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Trial registered on ANZCTR


Registration number
ACTRN12615000664549
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
26/06/2015
Date last updated
9/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of three community aphasia groups for people with aphasia and their family members
Scientific title
The impacts of people with aphasia and their family members attending one of three models of community aphasia groups for living well with aphasia
Secondary ID [1] 286824 0
None
Universal Trial Number (UTN)
U1111-1170-7306
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 295203 0
Low mood/psychological distress 295204 0
Condition category
Condition code
Stroke 295452 295452 0 0
Ischaemic
Mental Health 295453 295453 0 0
Depression
Neurological 295655 295655 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group Name: Multi-disciplinary-facilitated community aphasia group.

Focus of the program: communication partner training, total communication, conversation practice, socialisation, participation in meaningful activities, identity (re)negotiation, advocacy, psychological support, information provision, family involvement, group process, home tasks, individual goals, transition goals.

Dose: 2 hour session one day per week for 12 weeks.

Mode of administration: Face to face group program

Group facilitators: Speech Pathologist and Social Worker. Aides: person with aphasia, person without aphasia. Additional speech pathologist consultancy.

Strategies to improve adherence: Home task reminders provided at the end of each week, reminder alerts where permission has been given (e.g., via phone, email, or text), weekly staff briefings and debriefings to address any participant concerns, on-call social worker available to address any participant concerns and provide support, participants invited to provide weekly feedback regarding experience of previous session

Procedures for monitoring adherence: Weekly attendance records, weekly feedback regarding completion of home tasks
Intervention code [1] 291983 0
Rehabilitation
Intervention code [2] 292148 0
Lifestyle
Intervention code [3] 292149 0
Behaviour
Comparator / control treatment
Comparator Group 1 Name: Speech-language-pathologist-facilitated community aphasia group

Focus of the program: total communication, conversation practice, socialisation, participation in meaningful activities, psychological support, information provision, group process, home tasks, individual goals.

Dose: 2 hour session one day per week for 12 weeks.

Mode of administration: Face to face group program

Group facilitators: Speech Pathologist. Aide: person without aphasia. Speech Pathologist and Social Worker consultancy.

Strategies to improve adherence: Home task reminders provided at the end of each week, reminder alerts where permission has been given (e.g., via phone, email, or text), weekly staff briefings and debriefings to address any participant concerns, on-call social worker available to address any participant concerns and provide support, weekly feedback regarding completion of home tasks and experience of sessions

Procedures for monitoring adherence: Weekly attendance records

Comparator Group 2 Name: Volunteer and peer co-facilitated community aphasia group

Focus of the program: total communication, conversation practice, socialisation, family involvement, transition goals.

Dose: 2 hour session one day per week for 12 weeks.

Mode of administration: Face to face group program

Group facilitators: person with aphasia, family member of person with aphasia/person without aphasia. Speech Pathologist and Social Worker consultancy.

Strategies to improve adherence: Weekly staff briefings and debriefings to address any participant concerns, on-call social worker available to address any participant concerns and provide support, staff to seek participant feedback regarding session experience

Procedures for monitoring adherence: Weekly attendance record
Control group
Active

Outcomes
Primary outcome [1] 295181 0
1. Assessment for Living with Aphasia

Areas of measurement:
Participants with aphasia--Living with aphasia: individual domains (aphasic impairment, participation in life situations, environmental factors, and personal factors) and composite score (quality of life/living with aphasia)

Reference:
Kagan, A., Simmons-Mackie, N., Victor, J. C., Carling-Rowland, A., Hoch, J., Huijbregts, M., Streiner, D., & Mok., A. (2013). Assessment for Living with Aphasia (2nd ed.) Aphasia Institute: Toronto.


Timepoint [1] 295181 0
4 weeks following the end of the program.
Primary outcome [2] 295182 0
2. Measure of Participation in Conversation; Measure of Skill in Conversation

Area of measurement:
Participants with aphasia (Measure of Participation)--Skills of the participant with aphasia in relation to participating in conversation (ability to interact or socially connect with his/her significant other, and to respond to and/or initiate specific content)

Family member (measure of skill)--Family member’s skill level in acknowledging and revealing the person with aphasia’s competence during conversation

References:
Kagan, A., Black, S., Duchan, J., Simmons-Mackie, N., & Square, P. (2001). Training volunteers as conversation partners using “Supported Convesation for Adult with Aphasia” (SCA): A controlled trial. Journal of Speech, Language & Hearing Research, 44(3), 624-638.

