Ethics committee country [1] 271770 0
Australia
Date submitted for ethics approval [1] 271770 0
01/10/2011
Approval date [1] 271770 0
03/11/2011
Ethics approval number [1] 271770 0
011080F
Ethics committee name [2] 271771 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [2] 271771 0
Ethics committee country [2] 271771 0
Australia
Date submitted for ethics approval [2] 271771 0
01/11/2011
Approval date [2] 271771 0
17/11/2011
Ethics approval number [2] 271771 0
2011-143
Ethics committee name [3] 271772 0
not required
Ethics committee address [3] 271772 0
Ethics committee country [3] 271772 0
Date submitted for ethics approval [3] 271772 0
Approval date [3] 271772 0
Ethics approval number [3] 271772 0

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

Contacts
Principal investigator
Name 33119 0
Dr Anne-Marie Hill
Address 33119 0
School of Physiotherapy University Notre Dame Australia PO Box 1225 Fremantle WA 6959
Country 33119 0
Australia
Phone 33119 0
+61 0894330239
Fax 33119 0
+61 0894330210
Email 33119 0
[email protected]
Contact person for public queries
Name 16366 0
Dr Anne-Marie Hill
Address 16366 0
School of Physiotherapy
University Notre Dame Australia
PO Box 1225 Fremantle WA 6959
Country 16366 0
Australia
Phone 16366 0
+61 0894330239
Fax 16366 0
+61 0894330210
Email 16366 0
[email protected]
Contact person for scientific queries
Name 7294 0
Dr. Anne-Marie Hill
Address 7294 0
School of Physiotherapy
University Notre Dame Australia
PO Box 1225 Fremantle WA 6959
Country 7294 0
Australia
Phone 7294 0
+61 0894330239
Fax 7294 0
+61 0894330210
Email 7294 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

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