Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000565448
Ethics application status
Approved
Date submitted
17/04/2025
Date registered
2/06/2025
Date last updated
2/06/2025
Date data sharing statement initially provided
2/06/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study of WoundView telehealth program for chronic wounds in residential aged care
Scientific title
WoundView pilot and feasibility study: Evaluation of a novel virtual care intervention for managing chronic wounds in residential aged care settings
Secondary ID [1] 313912 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic wounds 336620 0
Condition category
Condition code
Skin 333122 333122 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, the WoundView plugin, is a novel wound analysis tool integrated with an existing video telehealth platform (Coviu). WoundView links residents who have chronic wounds, and their clinical care staff in Residential Aged Care Homes (RACHs) to external healthcare providers such as wound care specialists, wound nurses, and GPs.

External healthcare providers will deliver expert wound care to residents with chronic wounds using the WoundView plugin. The WoundView plugin is a software component that extends the functionality of the existing Coviu telehealth platform. All consultations will take place via telehealth with the resident and their clinical care team in the RACH. WoundView will be used for chronic wound management as often as is required based on the clinical needs of each participant. The participating RACHs are in rural and urban New South Wales, Australia.

During the study, resident participants with chronic wounds will be referred to an external healthcare provider who will deliver virtual wound care using the WoundView plugin. Consumer-grade devices such as laptops, mobile phones and tablets will be used by the RACH and external healthcare provider to access WoundView. WoundView will be used in the initial wound assessment lasting approximately 30-45 minutes. During the assessment, wound images will be captured, and all call data (images and documents) will be transmitted peer-to-peer (i.e., between consultation participants) and protected with end-to-end encryption. Ongoing wound consultations and assessments will be undertaken using the WoundView plugin for the duration of the study (approximately three months). WoundView will be used to capture wound images at each wound dressing change (range 3-14 days). A report on WoundView usage will be run weekly by the research team for the duration of the study.
Intervention code [1] 330517 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341138 0
Participant recruitment
Timepoint [1] 341138 0
Upon conclusion of the study
Primary outcome [2] 341278 0
Participant retention
Timepoint [2] 341278 0
Upon conclusion of the study
Primary outcome [3] 341279 0
Protocol adherence
Timepoint [3] 341279 0
Upon conclusion of the study
Secondary outcome [1] 446470 0
Stakeholder acceptability - This is an additional primary outcome
Timepoint [1] 446470 0
Upon completion of the 3-month intervention
Secondary outcome [2] 446471 0
Wound measurements (wound bed length, width and calculated area) from each telehealth consultation/assessment (will be assessed as a composite outcome).
Timepoint [2] 446471 0
Baseline, at any wound assessment throughout the intervention period and upon completion of the 3-month intervention
Secondary outcome [3] 446472 0
Telehealth consultation length and participants (will be assessed as a composite outcome)
Timepoint [3] 446472 0
Baseline, at any wound assessment throughout the intervention period and upon completion of the 3-month intervention
Secondary outcome [4] 446473 0
Health-related quality of life
Timepoint [4] 446473 0
Baseline and upon completion of the 3-month intervention
Secondary outcome [5] 446474 0
Self-rating of skills and confidence before and after WoundView training (will be assessed as a composite outcome)
Timepoint [5] 446474 0
Before and after training
Secondary outcome [6] 446475 0
Patient experience and satisfaction (will be assessed as a composite outcome)
Timepoint [6] 446475 0
Upon completion of the 3-month intervention
Secondary outcome [7] 446476 0
Staff experience and satisfaction (will be assessed as a composite outcome)
Timepoint [7] 446476 0
Upon completion of the 3-month intervention
Secondary outcome [8] 446477 0
Hospitalisations for wound-related care during the study period
Timepoint [8] 446477 0
Upon completion of the 3-month intervention
Secondary outcome [9] 446478 0
Health resource utilisation case studies
Timepoint [9] 446478 0
Assessed at any wound assessment throughout the intervention period
Secondary outcome [10] 447002 0
Health-related quality of life
Timepoint [10] 447002 0
Baseline and upon completion of the 3-month intervention
Secondary outcome [11] 447003 0
Emergency Department presentations for wound-related care during the study period
Timepoint [11] 447003 0
Baseline and upon completion of the 3-month intervention
Secondary outcome [12] 448084 0
Time to 35% reduction in wound area, time to complete healing, percentage area reduction (PAR) and gross area reduction (GAR) (will be assessed as a composite outcome).
Timepoint [12] 448084 0
Baseline, at any wound assessment throughout the intervention period and upon completion of the 3-month intervention

