Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000209998
Ethics application status
Approved
Date submitted
15/01/2020
Date registered
20/02/2020
Date last updated
1/05/2024
Date data sharing statement initially provided
20/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising mental health and wellbeing after post-stroke aphasia
Scientific title
Optimising mood and wellbeing with aphasia after stroke: a feasibility study of PRevention Intervention and Support in Mental health (PRISM) via telerehabilitation.
Secondary ID [1] 300270 0
Nil
Universal Trial Number (UTN)
Trial acronym
Aphasia PRISM
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Post-stroke aphasia 315848 0
Condition category
Condition code
Stroke 314130 314130 0 0
Ischaemic
Stroke 314131 314131 0 0
Haemorrhagic
Neurological 314236 314236 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aphasia and communication support with self-selection of 1 of 3 psychological therapies: behavioural activiation; problem-solving therapy; or relaxation therapy.
The therapy will include the following: Participants will be provided with therapy worksheets for use in therapy session and home practice. Intervention providers will be provided with a therapy manual which includes instructions and therapy content for each therapy session.
Procedures include:
Behavioural activation: 7 x individual therapy sessions (in person or via telerehabilitation for people living in regional/rural areas) covering following themes:
-Identifying meaningful activities
-Structuring and scheduling activities
-Consistent daily activation
-Overcoming barriers
Problem-solving therapy: 7 x individual therapy sessions (in person or via telerehabilitation for people living in regional/rural areas) covering following themes:
-Identifying problems
-Listing solutions
-Potential consequences
-Best strategies
-Plan actions, implement plan and review results
Relaxation therapy: 7 x individual therapy sessions (preferably face to face with clinician or via phone/telehealth with clinician if unable to attend in person for up to two sessions) covering following themes:
-Explaining the relaxation response
-How & when to use relaxation exercises
-Practice of strategies (e.g., breathing & how to tense and relax muscles throughout the body)
-Planning to do relaxation exercises regularly and independently
- each of the procedures, activities, and/or processes used, including any enabling or support activities;
Intervention provider will be a qualified stroke health professional (Grade 1,2 or 3 clinician and experience with managing at least one person with aphasia in past 12 months). They will be trained by the research team in supported conversation for adults with aphasia (SCA) and all therapy types (behavioural activation; problem solving; relaxation therapy). Supervision will be available from senior allied health team members/managers and/or medical staff in the clinical setting as required. The research team will offer regular supervision and support to the intervention providers as required (composed of psychologists and speech pathologists).
Mode of delivery: individual sessions and in person or via telerehabilitation for people living in regional/rural areas.
Intervention will be delivered 1 x session per week (30-60 mins) for 7-8 week duration.
The intervention will occur at community centre or participant's home (if in person) or via telerehabilitation for those living in regional/rural areas.
Intervention providers will keep a therapy log sheet and video-record up to 2 therapy sessions per participant to monitor intervention fidelity.

'Attention' control arm will include stroke health information (choice of 6 out of 9 topics e.g., high blood pressure, cholesterol, physical activity and nutrition). The content will be presented by a stroke allied health professional using study-specific videos and written information using aphasia-friendly format (content acknowledges Stroke Foundation for information from their website as source of information adapted for this study https://strokefoundation.org.au/). The videos and written information aren't available to share publicly due to the need to test acceptability in this research. All aspects of the attention control sessions will be similar in conditions as the intervention arm (except for the content). That is, the following will apply to the attention control group:
Mode of delivery of sessions: 7 individual sessions in person / via telerehabilitation for people living in regional / rural areas
Frequency of sessions: 1 x session per week (30-60 mins) for 7 weeks, final session summarises the 6 previous sessions
Location of the sessions: via telerehab from home or in person at clinic in health network
Monitor of adherence/fidelity: Intervention providers will keep a therapy log sheet (planned versus implemented components of session) and liaise with primary researcher if any issues in facilitating sessions via meetings (phone, videoconference).
Aspects of the 'attention' control arm are similar to the intervention, however content will involve stroke information provision not psychological therapy.
Intervention code [1] 316546 0
Rehabilitation
Intervention code [2] 316629 0
Treatment: Other
Comparator / control treatment
Attention control - stroke health information

Attention' control arm will include stroke health information (choice of 6 out of 9 topics e.g., high blood pressure, cholesterol, physical activity and nutrition). The content will be presented by a stroke allied health professional using study-specific videos and written information using aphasia-friendly format (content acknowledges Stroke Foundation for information from their website as source of information adapted for this study https://strokefoundation.org.au/). The videos and written information aren't available to share publicly due to the need to test acceptability in this research. All aspects of the attention control sessions will be similar in conditions as the intervention arm (except for the content). That is, the following will apply to the attention control group:
Mode of delivery of sessions: 7 individual sessions in person / via telerehabilitation for people living in regional / rural areas
Frequency of sessions: 1 x session per week (30-60 mins) for 7 weeks, final session summarises the 6 previous sessions
Location of the sessions: via telerehab from home or in person at clinic in health network
Monitor of adherence/fidelity: Intervention providers will keep a therapy log sheet (planned versus implemented components of session) and liaise with primary researcher if any issues in facilitating sessions via meetings (phone, videoconference).
Aspects of the 'attention' control arm are similar to the intervention, however content will involve stroke information provision not psychological therapy.
Control group
Active

