Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000270415
Ethics application status
Approved
Date submitted
27/03/2025
Date registered
6/04/2025
Date last updated
6/04/2025
Date data sharing statement initially provided
6/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercising, Socialising and Thinking – an Environmental Enrichment Model in the community (ESTEEM) After Stroke
Scientific title
The effect of the Exercising, Socialising and Thinking – an Environmental Enrichment Model in the community (ESTEEM) Program on physical function and quality of life.
Secondary ID [1] 302276 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ESTEEM After Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 319017 0
Condition category
Condition code
Stroke 316972 316972 0 0
Haemorrhagic
Stroke 316973 316973 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A wait-list randomised controlled-trial (RCT) (n=270) will be employed to test the effectiveness of the ESTEEM Program when delivered by three community-based care providers, across the Hunter New England LHD.
Stroke survivors and their carers recruited to ESTEEM at all sites will be randomly allocated to either the intervention (Program) group, or a wait-list control group.

The intervention is attending the ESTEEM Program: 150mins of activities, twice per week for 10 weeks. The ESTEEM Program is run through community based care providers at a community venue of their choice, and is delivered in a group setting with 10-12 participants per session. Each session consists of:
* 30 minutes of physical activity (for example sit-to-stand, march on the spot, toe taps),
* 30 minutes of socialising and sharing experiences over morning tea, and
* 90 minutes of creative (art-based) thinking activities (either dancing, or learning visual arts skills).
Throughout the 10 weeks, participants will be offered the opportunity to participate in both aspects of the creative thinking activities (dancing or visual arts).
All three components are run at each session and participants are encouraged to participate in all activities, though will not be forced. Each component of the Program will be delivered by an appropriately qualified professional, such as a physiotherapist for the exercise component and a qualified instructor of arts or music for the creative thinking activities. The ESTEEM Program service team will include a program coordinator to support administration and coordination of participant experience in the program.

Demographics of and the characteristics describing stroke survivor and carer stroke journeys will be collected on entry into the study (baseline). Health outcomes will be collected from consenting stroke survivors and their carers pre (baseline, 0 weeks), immediately after (post, 10 weeks) and then three months after completion of the ESTEEM Program (3 month follow-up (FU) 24 weeks). Adverse events will be monitored during time on trial for stroke survivors.
Intervention code [1] 318563 0
Treatment: Other
Intervention code [2] 318564 0
Rehabilitation
Comparator / control treatment
Stroke survivors and their carers on the ESTEEM Program waiting list will function as a control group, and will have the same health outcomes collected at baseline and after 10 weeks of receiving no intervention (while waiting for an ESTEEM Program position to become available). Once a position becomes available on the ESTEEM Program, they will be invited to transition to the intervention group and attend the ESTEEM Program. Health outcomes will be collected similarly to the intervention group: after participating in the 10week ESTEEM Program, and three months after completion of the Program (3 month follow-up, 24 weeks).
Control group
Active

