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Trial registered on ANZCTR


Registration number
ACTRN12620000544976p
Ethics application status
Submitted, not yet approved
Date submitted
25/03/2020
Date registered
6/05/2020
Date last updated
6/05/2020
Date data sharing statement initially provided
6/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Adherence with compression stockings in the management of venous leg ulcers
Scientific title
Patient adherence to wearing compression stockings in the management of venous leg ulcers: a randomised controlled trial and qualitative study of an occupational therapy package
Secondary ID [1] 300856 0
nil
Universal Trial Number (UTN)
1111-1250-1299
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous leg ulcers 316762 0
Condition category
Condition code
Skin 314992 314992 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention tests a new model of care deemed an enhanced model of care as opposed to standard care, involving the identification of patient-specific barriers followed by the systematic implementation of behavioural strategies to attempt to improve the adherence to wearing compression stockings. This new model of care is labelled an 'Occupational Therapy (OT) Package of Care'. Participants will receive the benefit of systematic identification of barriers and implementation of a treatment strategy in addition to standard care.

Each intervention group participant, in addition to standard care, will have a longer initial assessment hence more time to gather patient information and gain rapport. Participants will be assessed by the Barriers to Compression Questionnaire to determine their particular barriers to compression. The treating therapist, will implement an algorithm either via a paper-based or an electronic version depending on the preferences of the therapist, to provide a list of recommendations for each barrier identified.


Examples of barriers that may be identified and how they may be addressed:
1. Stockings are not comfortable: a) Change to a different style of stocking eg. from a circular-knit stocking to a flat-knit, or cut and sew fabric b) improved sizing eg larger foot or custom sizing c) change to a different fabric which causes less skin reaction
2. Unable to get stockings on and off: a) trial of different applicators that can assist the patient to manage on their own b) teaching a carer how to assist c) getting community assistance from an NGO to come into the home in the morning and/or at night
3. Poor patient understanding of their condition and/or why they need to wear stockings: a) individualized education provided based on their level of understanding b) including carers/family in receiving education
4. Poor motivation to wear stockings: a) additional face to face encounters to provide encouragement and positive reinforcement and answer any queries b) OT or OT assistant support phone calls between visits to motivate and remind patients to continue with their stockings.

This OT Package of Care will be incorporated into existing OT outpatient clinics dedicated to the treatment of vascular conditions.

Occupational Therapists, with clinical experience in providing a service within an Occupational Therapy Vascular and Lymphoedema Outpatient clinic will deliver this service model.

Participants in the intervention group will be assessed at their initial appointment using a Barriers to Adherence Questionnaire. An algorithm will then be implemented to address the barriers identified. This algorithm has been developed specifically for this study based on clinical experience, expert opinion and consumer feedback. As adherence to compression stockings requires a change in individual behaviour, interventions should use tools and frameworks guided by behaviour change theory supportive of individual barriers to adherence. Therefore, the algorithm has been developed in accordance with Michie's Behaviour Change taxonomy in consultation with a selective sample of experts to inform our recommendations. This algorithm will be presented either in booklet form or via a prototype electronic app (downloadable to mobile device/or iPad). The algorithm will result in a list of recommendations for the clinician to follow.

Frequency of visits during the 6 month intervention period will be dependent on the recommendations from the algorithm. It is likely that each participant in the control group will be seen on two occasions. Intervention participants are likely to be seen three of four times in total during this time period. Minimum visits will be 2. Maximum visits will be 4, during each participant's 6 month intervention period.

During the initial OT visit, the participant will receive introductory information. The OT will then assess the participant with the VCSS, the ADHESIG screening tool and collect information on frequency of wear (days per week and time per day). They will be assessed via the Compression Adherence Questionnaire which will list the patient specific barriers. The algorithm will be used (either via an App or a paper-based version) which will inform the clinician how to address each barrier. During this appointment, and any subsequent appointments, the aim will be to continue to address these barriers. At the final review, the participant will again be assessed using the VCSS, and the ADHESIG screening tool + frequency of wear.

As adherence is the primary outcome measure for this study, this will be will be a focus of all interventions, based on patient report and clinician observation - using the Adhesig Screening tool and frequency of wear questionnaire to collect data about this.

Adherence, for the purposes of this study will be considered to be: wearing compression stockings as recommended by the health practitioner. Please note that a time-frame is not included here as there are variations in health practitioner expectations. Almost always, the expectation is to wear the stocking all day every day, but not in every single case. For each participant, we will make note of the expectations for their garment wear, and their level of adherence will be determined as a percentage of that total time.

In summary, our intervention will attempt to improve adherence in those with identified low adherence with the wearing of compression stockings by identifying personal barriers and then addressing each of them in a systematic way.
Intervention code [1] 317181 0
Treatment: Other
Comparator / control treatment

Standard care:
For those participants in the control group, an OT assistant will meet them prior to their appointment to assist them to complete the Adhesig and Frequency of wear assessment. This information will not be made available to the treating OT so as not to contaminate their intervention.
Once the appointment commences, the OT will conduct the VCSS (max 3 minutes to complete). The OT will complete this at the initial and final appointment within the 6 month time-frame of their involvement in the study.