Eligibility
Key inclusion criteria
Residents:
- Willing and able to give informed consent for participation in the study
- Have a chronic wound at the start of the study period or develop a chronic wound during the study period
- A chronic wound is defined as a wound that has been present for three or more weeks OR is likely to take three or more weeks to heal. The wound must be considered suitable for active treatment as per advice of RACH staff.

RACH staff and external healthcare providers:
All staff employed by the participating RACHs and external healthcare providers such as wound care specialist, wound care nurses and General Practitioners, will be eligible to participate in the study if they are aged 18 years or over and can undertake data collection in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents:
- Cognitive impairment that affects ability to provide informed consent as determined by the facility managers, RACH staff and/or research teams’ clinical judgement at the point of enrolment.
- Sensory or physical that would preclude data collection participation, as determined by the facility managers, RACH staff and/or research teams’ clinical judgement at the point of enrolment
- Other health impairment that would preclude data collection participation including residents who are reliant on medications in the following circumstances:
a. Participants receiving medication to support end-of-life care (e.g., morphine syringe driver)
b. Participants with severe mental health conditions where their condition is not adequately controlled by medication at the time of recruitment.
- Have superficial, rapidly healing wounds such as abrasions, blisters, or lacerations
- Chronic wound located on the genital area
- Not fluent in spoken or written English

RACH staff and external healthcare providers:
- Not fluent in spoken or written English

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The number of participants needed to achieve the study objectives was not calculated as this is a pilot and feasibility study being undertaken in preparation for further research. The study objectives will be achieved by enrolling up to 15 residents, ten RACH staff and ten external healthcare providers or as is required to achieve data saturation.

Descriptive statistics will be used to summarise survey results. Comparative statistics will compare findings at baseline, throughout and at the pilot end point. Thematic inductive analysis will be undertaken using NVIVO software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/05/2025
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
35
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318385 0
Government body
Name [1] 318385 0
Medical Research Future Fund (MRFF) Rapid Applied Research Translation grant (RARUR000158), Department of Health 2022: Transforming Wound Care through Telehealth in Aged Care.
Country [1] 318385 0
Australia
Primary sponsor type
University
Name
School of Rural Health, The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320785 0
None
Name [1] 320785 0
Address [1] 320785 0
Country [1] 320785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317018 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 317018 0
Ethics committee country [1] 317018 0
Australia
Date submitted for ethics approval [1] 317018 0
02/09/2024
Approval date [1] 317018 0
06/11/2024
Ethics approval number [1] 317018 0

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

Contacts
Principal investigator
Name 139750 0
A/Prof Georgina Luscombe
Address 139750 0
School of Rural Health, The University of Sydney, Australia Cnr Acacia Way and Canobolas Drive Bloomfield Campus 1502 Forest Road Orange NSW 2800
Country 139750 0
Australia
Phone 139750 0
+61 02 53104127
Fax 139750 0
Email 139750 0
[email protected]
Contact person for public queries
Name 139751 0
Dr Heather Russell
Address 139751 0
School of Rural Health, The University of Sydney, Australia Cnr Acacia Way and Canobolas Drive Bloomfield Campus 1502 Forest Road Orange NSW 2800
Country 139751 0
Australia
Phone 139751 0
+61 02 53104134
Fax 139751 0
Email 139751 0
[email protected]
Contact person for scientific queries
Name 139752 0
Dr Heather Russell
Address 139752 0
School of Rural Health, The University of Sydney, Australia Cnr Acacia Way and Canobolas Drive Bloomfield Campus 1502 Forest Road Orange NSW 2800
Country 139752 0
Australia
Phone 139752 0
+61 02 53104134
Fax 139752 0
Email 139752 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Data will be collected from a small sample of older adults and appropriate consent for future use of the data has not been sought.



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24635Ethical approval    Decision notification letter_application_06112024.pdf



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.