Kagan, A., Winckel, J., Black, S., Duchan, J., Simmons-Mackie, N., & Square, P. (2004). A set of observational measures for rating support and participation in conversation between adults with aphasia and their conversation partners. Topics in Stroke Rehabilitation, 11(1), 67-83.
Timepoint [2] 295182 0
4 weeks following the end of the program.
Primary outcome [3] 295183 0
Bakas Caregiving Outcomes Scale

Area of measurement: Family members--Life changes resulting from caregiving for a stroke survivor.

Reference:
Bakas, T., Champion, V., Perkins, S. M., Farran, C. J., & Williams, L. S. (2006). Psychometric testing of the revised 15-item Bakas Caregiving Outcomes Scale. Nursing Research, 55(5), 346–355.
Timepoint [3] 295183 0
4 weeks following the end of the program.
Secondary outcome [1] 314964 0
Communication Confidence Rating Scale for Aphasia

Area of measurement:
Participants with aphasia--Communication Confidence

References:
Babbitt, E. M., Heinemann, A. W., Semik, P., & Cherney, L. R. (2011). Psychometric properties of the Communication Confidence Rating Scale for Aphasia (CCRSA): Phase 2. Aphasiology, 25(6-7), 727–735.

Cherney, L. R., Babbitt, E. M., Semik, P., & Heinemann, A. W. (2011). Psychometric properties of the communication confidence rating scale for aphasia (CCRSA): Phase 1. Topics in Stroke Rehabilitation, 18(4), 352–360.
Timepoint [1] 314964 0
4 weeks following the end of the program
Secondary outcome [2] 314965 0
Group experience interview (60 minutes)

Area of measurement:
Participants with aphasia, family members, and staff--Face-to-face individual semi-structured interview regarding the experience of group participation
Timepoint [2] 314965 0
At the end of the program
Secondary outcome [3] 314966 0
Medical Outcomes Study Social Support Survey

Area of measurement:
Participants with aphasia--Perceived social support

Reference:
Sherbourne, C. D., & Stewart, A. L. (1991). The MOS social support survey. Social Science & Medicine, 32(6), 705–714.
Timepoint [3] 314966 0
4 weeks following the end of the program
Secondary outcome [4] 314967 0
Social Networks Communication Inventory

Area of measurement:
Participants with Aphasia--Social networks (types, size, frequency of contact, etc.)

Reference:
Blackstone, S. W. (2003). Social Networks: A communication inventory for individuals with complex communication needs and their communication partners. Monterey, Canada: Augmentative Communication, Inc.
Timepoint [4] 314967 0
4 weeks following the end of the program
Secondary outcome [5] 314968 0
Post-Group Experience Survey

The questionnaire has been designed specifically for this study.

Area of measurement:
Participant with aphasia and family members--feedback regarding experience of group participation (Likert-scale questionnaire)
Timepoint [5] 314968 0
At the end of the program
Secondary outcome [6] 314969 0
Post-Group Knowledge Survey

The questionnaire has been designed specifically for this study.

Area of measurement:
Participant with aphasia and family members--self-ratings of the degree of knowledge gained through group attendance (based on topics addressed) (Likert-scale questionnaire)
Timepoint [6] 314969 0
At the end of the program
Secondary outcome [7] 314970 0
Western Aphasia Battery--Revised

Area of measurement:
Participants with aphasia--Aphasic impairment (type, severity)

Reference:
Kertesz, A. (2007). Western Aphasia Battery-Revised. San Antonio: The Psychological Corporation.
Timepoint [7] 314970 0
4 weeks following the end of the program
Secondary outcome [8] 314971 0
Communication Effectiveness Index