Outcomes
Primary outcome [1] 325082 0
Stroke survivor physical function will be measured as a primary outcome using the Short Physical Performance Battery (SPPB).
Timepoint [1] 325082 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Primary outcome [2] 325084 0
The second primary outcome measure for stroke survivors will be quality of life (using the AQoL-8D).
Timepoint [2] 325084 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Primary outcome [3] 340971 0
Carer quality of life will be assessed using EQ5D as a primary outcome.
Timepoint [3] 340971 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Secondary outcome [1] 386806 0
Serious adverse events, including falls requiring hospitalisation or presentation to emergency will be collected as a secondary outcome. This will be collected from interviews with participant, service provider (NGO) and review of medical records to clarify any uncertainty surrounding a noted adverse event.
Timepoint [1] 386806 0
Adverse events will be recorded while the participant is involved in the project. While the participant is on Program, any event which occurs while attending the program will be reported by the program coordinator. At 10 weeks, completion of Program and 3 month follow-up, the participant will be asked if there are any adverse events to report.
Secondary outcome [2] 445288 0
Carer sense of burden will be collected as a co-primary outcome using the Modified Carer Strain Index.
Timepoint [2] 445288 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Secondary outcome [3] 445314 0
Stroke survivors fear of falling will be collected as a tertiary outcome using the Falls Efficacy Scale- International.
Timepoint [3] 445314 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Secondary outcome [4] 445645 0
Stroke survivors severity of fatigue symptoms will be collected as a tertiary outcome using the Fatigue Severity Scale.
Timepoint [4] 445645 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Secondary outcome [5] 445646 0
Health economic evaluation of the Program will be assessed using a Client Services Receipt Inventory collected in interview format with the participant, and review of participant medical records. Comparison of the intervention and waitlist-control groups will be performed.
Timepoint [5] 445646 0
This inventory will be collected at 10 weeks and up to 6 months after the baseline timepoint.
Secondary outcome [6] 445647 0
Cost effectiveness analysis will be calculated using utility data derived from the EQ-5D to calculate Quality-Adjusted Life-Years (QALY). Costs and health outcomes will be summed to determine an incremental cost-effectiveness ratio, in dollars per QALY gained. A system-level analysis of cost-offsets delivered by changes in service usage will be conducted using the Client Services Receipt Inventory 10 weeks and up to 6 months post-baseline (participant interview and review of participant medical records).
Timepoint [6] 445647 0
The EQ5D will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.
Secondary outcome [7] 445648 0
Stroke survivors degree of disability/dependence will be measured using the Modified Rankin Scale.
Timepoint [7] 445648 0
Outcome measures will be collected at baseline (0 weeks), at the completion of the 10week ESTEEM Program (10 weeks), and 3 months after completion of the Program. Waitlist control group will also have these measures at baseline, end of the 10 week waiting list period, after completing the 10week ESTEEM Program, and at 3 month follow-up following completion of the Program.

Eligibility
Key inclusion criteria
(i) stroke survivors who meet the following inclusion criteria:
• Agreeing (and intending) to participate in the 10-week ESTEEM Program;
• Community dwelling adults aged 18 years or older who have experienced a stroke event, not living in a residential care facility;
• Have the cognitive and communicative capacity to provide informed consent and follow instructions as determined by the referring health professional;
• Ability to stand independently or with the assistance of one person;
• Ability to use the washroom independently or with a support person who is able to attend the ESTEEM Program; and
• Medically fit (i.e., without absolute contraindications to exercise and able to attend and participate in group exercise (i.e., no co-morbidities preventing regular exercise).

(ii) carers of stroke survivors participating in the ESTEEM Program research, who assist with activities of the survivors daily living will be asked to participate in the research. A carer is defined according to The Carers (Recognition) Act 2010, No 20. Under this Act, a person is a carer if the person is an individual who provides ongoing personal care, support and assistance to any other individual who needs it because that other individual:
(a) Is a person with disability within the meaning of the Disability Inclusion Act 2014, or
(b) Has a medical condition (including a terminal or chronic illness), or
(c) Has a mental illness, or
(d) is frail and aged.
Under this act, a person is not a carer if the care, support and assistance that the person provides is:
(a) Under a contract of service or a contract for the provision of services, or
(b) In the course of doing voluntary work for a charitable, welfare or community organisation, or
(c) As part of the requirements of a course of education or training.

To avoid doubt, a person is not a carer of another person for the purposes of this Act merely because the person:
(a) Is the spouse or de facto partner of the person, or
(b) Is the parent, guardian, child or other relative of the other person, or
(c) Lives with the other person.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion for stroke survivors:
* Have not previously participated in any previous phase of the ESTEEM After Stroke Research Program

