Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000994088
Ethics application status
Approved
Date submitted
24/08/2010
Date registered
16/11/2010
Date last updated
16/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving opportunities for engagement for hospital inpatients with Huntington's Disease
Scientific title
Do Huntington's Disease inpatients in a subacute neurological ward who receive Diversional Therapy, compared to those you receive normal ward care, have an enhanced experience during their hospital admission?
Secondary ID [1] 252543 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's Disease 258024 0
Condition category
Condition code
Neurological 258191 258191 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 258797 258797 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ward-based Diversional Therapy program.
A Diversional Therapist will be employed 6 hours/day for 4 days/week to provide individual and group Diversional Therapy sessions, for a period of 6 months.
Intervention code [1] 257067 0
Rehabilitation
Comparator / control treatment
Normal ward care, no Diversional Therapy.
Data will be collected from interviews with patients' families, staff questionnaires and behavioural mapping, during a one month period prior to the commencement of the Diversional Therapist.
Control group
Historical

Outcomes
Primary outcome [1] 259049 0
Interviews with families will be recorded, transcribed and the data analysed for themes.
Patient questionnaires contain Likert scales as well as open ended questions.
Timepoint [1] 259049 0
Baseline data will be collected in the month before the Diversional Therapist starts.
'Post' data will be collected after the Diversional Therapy program has been operating for one month. There will be further data collection during the period of the Diversional Therapy program, and at its completion.
Secondary outcome [1] 265311 0
Behavioural mapping of Huntington's Disease patients activities and interactions on a subacute neurological ward.
The behavioural mapping will generate data that can be collated into frequencies of observations in various categories.
Timepoint [1] 265311 0
Baseline data will be collected in the month before the Diversional Therapist starts.
'Post' data will be collected after the Diversional Therapy program has been operating for one month.
Secondary outcome [2] 265312 0
Staff attitudes to caring for patients with Huntington's Disease (HD) on a subacute neurological ward, using interviews and questionaires.
Interviews with staff will be recorded, transcribed and the data analysed for themes.
Staff questionnaires contain Likert scales as well as open ended questions.
Timepoint [2] 265312 0
Baseline data will be collected in the month before the Diversional Therapist starts.
'Post' data will be collected after the Diversional Therapy program has been operating for one month. There will be further data collection during the period of the Diversional Therapy program, and at its completion.

Eligibility
Key inclusion criteria
Patients with the diagnosis of Huntington's Disease admitted to the ward during the period of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients (or their next of kin) who do not give consent to participate will be excluded from the study.

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)
This is a time-based trial. All patients admitted in the pre-intervention period will be in the Control group and patients admitted during the Intervention period will be in the Intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257512 0
Charities/Societies/Foundations
Name [1] 257512 0
Myer Foundation and Sidney Myer Fund
Country [1] 257512 0
Australia
Funding source category [2] 257527 0
Charities/Societies/Foundations
Name [2] 257527 0
Lord Mayor Charitable Foundation
Country [2] 257527 0
Australia
Primary sponsor type
Hospital
Name
Calvary Health Care Bethlehem
Address
476 Kooyong Rd
Caulfield
Melbourne, Vic 3162
Country
Australia
Secondary sponsor category [1] 256756 0
None
Name [1] 256756 0
Address [1] 256756 0
Country [1] 256756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259557 0
Calvary Health Care Bethlehem Research and Ethics Committee
Ethics committee address [1] 259557 0
Ethics committee country [1] 259557 0
Australia
Date submitted for ethics approval [1] 259557 0
Approval date [1] 259557 0
10/08/2010
Ethics approval number [1] 259557 0

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

Contacts
Principal investigator
Name 31556 0
Address 31556 0
Country 31556 0
Phone 31556 0
Fax 31556 0
Email 31556 0
Contact person for public queries
Name 14803 0
Karol Connors
Address 14803 0
Calvary Health Care Bethlehem
476 Kooyong Rd
Caulfield
Melbourne, Vic 3162
Country 14803 0
Australia
Phone 14803 0
+61 3 9595 3441
Fax 14803 0
Email 14803 0
karolc@bethlehem.org.au
Contact person for scientific queries
Name 5731 0
Karol Connors
Address 5731 0
Calvary Health Care Bethlehem
476 Kooyong Rd
Caulfield
Melbourne, Vic 3162
Country 5731 0
Australia
Phone 5731 0
+61 3 9595 3441
Fax 5731 0
Email 5731 0
karolc@bethlehem.org.au

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.