Each control group participant receives a standard initial assessment designed to determine the necessary leg history, personal situation, history with stockings. The Occupational Therapist measures and fits stockings as required. The therapist uses their clinical reasoning within a time-limited period (usually 30 minutes) to select the appropriate stockings and provide education and handouts as required. Participants are informed that they can call to request an appointment earlier than at 6 months if they feel they require it. If no contact is made by the participant during that time, the participant will not be reviewed again until their regular 6-month appointment.



Control group
Active

Outcomes
Primary outcome [1] 323296 0

The number of participants with a clinically meaningful difference in adherence to wearing compression stockings will be based on a change of 1 point of the 'Compression Wear' sub-score of the Venous Clinical Severity Score. This was calculated with a standard deviation from 1.14 power of 0.8 and alpha 0.5.
Timepoint [1] 323296 0
Initial assessment and 6 months later at final assessment
Secondary outcome [1] 381474 0
Change in severity of identified barriers (scored 1-5) to compression based on the newly developed Barriers to Compression Questionnaire.
Timepoint [1] 381474 0
Initial assessment and 6 months later at final assessment

Eligibility
Key inclusion criteria
Inclusion criteria:
- Ages 18+
- Current medical referral for management of venous leg ulcers
- Reside within Gold Coast Health and Hospital Service boundaries
- Hold a current Pension or Health Care Card
- Intact cognition and ability to understand English
- Identified low adherence to compression therapy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Exclusion criteria:
- Inability to give informed consent
- Inability to understand English
- Contraindications for wearing compression for the management of VLUs
- Resident in a high care facility
- Identified acceptable adherence to compression therapy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
QLD
Recruitment hospital [1] 16156 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 29695 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305308 0
Hospital
Name [1] 305308 0
Gold Coast Hospital and Health Service
Address [1] 305308 0
1 Hospital Boulevard
Southport
QLD 4215
Country [1] 305308 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
Occupational Therapy Department
Allied Health Outpatients
Level 1
Gold Coast University Hospital
1 Hospital Boulevard
Soutport, QLD 4215
Country
Australia
Secondary sponsor category [1] 305673 0
University
Name [1] 305673 0
Bond University
Address [1] 305673 0
Bond Institute of Health and Sport
2 Promethean Way
Robina QLD 4226
Country [1] 305673 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305647 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305647 0
Gold Coast University Hospital
Level 2, E Block (PED building)
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 305647 0
Australia
Date submitted for ethics approval [1] 305647 0
06/04/2020
Approval date [1] 305647 0
Ethics approval number [1] 305647 0

Summary
Brief summary
Wearing compression stockings is the best treatment to heal venous leg ulcers and prevent new ones, but adherence with wearing these stockings is low. Multiple known reasons (barriers) exist to explain why patients don’t wear their stockings and most patients have several barriers at once. The study aims to test whether an Occupational Therapy package of care can improve adherence with wearing compression stockings by using a new assessment tool to inform us what each patient’s specific barriers are, and a decision tree (or algorithm) which will then instruct the clinician how to address each of those barriers. Our full study will comprise of two parts: A randomised controlled trial followed by a series of qualitative interviews to discover participant’s experiences and perceptions of the package and how they influenced adherence, if they did.
The predicted benefits of this research include health care savings, improved patient outcomes, with potential to use this algorithm in multiple settings including community, rural and acute care settings in Australia and worldwide.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101078 0
Miss Laila Bar
Address 101078 0
Occupational Therapy Vascular and Lymphoedema Outpatient Clinic
Allied Health Outpatient Department
Level 1
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 101078 0
Australia
Phone 101078 0
+61 7 56356445
Fax 101078 0
Email 101078 0
Laila.Bar@student.bond.edu.au
Contact person for public queries
Name 101079 0
Miss Laila Bar
Address 101079 0
Occupational Therapy Vascular and Lymphoedema Outpatient Clinic
Allied Health Outpatient Department
Level 1
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 101079 0
Australia
Phone 101079 0
+61 1300744284
Fax 101079 0
Email 101079 0
Laila.Bar@student.bond.edu.au
Contact person for scientific queries
Name 101080 0
Miss Laila Bar
Address 101080 0
Occupational Therapy Vascular and Lymphoedema Outpatient Clinic
Allied Health Outpatient Department
Level 1
Gold Coast University Hospital
1 Hospital Boulevard
Southport QLD 4215
Country 101080 0
Australia
Phone 101080 0
+61 1300744284
Fax 101080 0
Email 101080 0
Laila.Bar@student.bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this time, prior to ethics approval, we are not able to confirm what we will be able to share.
What supporting documents are/will be available?
No other documents available
Summary results
No Results