Area of Measurement:
Participants with aphasia--Communication performance re. person with aphasia in relation to various daily activities (e.g., expressing that he/she has understood)

Reference:
Lomas, J., Pickard, L., Bester, S., Elbard, H., Finlayson, A., & Zoghaib, C. (1989). The Communicative Effectiveness Index. Journal of Speech and Hearing Disorders, 54(1), 113–124.
Timepoint [8] 314971 0
4 weeks following the end of the program
Secondary outcome [9] 314972 0
General Health Questionnaire-28 item version

Area of measurement: Family members--psychological distress/health

Reference:
Goldberg, D. P., & Hillier, V. F. (1979). A scaled version of the General Health Questionnaire. Psychological Medicine, (9), 139–145.
Timepoint [9] 314972 0
4 weeks after the end of the program
Secondary outcome [10] 314973 0
Stroke Aphasic Depression Questionnaire

Area of measurement: Participants with aphasia--depressed mood

Reference:
Sutcliffe, L. M., & Lincoln, N. B. (1998). The assessment of depression in aphasic stroke patients: The development of the Stroke Aphasic Depression Questionnaire. Clinical Rehabilitation, 12(6), 506–513.
Timepoint [10] 314973 0
4 weeks following the end of the program
Secondary outcome [11] 315318 0
Therapeutic Factors Inventory-19

Area of measurement: Experience of group process (perceived presence of ‘therapeutic factors’ within the group setting).

Reference:
Joyce, A. S., MacNair-Semands, R., Tasca, G. A., & Ogrodniczuk, J. S. (2011). Factor structure and validity of the Therapeutic Factors Inventory–Short Form. Group Dynamics: Theory, Research, and Practice, 15(3), 201–219.
Timepoint [11] 315318 0
Weeks 3, 6, 9, and 12 of the program.

Eligibility
Key inclusion criteria
Person with aphasia must have a primary communication partner (spouse or close other who either lives with the PWA or sees them at least weekly) who is able to undertake assessments as a minimum requirement (with opportunity for allocation to groups where family member attendance is either required or optional)

Person with aphasia time post-stroke equal to or greater than 12 months

Person with aphasia pre-morbid fluent speaker of English

Family member fluent speaker of English

Person with aphasia ability to reliably communicate ‘yes/no’ regardless of communication modality

Person with aphasia ability to manage toileting

Person with aphasia ability to maintain focus for two 50-minute sittings with a 20-minute break
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Person with aphasia and family member have a significant/uncorrected psychiatric (including anxiety and depression), vision, and/or hearing impairment

Person with aphasia and family member have a diagnosed cognitive deficit

Person with aphasia currently undergoing formal aphasia-specific intervention

Person with aphasia and family member currently attending a stroke or aphasia group


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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of participants needed to achieve study objectives has not been formally determined. This is an early phase study which seeks to test early-stage hypotheses based on a review of existing exploratory studies.

In order to ensure the three groups are comparable at baseline, group homogeneity will be tested in relation to the following: primary outcome measures, age (years), aphasia severity (Western Aphasia Battery-Revised Aphasia Quotient score) (Kertesz, 2007), and education (years). The Kruskal-Wallis analysis of variance (ANOVA) by ranks (H-test) is the non-parametric alternative to the one-way analysis of variance (F-test) used to test for three or more independent samples (Portney & Watkins, 2009). A significance level of .05 will be used.

Given 1) the use of a small sample size within the present study cannot automatically be considered representative of larger normal distributions and 2) the use of ordinal scale-level measurements, non-parametric statistical analyses will be conducted (Portney & Watkins, 2009). These will involve between- and within-groups analyses.