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)
Those who deem an individual eligible to participate will not be aware of allocation at the time of screening and consenting.
Allocation of participants into Intervention or Waitlist-Control groups, is based on a stratified randomisation process performed after the Baseline assessment has been conducted. Randomisation is based on information and data collected at this assessment - time after stroke, and physical function.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be applied within each stratum, with the randomisation schedule generated by an independent statistician at HMRI and uploaded to the REDCap database for implementation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This trial is operating on a waitlist-control design.
Participants randomised into the Intervention group will begin the ESTEEM Program as soon as a position is available (optimally within 2 weeks). Those who are randomly allocated to the Waitlist-Control group will be offered the opportunity to participate in the ESTEEM Program after the minimum 10 week waitlist waiting period.
Therefore both groups will have the opportunity to participate in the Program.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the physical health primary outcome, a minimally clinically important difference of 1.0 point has been established in a general population. Exercise-based trials in similar stroke populations have reported a standard deviation of approximately 2.4points. To detect this MCID with 90% power and a 5% Type-I error rate, a sample size of 122 participants per group at program end (10 weeks) would be required.
For the co-primary quality of life health outcome, a MCID of 0.06 points has been determined with a high intra-person correlation over time of 0.89. Personal correspondence with the developer of this instrument suggests that a difference of this size would map to this outcome, corresponding to a standardized effect size of 0.1667 (Cohen's d). A sample size of 122 participants per group will be needed to detect this MCID with 80% power and a 5% Type-I error rate. Accounting for 10% dropout rate, 135 participants per group will be required.

The primary analysis will be conducted on an intention-to-treat basis. Differences between groups in the primary outcome variables will be assessed using linear regression models, with a separate model for each outcome.
Data collected from the waitlist control group participants that go onto participate in the ESTEEM Program (waitlist intervention group) will be used in a sensitivity analysis where a preservation of the effect size with a reduction in the variation of the effect size (i.e., narrowing of the confidence interval), will be considered positive/confirmation. A liner missed model will be used for this analysis, with a fixed effect for the baseline value of the outcome, treatment (intervention vs control), the pre-specified independent variables from the primary analysis, and a random subject level intercept to account for repeated from the waitlist controls who partake in the intervention.
Where deviations from the randomised group allocations occur (e.g., a participant randomised to intervention is unable to start the program on the specified time, and then moves to control group), the baseline data of these participants will be compared to the baseline data of those who proceed per protocol.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/04/2025
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
25/10/2027
Actual
Sample size
Target
270
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306703 0
Other
Name [1] 306703 0
Hunter Medical Research Institute/Women in Medical Research Fellowship
Country [1] 306703 0
Australia
Funding source category [2] 313277 0
Government body
Name [2] 313277 0
National Health & Medical Research Council/MRFF
Country [2] 313277 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University DriveCallaghan NSW 2308Australia
Country
Australia
Secondary sponsor category [1] 307251 0
Government body
Name [1] 307251 0
NSW Health - Hunter New England Local Health District
Address [1] 307251 0
N/A
Country [1] 307251 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306873 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 306873 0
Ethics committee country [1] 306873 0
Australia
Date submitted for ethics approval [1] 306873 0
22/01/2025
Approval date [1] 306873 0
03/02/2025
Ethics approval number [1] 306873 0
2020/ETH01723

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

Contacts
Principal investigator
Name 105302 0
Dr Heidi Janssen
Address 105302 0
Hunter Medical Research InstituteStroke Research Team Level 3 EastLot 1, Kookaburra Circuit, New Lambton Heights NSW 2305Mailing Address: HMRI, Locked Bag 1000, New Lambton NSW 2305
Country 105302 0
Australia
Phone 105302 0
+61 4473 434 389
Fax 105302 0
Email 105302 0
[email protected]
Contact person for public queries
Name 105303 0
Heidi Janssen
Address 105303 0
Hunter Medical Research InstituteStroke Research Team Level 3 EastLot 1, Kookaburra Circuit, New Lambton Heights NSW 2305Mailing Address: HMRI, Locked Bag 1000, New Lambton NSW 2305
Country 105303 0
Australia
Phone 105303 0
+61 4473 434 389
Fax 105303 0
Email 105303 0
[email protected]
Contact person for scientific queries
Name 105304 0
Heidi Janssen
Address 105304 0
Hunter Medical Research InstituteStroke Research Team Level 3 EastLot 1, Kookaburra Circuit, New Lambton Heights NSW 2305Mailing Address: HMRI, Locked Bag 1000, New Lambton NSW 2305
Country 105304 0
Australia
Phone 105304 0
+61 4473 434 389
Fax 105304 0
Email 105304 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?



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.