Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000499684
Ethics application status
Approved
Date submitted
19/09/2005
Date registered
23/09/2005
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Telephone versus Face to Face communication in dysphasic stroke patients
Scientific title
A comparison of face to face versus telephone communication ability in individuals with a stroke related communication disorder
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 623 0
Communication disorders 624 0
Condition category
Condition code
Stroke 696 696 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study to address whether there are differences in communication style/techniques between face-face conversation vs telephone conversations with the same communication partner.
Intervention code [1] 648 0
Rehabilitation
Comparator / control treatment
Patients provide own control as study compared telephone vs face-face communication
Control group
Active

Outcomes
Primary outcome [1] 848 0
Scoring of the 2 different conversations (telephone vs Face-face) using the 1.Boston Diagnostic Aphasia Examination scales (Profile of Speech Characteristics and Severity Rating Scale) and
2. Conversational Analysis
Timepoint [1] 848 0
.
Secondary outcome [1] 1686 0
The family perspective (ie communication partner) of the level of difficulty in each conversation using a visual analogue scale.
Timepoint [1] 1686 0
.

Eligibility
Key inclusion criteria
All consecutive stroke patients admitted to Stroke rehabilitation ward at The Princess margaret Hospital, Christchurch NZ are currently screened for communication disorder. From October 3 2005 every second patient will be requested to participate. The screening tool includes a benign question to introduce the topic of telephone communication. Patients (or their families) who provide positive responses to these telephone questions, or who report at any time in therapy, that communication over the phone is superior, will also be referred to the research project.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those unwilling to participate or who do not have a familiar communication partner available for the study.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
recruited only 4 patients due to a variety of factors with parental leave, lack of funding to do transcript analysis and change in employment of researcher
Date of first participant enrolment
Anticipated
3/10/2005
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
18/12/2006
Date of last data collection
Anticipated
18/12/2006
Actual
18/12/2006
Sample size
Target
10
Accrual to date
Final
4
Recruitment outside Australia
Country [1] 233 0
New Zealand
State/province [1] 233 0

Funding & Sponsors
Funding source category [1] 771 0
Self funded/Unfunded
Name [1] 771 0
Country [1] 771 0
Primary sponsor type
Individual
Name
Dr Carl Hanger
Address
Geriatrician, Burwood Hospital, 300 Burwood Road, Christchurch 8083, New Zealand
Country
New Zealand
Secondary sponsor category [1] 632 0
Individual
Name [1] 632 0
Ms Margaret Sargent
Address [1] 632 0
Community Service team manager
Princess Margaret Hospital
Cashmere Road,
Christchurch 8024
Country [1] 632 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2017 0
Upper South B regional Ethics Committee
Ethics committee address [1] 2017 0
[email protected]
Ethics committee country [1] 2017 0
New Zealand
Date submitted for ethics approval [1] 2017 0
Approval date [1] 2017 0
01/11/2004
Ethics approval number [1] 2017 0
CTR/04/11/227

Summary
Brief summary
Aphasia is a communication disorder that occurs following a stroke. Some families or friends of aphasic stroke patients at TPMH have spontaneously reported that their relatives communication during telephone conversations (TC) appears superior to their face to face conversations (FFC). This study seeks to determine whether this impression can be confirmed by comparing the patients communicative ability in these two settings. The study is also interested in establishing; (1) whether the familiarity (of the aphasic speaker) with their conversation partner influences the individuals communication in these settings and, (2) whether different types of aphasia alter the individuals communicative ability in these settings.There will be a minimum of one and a maximum of 10 participants. The method will be a series of single subject designs.
Each patient will represent a single case study, which can stand alone, but when sufficient cases are collected, group results will be analysed.
This is a single subject, quasi experimental ABAB paired design with each patient acting as his or her own control. The following will be analysed and compared for each patient - language impairment, communication functioning, relationship of conversation partner to participant. For each conversation, the conversation partner will be requested to indicate the level of difficulty \ ease (using a visual analogue scale) that they experienced whilst communicating with the patient. Each conversation will be for maximum of 10 minutes, but due to severity of the aphasia, it is anticipated that many conversation sets may be shorter than this.
Each study may stand alone but if/when sufficient cases are collected, group results may be analysed. The total time period for any one patient to complete all conversations is within 14 days.
Trial website
Trial related presentations / publications
Honours Thesis for Speech Language Therapist completed 31/02/2014.
No other publications have been made
Public notes

Contacts
Principal investigator
Name 35733 0
Dr H Carl Hanger
Address 35733 0
Burwood Hospital
300 Burwood Road
Christchurch 8083
Country 35733 0
New Zealand
Phone 35733 0
+64 3 3377701
Fax 35733 0
Email 35733 0
[email protected]
Contact person for public queries
Name 9837 0
Dr Dr Carl Hanger
Address 9837 0
Princess Margaret Hospital
PO Box 800
Christchurch
Country 9837 0
New Zealand
Phone 9837 0
+64 3 3377933
Fax 9837 0
Email 9837 0
[email protected]
Contact person for scientific queries
Name 765 0
Ms Ms Margaret Sargent
Address 765 0
Princess Margaret Hospital
PO Box 800
Christchurch
Country 765 0
New Zealand
Phone 765 0
+64 3 3377899
Fax 765 0
Email 765 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.