Within group: Friedman’s two-way analysis of variance by ranks

Between group: Kruskal-Wallis analysis of variance (ANOVA) by ranks (H-test)

Reference:
Portney, L. G., & Watkins, M. P. (2009). Foundations of clinical research: Applications to practice (3rd ed.). Pearson Education/Prentice Hall.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7872 0
St Joseph's Hospital - Auburn
Recruitment hospital [2] 7873 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [3] 7874 0
St George Hospital - Kogarah
Recruitment hospital [4] 7875 0
The Sutherland Hospital - Caringbah
Recruitment postcode(s) [1] 15818 0
2144 - Auburn
Recruitment postcode(s) [2] 15819 0
2112 - Ryde
Recruitment postcode(s) [3] 15820 0
2217 - Kogarah
Recruitment postcode(s) [4] 15821 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 291372 0
Government body
Name [1] 291372 0
Australian Research Council
Address [1] 291372 0
Level 2, 11 Lancaster Place
Canberra Airport ACT 2609
AUSTRALIA
Country [1] 291372 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Miranda Rose
Address
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora VIC 3086
Australia
Country
Australia
Secondary sponsor category [1] 290051 0
Individual
Name [1] 290051 0
Professor Leanne Togher
Address [1] 290051 0
Department of Speech Pathology, Faculty of Health Sciences, University of Sydney, Cumberland Campus C42 75 East Street Lidcombe NSW 2141
Country [1] 290051 0
Australia
Other collaborator category [1] 278487 0
Individual
Name [1] 278487 0
Professor Jacinta Douglas
Address [1] 278487 0
School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora VIC 3086
Australia
Country [1] 278487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292930 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 292930 0
La Trobe University
Bundoora VIC 3086
Ethics committee country [1] 292930 0
Australia
Date submitted for ethics approval [1] 292930 0
Approval date [1] 292930 0
09/04/2015
Ethics approval number [1] 292930 0
15-008
Ethics committee name [2] 294943 0
St Vincent's Health
Ethics committee address [2] 294943 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [2] 294943 0
Australia
Date submitted for ethics approval [2] 294943 0
03/08/2015
Approval date [2] 294943 0
06/10/2015
Ethics approval number [2] 294943 0
15/175

Summary
Brief summary
The aim of the study is to compare the efficacy of three models of community aphasia groups for participants with aphasia and their nominated family members.

Outcomes for people with aphasia will be measured in relation to each domain of the World Health Organisation (WHO) International Classification of Functioning, Disability, and Health (WHO, 2001): impairment, activity & participation, personal factors, and environmental factors. Quality of life and participant experience of the program will be additional outcome areas of interest. Outcomes for family members will relate to caregiving, psychological health, supported conversation skill, and participant experience of the program.

Hypotheses:

1) Each of the three community aphasia groups will lead to positive outcomes for all people with aphasia at the end of participation in at least one area of outcome measurement,

2) People with aphasia attending the treatment group (known as multidisciplinary-facilitated community aphasia group, or MD-CAG) will show greater gains than people with aphasia attending either of the two active comparison groups,

3) The gains made by people with aphasia attending MD-CAG will be maintained or will increase further 4-6 weeks after the end of participation,

4) Family members attending MD-CAG and one of the active comparison groups (known as volunteer and peer-facilitated community aphasia group, or VP-CAG), will show gains in at least one area of outcome measurement at the end of participation,

5) Family members of people with aphasia attending MD-CAG will show greater gains than family members of people with aphasia attending either of the two comparison groups, and

6) The gains made by family members will be maintained or will increase further 4-6 weeks after the end of participation.