Outcomes
Primary outcome [1] 322518 0
Acceptability of intervention to participants with aphasia - rating out of 10 of individual sessions/overall program; topic guide questions in qualitative interview
Timepoint [1] 322518 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [1] 379644 0
Composite secondary outcome - Recruitment and sampling through:
Recruitment rate per week (frequency of participants recruited per week)
barriers to recruitment (study specific survey and qualitative interviews with health professionals)
number of eligible participants (including proportion of eligible participants recruited) (percentage of proportion of those eligible and those who consent to participate).
Timepoint [1] 379644 0
Baseline
Secondary outcome [2] 379645 0
Composite secondary outcome - Data collection procedures and outcome measures through:
completion rates of outcome measures at time points (percentage of proportion of participants who complete outcome measures)
assessment duration (mean duration in minutes of assessment at pre, immediately post and follow-up)
experiences and preferences of assessments by participants (qualitative interview)
Timepoint [2] 379645 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [3] 379646 0
Composite secondary outcome - Resource and ability to manage and implement through:
Acceptability of intervention to stroke health professionals using rating out of 10 and questionnaire items of usefulness (study specific rating tool and qualitative interview)
Experiences, barriers and facilitators of the recruitment, training, content and delivery of intervention reported by stroke health professionals (in semi-structured interviews)
Scores on a study specific survey Likert scale (knowledge and skills) reported by stroke health professionals
Fidelity monitoring of log sheets; sample of video-recorded therapy sessions.
Timepoint [3] 379646 0
Pre-post training (knowledge and skills of health professionals); during intervention and post-intervention (fidelity monitoring) and 1 to 6 weeks post intervention (qualitative interviews).
Secondary outcome [4] 379659 0
Stroke Aphasic Depression Questionnaire-10 (SADQ-10) (completed by family member);








Timepoint [4] 379659 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [5] 380185 0
Behavioural Outcomes of Anxiety (BOA) (completed by family member);
Timepoint [5] 380185 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [6] 380186 0
Stroke and Aphasia Quality of Life scale-39;
Timepoint [6] 380186 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [7] 380187 0
Communication Confidence Rating Scale;
Timepoint [7] 380187 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.
Secondary outcome [8] 380188 0
Warwick Edinburgh Wellbeing Scale
Timepoint [8] 380188 0
Baseline, immediately post-intervention and 3 months and 6 months (rural/regional dwellers only) follow up.

Eligibility
Key inclusion criteria
1) Adults aged 18 years or over and diagnosed with aphasia due to stroke
Subclinical/low symptoms of depression/anxiety: i.e. Stroke Aphasic Depression Questionnaire-10 (SADQ) score of equal to or less than 8 (community version) or equal to or less than 12 (hospital version) and Behavioural Outcomes of Anxiety score of equal to or less than 17. 2) Adequate hearing, vision skills and English skills to participate in intervention as judged by stroke health professional
3) Up to 5 years post-stroke and aphasia onset
4) Capacity to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Concomitant progressive neurological disorder (e.g. dementia)
2) Mental health illness or above threshold symptoms of depression/anxiety: i.e. Stroke Aphasic Depression Questionnaire-10 (SADQ) score of equal to or > 8 (community version) or equal to or > 12 (hospital version) and Behavioural Outcomes of Anxiety score of equal to or more than > 17.
3) Participant in other aphasia or psychological care/mental health study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation and assignment of sequence using computer software by independent person external to the project (site remote from trials location).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised blocked and stratified randomisation (treatment and control group; sites and aphasia severity).
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
Up to 30 participants can complete the feasibility study with resources allocated. Sampling for maximum variation of participants across 3 health networks (metropolitan and regional/rural) as per characteristics of aphasia severity (mild, mod and severe) and gender (male and female).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2021
Actual
14/07/2022
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
39
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15622 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 26503 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [3] 26504 0
Echuca Regional Health - Echuca
Recruitment postcode(s) [1] 29024 0
3168 - Clayton
Recruitment postcode(s) [2] 42543 0
3550 - Bendigo
Recruitment postcode(s) [3] 42544 0
3564 - Echuca

Funding & Sponsors
Funding source category [1] 304693 0
Charities/Societies/Foundations
Name [1] 304693 0
Speech Pathology Australia
Country [1] 304693 0
Australia
Funding source category [2] 316425 0
Charities/Societies/Foundations
Name [2] 316425 0
Stroke Foundation
Country [2] 316425 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Kingsbury Drive
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 305005 0
Hospital
Name [1] 305005 0
Monash Health
Address [1] 305005 0
Clayton Rd
Clayton VIC 3168
Country [1] 305005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305113 0
Monash Health
Ethics committee address [1] 305113 0
Ethics committee country [1] 305113 0
Australia
Date submitted for ethics approval [1] 305113 0
22/01/2020
Approval date [1] 305113 0
02/03/2020
Ethics approval number [1] 305113 0
HREC/60654/MonH-2020-204137

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

Contacts
Principal investigator
Name 99310 0
Dr Caroline Baker
Address 99310 0
Monash Health, Speech Pathology Department, Kingston Centre 400 Warrigal Rd Cheltenham Victoria 3192.
Country 99310 0
Australia
Phone 99310 0
+61 0400 369 963
Fax 99310 0
Email 99310 0
[email protected]
Contact person for public queries
Name 99311 0
Caroline Baker
Address 99311 0
Monash Health, Speech Pathology Department, Kingston Centre 400 Warrigal Rd Cheltenham Victoria 3192.
Country 99311 0
Australia
Phone 99311 0
+61 400368963
Fax 99311 0
Email 99311 0
[email protected]
Contact person for scientific queries
Name 99312 0
Caroline Baker
Address 99312 0
Monash Health, Speech Pathology Department, Kingston Centre 400 Warrigal Rd Cheltenham Victoria 3192.
Country 99312 0
Australia
Phone 99312 0
+61 0400 368 963
Fax 99312 0
Email 99312 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
Not intended for wider use beyond current study as per ethics application.


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.