Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12615001024538 |
Date of registration:
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01/10/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Using telehealth for social communication skills training for people with traumatic brain injury and their carers
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Scientific title:
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Do people with traumatic brain injury and their carers receive equal benefit from Skype-based intervention compared to in-person intervention in terms of change in communication skills? |
Date of first enrolment:
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27/01/2015 |
Target sample size:
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36 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12615001024538.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Mrs Rachael Rietdijk
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Address:
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Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Australia |
Telephone:
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+61402159516 |
Email:
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rman7827@uni.sydney.edu.au |
Affiliation:
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Name:
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Mrs Rachael Rietdijk
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Address:
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Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Australia |
Telephone:
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+61402159516 |
Email:
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rman7827@uni.sydney.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Participants with TBI must:
(1) Have a moderate-severe TBI at least 6 months previously defined as a score on the Glasgow Coma Scale (GCS) of 9-12 (moderate) 8 or less (severe) and/or a period of Post Traumatic Amnesia (PTA) of 1-24 hours (moderate) more than 24 hours (severe),
(2) Be discharged or partially discharged from hospital, and able to spend time at home on a regular basis
(3) Have significant social communication skills deficits as identified by brain injury staff (or for self-referred participants, as observed by two independent speech pathologists using Prutting’s pragmatic protocol)
(4) Have a communication partner with whom they interact regularly
(5) Have a computer with internet connection at their home
(6) Have adequate English proficiency for completing assessment tasks without the aid of an interpreter.
Communication partners must:
(1) Interact with the person with TBI on a regular basis
(2) Have adequate English proficiency for completing assessment tasks without the aid of an interpreter
Exclusion criteria: Participants with TBI must not have:
(a) aphasia of a severity which prevents any participation in conversation
(b) severe amnesia which would prevent participants from providing informed consent, as determined by the local neuropsychologist
(c) dysarthria of a severity which would significantly affect intelligibility to an unfamiliar listener
(d) drug or alcohol addiction, or active psychosis
(e) co-occurring degenerative neurological disorder
Communication partners must not have:
(a) Sustained a brain injury
(b) Have a known psychiatric history
Age minimum:
16 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Physical Medicine / Rehabilitation - Speech therapy
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Traumatic brain injury; Traumatic brain injury
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Intervention(s)
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Ten session, manualised communication skills program (TBIconneCT) involving education and video-based feedback to identify and develop use of positive conversation skills by the person with TBI and positive support skills by the communication partner (family member, friend, carer). Participants allocated to the telehealth group will receive all training sessions via Skype video sessions. Sessions are 1.5 hour duration and conducted weekly over ten weeks. Sessions are conducted by a speech pathologist. Intervention adherence will be monitored via a log of completed sessions, and an audit of a sample of sessions to check adherence to a checklist of intervention components.
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Primary Outcome(s)
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Measure of Support in Conversation: Level of skill of the partner in providing conversational support to the person with TBI, as assessed by an independent observer[Immediately post-intervention and 3 months post-intervention]
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Secondary Outcome(s)
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Participation Assessment with Recombined Tools (Objective): A measure of participation across a range of areas of social and community life, as reported by the person with TBI[Immediately post-intervention and 3 months post-intervention]
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Bond and Godfrey conversation scales: Overall quality of conversation in terms of how appropriate, effortful, interesting and rewarding the interaction is judged to be by an independent observer[Immediately post-intervention and 3 months post-intervention]
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Agnew Relationship Measure (Therapeutic alliance): A measure of the strength of client-therapist alliance, as reported by the person with TBI and their communication partner[Post-intervention]
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Quality of Life after Brain Injury scale: A measure of health-related quality of life as reported by the person with TBI[Immediately post-intervention and 3 months post-intervention]
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La Trobe Communication Questionnaire: A questionnaire about the frequency of communication problems reported by the person with TBI and their communication partner[Immediately post-intervention and 3 months post-intervention]
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Communication Confidence Rating Scale for Aphasia: Confidence in communication ability self-reported by the person with TBI[Immediately post-intervention and 3 months post-intervention]
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Measure of Participation in Conversation: Level of participation in conversation by the person with TBI, as assessed by an independent observer[Immediately post-intervention and 3 months post-intervention]
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Source(s) of Monetary Support
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The University of Sydney
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Lifetime Care and Support Authority of NSW
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Ethics review
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Status: Approved
Approval date:
Contact:
Hunter New England Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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