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Phase II clinical trial investigating the feasibility, acceptability, and preliminary efficacy of a Hub-and-Spoke, Peer-Led Community Aphasia Group program within a health service

Phase II Investigation of the feasibility, acceptability, and preliminary efficacy of a Hub-and-Spoke, Peer-Led Community Aphasia Group program within a health service

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000634370
Enrollment
37
Registered
2026-05-26
Start date
2024-02-19
Completion date
2024-04-08
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to investigate the acceptability, feasibility and preliminary efficacy of a Hub-and-Spoke, Peer-led communication aphasia group program in a regional health setting. A mixed-methods, waitlist control, randomised controlled trial and process evaluation was used. Participants included a minimum 12 people with aphasia and 12 close others, with each pair randomly allocated to either the treatment or control arm. By drawing on trained peers from the community the Hub-and-Spoke, Peer-led CAG model offers a way to address the specific challenges faced by people living with aphasia. Hub-and-Spoke, Peer-led CAGs hold potential to improve access to tailored community-based supports for people with chronic aphasia.

Interventions

What is the intervention This is a group-based intervention for people living with post-stroke aphasia in the community setting. Participants include people beyond 6-months post stroke aphasia, nominated close other. The program includes two separate interventions. A 12-week group program for participants with aphasia and a 3-week group program for nominated close others. Who delivers it and their relevant expertise? The community aphasia groups are facilitated by two volunteer facilitators,

What is the intervention This is a group-based intervention for people living with post-stroke aphasia in the community setting. Participants include people beyond 6-months post stroke aphasia, nominated close other. The program includes two separate interventions. A 12-week group program for participants with aphasia and a 3-week group program for nominated close others. Who delivers it and their relevant expertise? The community aphasia groups are facilitated by two volunteer facilitators, a peer with aphasia, and a community member without aphasia. The volunteer facilitators are provided with formalised and scaffolded support from a clinical hub comprised of 4-5 allied and mental health clinicians. Facilitation scaffolded support include: 1) Formal training delivered over two half-days and covering essential facilitation topics. This occurs at least two weeks prior to the delivery of the first session. Training is delivered by the Hub speech pathologist and Hub psychologist. 2) Clinicians input directly into the first four sessions of the program and assist with delivery of the group 3) Clinicians continue to consult with the volunteer facilitators over the 12-week program. - Initial consultation occurs in the week prior to delivery of the first session and immediately after. - Ongoing clinical support occurs in the form of a) The Hub-clinician obtains formal feedback from the volunteer facilitators at the end of each session, b) all Hub clinicians are available via email or phone to provide ad-hoc support on an as needs basis for the duration of the program. The peer-support close other groups are facilitated by the Hub-speech therapist and the Hub-psychologist. How it is delivered (e.g. face to face, online, group, individual)? The aphasia group intervention is delivered face-to-face in the outpatient setting of the health service. The sessions run as 12 x 2hour sessions over 12 weeks. The group intervention follows a modularised program with a different focus and objective for each session. Depending on the nature of the planned session participants are provided hard copy materials that have been designed specifically for the study. As outlined in the assessment section the volunteer facilitators maintain a participant attendance registry using an online Microsoft form which is completed immediately after session completion. Session 1- Co facilitated with Hub-speech therapist. Objective: i) Establish group rules, ii) Supporting communication Session 2- Co facilitated with Hub- psychology. Objective: i) Explore stroke experience and changes in identity Session 3- Co facilitated with Hub- occupational therapy. Objective: i) Expression through movement, art, participation Session 4- Co facilitated with Hub- Allied or mental health clinician. Objective i) Focus on health and wellbeing Session 5- Facilitators with and without aphasia, with support from Hub-speech therapy. Objective i) Group choice making, ii) plan Weeks 6-12, iii) review group processes and roles Session 6 to 11- Facilitators with and without aphasia, no hub input. Objective i) Follow plan set in Session 5 Session 12- Facilitators with and without aphasia, no hub input. Objective i) Celebrate 12-week program, ii) discuss future plans The nominated close other participant group engage in an alternate intervention over three sessions. To assist attendance and reduce burden these sessions are scheduled to occur in parallel to the first three sessions of the community aphasia group. The close other sessions run for a duration of 2-hours and close other participants are provided both hard and soft copy materials to review at home. These include the "Aphasia Handbook" published by the Australian Aphasia Association and Stroke Foundation and the Connect Communication Disability Network "Aphasia Information Pack" as well as materials designed specifically for the study. A close-other participant attendance registry is maintained using an online Microsoft form which is completed immediately after session completion. Session 1- close others attend the first community aphasia group with the members with aphasia. Objective: i) Establish relationships with broader group members, ii) Supporting communication Session 2- Facilitated by Hub-speech therapy. Objective i) Promote supportive space for sharing experiences of aphasia, ii) review/learn communication styles and strategies, iii) engage in peer support Session 3- Facilitated by Hub-psychologist. Objective i) Continue discussions of life with aphasia, ii) continue peer support, iii) strategies for maintaining wellbeing as a close other

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants with aphasia will be included if they: - have had a documented stroke resulting in aphasia - the documented stroke occurred more than 4 months prior to baseline assessment (T1) - Have a diagnosis of aphasia based on a score of less than 93.5 on the WAB-AQ assessment - Were fluent in English prior to stroke - Are 18 years or older at the time of consent - Are able to give consent with appropriate accommodations - Are able and willing to attend/ participate in baseline assessments, 12-week treatment period, post-intervention and follow-up assessment

Exclusion criteria

Participants will not be included if they: - Have had a previous neurological event/diagnosis (head injury, neurosurgery, dementia, epilepsy, progressive neurological disorder) other than stroke, - Have uncorrected sensory loss (hearing/vision) preventing participation in communication assessments and treatment group, and/or - Are unable to attend the 6-week follow-up assessments. - Have any other serious medical condition prior to their stroke including malignancies, psychiatric, behavioural or drug-dependency problems, which are likely to influence the participant's ability to cooperate or, in the opinion of the study investigator would prevent adherence to the protocol. - Self-report or untreated major depressive disorder. As the intervention is not designed to specifically treat major depressive disorder, the individual will be guided to make an appointment with their General Practioner who can make appropriate onwards referrals.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026