Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000358448
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
21/03/2016
Date last updated
27/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an emailed questionnaire successfully ascertain information about falls in people over 60 years?
Scientific title
The Tasmanian electronic falls ascertainment tool (TASeFALL) – pilot study: Evaluating the efficacy of an email format falls questionnaire for improving response rates in older people attending a blood pressure clinic.
Secondary ID [1] 288768 0
None
Secondary ID [2] 288792 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TASeFALL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 298029 0
Condition category
Condition code
Public Health 298183 298183 0 0
Epidemiology
Injuries and Accidents 298217 298217 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: The intervention group will receive the a questionnaire about falls (type, location, time and injury) and their circumstances that will be sent by email each month (TASeFALL). The responses and number of reminder emails sent will be automatically recorded in a database. Reminder emails will be sent every 3 days.
Intervention code [1] 294209 0
Diagnosis / Prognosis
Comparator / control treatment
Control (Usual approach) group: The control group will be sent a paper-based falls questionnaire (modified version of the falls questionnaire in Lord et al Fall in Older People Cambridge Press 2004) each month asking the same questions as the email questionnaire. They will post this back each month with the daily falls calendar. Participants will be telephoned if they do not return the questionnaire or daily falls calendar. This will occur 2 weeks after the questionnaire has been sent.
Control group
Active

Outcomes
Primary outcome [1] 297688 0
Number of reminders to answer the questionnaires: Number of telephone calls (paper-based questionnaire group) or number of email reminders (TASeFALL group)
Timepoint [1] 297688 0
12 months
Secondary outcome [1] 321842 0
Cost of each method: Total costs of postage, envelopes, stationary and research assistant time will be done by review of study cost records.
Timepoint [1] 321842 0
12 months
Secondary outcome [2] 321843 0
Acceptability and usability of each method will be assessed with a modified version of the System Usability Scale
Timepoint [2] 321843 0
12 months
Secondary outcome [3] 321844 0
Response proportion = number who participated in the study/number eligible
Timepoint [3] 321844 0
After recruitment of 80 participants
Secondary outcome [4] 321845 0
Reason for non-participation=number with no email access; number with dementia; number with severe visual impairment; number refused
Timepoint [4] 321845 0
End of recruitment

Eligibility
Key inclusion criteria
>=60 years
Attending the Menzies Institute for Medical Research Blood Pressure Clinic
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Dementia (Self-reported history of dementia or less than 18/30 on the Montreal Cognitive Assessment (MOCA) – routinely obtained at the blood pressure clinic); no email access or severe visual impairment so as unable to complete a questionnaire.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Permuted block
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main outcomes of this study relate to feasibility of TASeFALL. This will be achieved by reporting the response proportion and numbers and reasons that participants were ineligible . For each group descriptive data will be used to describe participant characteristics, number of reminders required to obtain falls data, costs and participant acceptability of each method.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/04/2016
Actual
6/05/2016
Date of last participant enrolment
Anticipated
4/05/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 293133 0
Charities/Societies/Foundations
Name [1] 293133 0
Royal Hobart Hospital Research Foundation
Country [1] 293133 0
Australia
Primary sponsor type
Individual
Name
Michele Callisaya
Address
Menzies Institute for Medical Research
17 Liverpool Street
Hobart, Tasmania 7000
Country
Australia
Secondary sponsor category [1] 291928 0
None
Name [1] 291928 0
Address [1] 291928 0
Country [1] 291928 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294631 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 294631 0
Private Bag 01
Hobart Tasmania 7001
Ethics committee country [1] 294631 0
Australia
Date submitted for ethics approval [1] 294631 0
14/12/2011
Approval date [1] 294631 0
15/03/2016
Ethics approval number [1] 294631 0
H0015459

Summary
Brief summary
Over 40% of older people living in the community fall each year. In clinical practice, recent guidelines recommend that older people be regularly asked about falls and their circumstances. Ascertaining falls is also important to measure the success of any intervention.
In research settings previous studies have found that asking about falls 3- or 12-monthly results in under reporting of falls compared with a daily calendar returned monthly with telephone or paper-based questionnaire follow-up to determine the circumstances of falls. This method of a daily falls calendar and monthly follow-up by questionnaire or telephone call has been well validated and is now considered to be the gold standard in falls ascertainment.
However, this method is labour and cost intensive as every month there are postage costs, need to manually check that the calendar has been returned (previous studies have reported 30% need follow-up), telephoning to determine circumstances of falls and data or medical file entry by a research assistant or clinician. Therefore there is an important need to improve the way falls ascertainment is conducted. We aim to undertake the world first testing of a novel emailed electronic falls ascertainment tool (TASeFALL) that reminds participants to complete the electronic questionnaire, with responses automatically fed into a database or clinicians email.
Trial website
No
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 64418 0
Dr Michele Callisaya
Address 64418 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool Street
Hobart Tasmania 7000
Country 64418 0
Australia
Phone 64418 0
+61 3 6226 4785
Fax 64418 0
Email 64418 0
[email protected]
Contact person for public queries
Name 64419 0
Dr Michele Callisaya
Address 64419 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool Street
Hobart Tasmania 7000
Country 64419 0
Australia
Phone 64419 0
+61 3 6226 4785
Fax 64419 0
Email 64419 0
[email protected]
Contact person for scientific queries
Name 64420 0
Dr Michele Callisaya
Address 64420 0
Menzies Institute for Medical Research
University of Tasmania
17 Liverpool Street
Hobart Tasmania 7000
Country 64420 0
Australia
Phone 64420 0
+61 3 62264785
Fax 64420 0
Email 64420 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.