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
ACTRN12610000303044
Ethics application status
Not yet submitted
Date submitted
19/02/2010
Date registered
16/04/2010
Date last updated
16/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Communication and Environmental Control for People with Friedreich Ataxia (FA)
Scientific title
Does Communication and Environmental Control Technology Meet the Needs of People with Advanced Friedreich Ataxia ?
Secondary ID [1] 1442 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication and environmental control needs of people with Advanced Friedreich Ataxia 256853 0
Condition category
Condition code
Human Genetics and Inherited Disorders 257000 257000 0 0
Other human genetics and inherited disorders
Neurological 257324 257324 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Occupational therapist to assess individual's ability to read and write, use a computer, and operate household appliances such as doors, lights, television and music system WITH the use of alternate computer access equipment, environmental control and communication technology.
A one-off 2 hour session will be undertaken where the participant will trial the computer access and environmental control technology. An Occupational Therapist will facilitate this trial and will set up the equipment and monitor the trial. The appropriate technology will be selected based on the in-depth interview completed and the therapists assessment outlined above. The control arm outlined below will be completed first. The intervention arm will be completed on the same day after a 15 minute break.
Intervention code [1] 256047 0
Other interventions
Comparator / control treatment
Occupational therapist to assess individual's ability to read and write, use a computer, and operate household appliances such as doors, lights, television and music system WITHOUT the use of alternate computer access equipment, environmental control and communication technology.
A one off 30 min session will be completed.
Control group
Active

Outcomes
Primary outcome [1] 257900 0
To determine the communication and environmental control needs of people with Advanced FA. An in-depth interview, trial of computer access and environmental control equipment and skilled observation will be used to assess this.
Timepoint [1] 257900 0
On the same day as the intervention.
Secondary outcome [1] 263357 0
Nil
Timepoint [1] 263357 0
Nil

Eligibility
Key inclusion criteria
People with advanced FA with difficulties in reading, writing, computer access or control of home environment appliances e.g. doors, lights, TV, and their support people e.g. immediate family member, or primary carer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People under age 18 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All recruited participants will participate in the intervention. We will be comparing with and without intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256579 0
Other
Name [1] 256579 0
Drs Mary and Peter Fama
Country [1] 256579 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Ability Technology
Address
29 Frenchs Forest Rd Seaforth NSW 2029
Tel: +61 2 9907 9736
Country
Australia
Secondary sponsor category [1] 255850 0
None
Name [1] 255850 0
Address [1] 255850 0
Country [1] 255850 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258591 0
Hawkesbury Human Research Ethics Committee
Ethics committee address [1] 258591 0
Northern Sydney Central Coast Area Health Services
Area Executive Officers, Gosford Hospital, Holden Street Gosford NSW 2250.
Ethics committee country [1] 258591 0
Australia
Date submitted for ethics approval [1] 258591 0
30/09/2009
Approval date [1] 258591 0
Ethics approval number [1] 258591 0
0911-296M

Summary
Brief summary
The
project aims to:
1. Determine the communication, computer and environmental control technology
product needs for individuals with advanced FA.
2. Develop an online resource regarding equipment specific to the needs identified.
3. Prepare a funding proposal for equipment and resources not yet available.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30861 0
Address 30861 0
Country 30861 0
Phone 30861 0
Fax 30861 0
Email 30861 0
Contact person for public queries
Name 14108 0
Gemma McDonald
Address 14108 0
Ability Technology 29 Frenchs Forest Rd Seaforth NSW 2092
Country 14108 0
Australia
Phone 14108 0
+61 2 9907 9736
Fax 14108 0
Email 14108 0
[email protected]
Contact person for scientific queries
Name 5036 0
Gemma McDonald
Address 5036 0
Ability Technology 29 Frenchs Forest Rd Seaforth NSW 2092
Country 5036 0
Australia
Phone 5036 0
+61 2 9907 9736
Fax 5036 0
Email 5036 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.