Reference:
World Health Organisation. (2001). International Classification of Functioning, Disability, and Health. Geneva, Switzerland: World Health Organisation.
Trial website
Trial related presentations / publications
Attard, M., Loupis, Y., Togher, L, & Rose, M. The efficacy of an inter-disciplinary community aphasia group for living well with aphasia. Aphasiology (early online) http://dx.doi.org/10.1080/02687038.2017.1381877
Attard, M., Loupis, Y., Togher, L, & Rose, M. Experiences of people with severe aphasia and spouses attending an interdisciplinary community aphasia group. Submitted manuscript under review.
Attard, M., Loupis, Y., Togher, L, & Rose, M. Staff experiences of an interdisciplinary community aphasia group. Submitted manuscript under review.
Attard, M., Loupis, Y., Togher, L., & Rose, M. (2017). Interdisciplinary Community Aphasia Group facilitator program manual. Melbourne, Australia: La Trobe University. Open access available from: http://aphasia.community/resources/resources-for-aphasia- groups
Lanyon, L., Attard, M., Togher, L., Worrall, L., & Rose, M. (June 2017). A
metasynthesis of the community aphasia group qualitative and quantitative evidence. Australasian Society for the Study of Brain Impairment 40th Annual Brain Impairment Conference, Melbourne, Australia. (Paper).
Attard, M., Loupis, Y., Togher, L., & Rose, M. (June 2017). Recent pilot evidence: Community aphasia group efficacy. Australasian Society for the Study of Brain Impairment 40th Annual Brain Impairment Conference, Melbourne, Australia. (Paper).
Attard, M., Loupis, Y., Togher, L., Worrall., L., & Rose, M. (May 2017). Implementing Effective Community Aphasia Groups in Your Workplace. Speech Pathology Australia Conference, Sydney, Australia. (Workshop).
Lanyon, L., Attard, M., Togher, L., Worrall, L., & Rose, M. (March 2017). Translating results of community aphasia group research into practice. St Vincent’s Hospital Sub Acute Seminar, Melbourne, Australia. (Paper).
Attard, M., Lanyon, L., Togher, L., Worrall, L., & Rose, M. (December 2016). Community Aphasia Group Efficacy: A summary of qualitative findings. 17th International Aphasia Rehabilitation Conference, London, UK. (Paper).
Attard, M., Rose, M., Lanyon, L. & Togher, L. (December 2016). What are the key components of successful Community Aphasia Groups? 17th International Aphasia Rehabilitation Conference, London, UK. (Round table parallel session).
Attard, M., Togher, L., & Rose, M. (December 2016). A Phase I Clinical Trial of a Community Aphasia Group: Preliminary results. 17th International Aphasia Rehabilitation Conference, London, UK. (Poster).
Attard M., Rose, M., Togher, L., & Loupis, Y. (October 2016). A detailed program model for a Community Aphasia Group: Results from a phase I clinical trial. Aphasiology Symposium of Australia, Adelaide, Australia. (Paper).
Lanyon, L., Attard, M., Loupis, Y., Togher, L., Worrall, L., & Rose, M. (September
2016). Community Aphasia Groups: A clinic-ready model of service. La Trobe
University Research Showcase, Melbourne, Australia. (Poster).
Attard M., Togher, L., Rose, M. (August 2016). A detailed program model for a
Community Aphasia Group: Preliminary results for a Phase I clinical trial. Smart Strokes
Conference, Canberra, Australia. (Poster).
Attard, M., Lanyon, L., Togher, L., & Rose, M. (2015). Consumer perspectives on community aphasia groups: A narrative literature review in the context of psychological well-being. Aphasiology, 29(8), 983-1019.
Attard, M., Rose, M., & Togher, L. (May 2015). Comparing three community aphasia
groups: Method for non-randomised controlled trial. Speech Pathology Australia:
Canberra, Australia. (Poster).
Attard, M., Rose, M., & Togher, L. (April 2015). Community aphasia groups and living
well with aphasia: Update on research. Stroke Recovery Association of NSW & Aphasia NSW State Conference: Sydney, Australia. (Paper).
Public notes
Attachments [1] 475 475 0 0

Contacts
Principal investigator
Name 57662 0
A/Prof Miranda Rose
Address 57662 0
Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora VIC 3086
Australia
Country 57662 0
Australia
Phone 57662 0
+61394792088
Fax 57662 0
Email 57662 0
m.rose@latrobe.edu.au
Contact person for public queries
Name 57663 0
Ms Michelle Attard
Address 57663 0
Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora VIC 3086
Australia
Country 57663 0
Australia
Phone 57663 0
+61421227785
Fax 57663 0
Email 57663 0
m.attard@latrobe.edu.au
Contact person for scientific queries
Name 57664 0
A/Prof Miranda Rose
Address 57664 0
Discipline of Speech Pathology, School of Allied Health, College of Science Health and Engineering
La Trobe University, Bundoora VIC 3086
Australia
Country 57664 0
Australia
Phone 57664 0
+61394792088
Fax 57664 0
Email 57664 0
m.rose@latrobe.edu.au

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Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary