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Trial registered on ANZCTR


Registration number
ACTRN12620000544976
Ethics application status
Approved
Date submitted
25/03/2020
Date registered
6/05/2020
Date last updated
7/04/2024
Date data sharing statement initially provided
6/05/2020
Date results information initially provided
16/01/2023
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 pilot study of a personalised and multi-dimensional compression assessment and intervention (PAMCAI) tool
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 clinical decision-aid comprising a new questionnaire, to identify patient-specific barriers to compression adherence, followed by the systematic implementation of behavioural strategies via a clinical decision-making algorithm, attempting to improve patient adherence to wearing compression stockings. This clinical decision-aid is called the Personalised and Multidimensional Compression Assessment and Intervention (PAMCAI) tool. Participants in the intervention will receive the PAMCAI tool in addition to standard care. For the purpose of this trial, the PAMCAI too will be implemented via an electronic App, delivered via an iPad.

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.

The PAMCAI tool will be incorporated into existing occupational therapy outpatient clinics dedicated to the treatment of vascular conditions, to be delivered by Occupational Therapists..

Participants in the intervention group will be assessed at their initial appointment using a new Barriers to Adherence Questionnaire. This comprises 24 questions to be answered Yes or No. The clinician completes the questionnaire with the patient. If a Yes response is recorded, the significance of an issue will be rated from 1 (mild) to 5 (severe). The electronic App will select the top three responses.
A clinical decision-making algorithm will provide suggestions and resources 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, the intervention uses tools and frameworks guided by behaviour change theory supportive of individual barriers to adherence. This algorithm has been developed in accordance with Michie's Behaviour Change taxonomy in consultation with a selective sample of experts to inform our recommendations.

The 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 (initial and final). Intervention participants may receive three of four appointments during this period. The minimum number of appointments will be 2.

Both control and intervention participants will be recruited by the primary investigator (PI). After obtaining consent, participants will be randomised to either a control or intervention group. Both groups will be contacted by the PI who will obtain initial Demographic and economic details and conduct the CIVIQ-14 and EuroQuol EQ-5D-5L quality of life assessments. During the initial clinical appointment, the intervention group will be assessed by the treating OT with the VCSS, Adhesig Screening tool and their frequency of their stocking wear will be clarified. The PAMCAI tool will be implemented which includes the Compression Adherence Questionnaire which will list the patient specific barriers. At the final assessment, the VCSS, Adhesig, Frequency of Wear and 2 quality of life assessments will be repeated, and demographic and medical information will be reviewed.

As adherence is the primary outcome measure for this study, this 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. The 10th question of the VCSS considers Compression Wear. This is rated as 0 (not used) to 3 (full compliance).
To ensure inter-rater reliability, we have defined the terms as percentages.
0 = not used: stockings are worn 1-10% of the time that is recommended.
1 = intermittent use: stockings are worn 11-50% of the time that is recommended
2 = most days: stockings are worn 51% to 90% of the time that is recommended.
3 = full compliance: stockings are worn greater than 90% of the time that is recommended.

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 timeframe 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, expectations for their garment wear will be documented, 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.


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 or 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.

The questions posed within the questionnaire follow:
Stocking Comfort:
1. Are stockings digging in at the ankle?
2. Do stockings feel too tight generally?
3. Do stockings slide down the leg?
4. Are stockings digging in at the top of the leg?
5. Are stockings too tight at the base of the toes?
6. Are stockings too tight over the toes themselves?
7. Is the fabric irritating the skin?
8. Is the foot section sliding up the foot (open toe stocking)?
9. Is there a large foot compared to a thin leg?
10. Do stockings feel too hot to wear sometimes?
11. Is there irritation from a silicone grip top/band?
Patient understanding:
12. Is there a limited understanding of their medical condition?
13. Is there a limited understanding of why stockings are needed?
14. Was there a previous negative experience with stockings?
15. Was there previous conflicting medical advice?
16. Could the patient be experiencing low mood?
17. Does the patient have low belief in their own abilities
Concern about Appearance:
18. Is the patient concerned that stockings will make them look old/frail?
Applying and removing Stockings:
19. Is the patient unable to put stockings on?
20. Does the patient have wounds or dressings?
21. Is the patient unable to get stockings off?
Caring for stockings:
22. Does the patient not know how to take care of their stockings (knowledge)?
23. Does that patient have difficulty taking care of their stockings (memory/planning)?
24. Does the patient not know who to contact if they have any problems/stockings need replacing?

Each question has its own separate answer (suggestion) sheet in response.
Some questions will prompt the clinician to consider booking the patient in for another visit or a phone call.
Some questions will prompt the use of various patient handouts or videos.
Intervention code [1] 317181 0
Treatment: Other
Comparator / control treatment
Standard care:
For those participants in the control group, some data collection will occur after the initial OT appointment so as not to influence or bias the treating OT’s intervention. This will be carried out by an OT assistant either face to face or over the phone. The OT assistant will complete the Adhesig and Frequency of wear assessment and the questionnaire portion of the PAMCAI tool “the Barriers to Compression Questionnaire”. This information will not be made available to the treating OT until after the study is complete.
The OT will conduct the VCSS (max 3 minutes to complete) within the standard appointment. The OT will complete this at the initial and final appointment within the 6-month timeframe 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 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
Secondary outcome [2] 406193 0
CIVIQ-14: A quality of life instrument for patients with chronic venous disease
Timepoint [2] 406193 0
Approximately 1 week prior to the initial face-to-face clinical assessment. Again, 6 months later, approximately 1 week following the last clinical assessment.
Secondary outcome [3] 406194 0
EuroQol EQ-5D-5L: A quality of life measure, on 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [3] 406194 0

Approximately 1 week prior to the initial face-to-face clinical assessment. Again, 6 months later, approximately 1 week following the last clinical assessment.
Secondary outcome [4] 406195 0
Adhesig Screen: Screening tool for adherence to compression garments, which provides an 'Adherence' versus 'Poor Adherence' determination based on the patient responses to 5 questions.
Timepoint [4] 406195 0
Prior to recruitment, (part of checking for eligibility for study). Again at the initial face-to-face clinical assessment. Again, 6 months later, at the last clinical assessment.
Secondary outcome [5] 406196 0
Economic Data from the perspective of the hospital, calculating the difference between resource use and costs, from hospital medical records, and economic benefits such as quality life adjusted life years (QALYS)
Timepoint [5] 406196 0
QALYS will be calculated using data obtained from the EuroQol (collected at the initial phase of the clinical intervention described above) and economic data (collected throughout the timeframe of the study intervention).
Secondary outcome [6] 406197 0
Occupational Therapy documentation references: to collect and compare Occupational Therapy documentation following initial assessment, final assessment, and any assessments in the interim period regarding any documented references to adherence, and/or any attempts to influence adherence and/or any discussion or identification of barriers to adherence.
Timepoint [6] 406197 0
The pilot study only. The documentation will be collected following the last assessment within the 6-month timeframe.
It will include documentation gathered within all points in time from the initial assessment to the last assessment.
A data collection form will structure data collection under headings of;
Reference to adherence (yes/no), dates and details.
Reference to barriers (yes/no), dates and details.
Reference to attempts to address a barrier (yes/no), dates and details.

Eligibility
Key inclusion criteria
Inclusion criteria:
- Ages 18+
- Current medical referral for compression stockings for management of venous leg ulcers
- CEAP level C5 (ie. healed VLU)63
- Reside within GCHHS boundaries
- Hold a current Pension or Health Care Card
- Intact cognition: patient can understand and answer questions about the study in relation to the consenting process
- Ability to understand English
- Identified low adherence to compression therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to give informed consent
- Inability to understand English
- CEAP other than C5
- 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
Please note that this research comprises a Pilot RCT and health economics study
PARTICIPANT SAMPLE SIZE:
For the pilot study, a sample size of 10 participants in each group was determined to be sufficient to meet the pilot aims and minimize waste of clinical resources and patient or clinician inconvenience.

A meaningful difference in stocking adherence, determined as 1 point on the VCSS Compression Therapy four-point interval sub-score.

DATA ANALYSIS:

Pilot RCT and cost-utility analysis: In consideration of the Pilot Study Aims of checking feasibility and proof of concept prior to conducting the full study, a clinician feedback mechanism will be conducted, documentation references will be reviewed, and research project data will be collected. The intent will be to determine if (and by how much) PAMCAI changes practice.

Feasibility of data collection and statistical analysis methods will be undertaken for the pilot study under the domains of:

Adherence: To evaluate possible associations between patient characteristics and the adherence score, t-tests will compare the two groups. A multi-linear regression will be used to compare variables to the end point of adherence. Additionally, a regression analysis will be used to take into consideration, covariates including severity of VLU, age and relevant comorbidities. If the study suggests that the data collected does not adhere to a normal distribution, we will apply a Mann Whitney U test or a logistical regression which will require several assumptions to be made, i.e., rather than assuming equal differences between each score, clinical experience will determine an ‘odds ratio’ of a participant improving one point on the VCSS compression score. SPSS software will be employed to analyse RCT data.

Cost-utility analysis: A within trial cost-utility analysis will be undertaken from the perspective of the health funder with a six-month time horizon. GCH related service types and frequencies will be costed. Health utility indices will be calculated via the EQ-5D-5L and mapped over time with the area under the curve used to calculate the quality adjusted life years (QALY). An incremental cost-effectiveness ratio will be estimated where: Cost Utility = (cost PAMCAI – cost usual care) / (QALY PAMCAI – QALY usual care).




Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/03/2022
Actual
13/04/2022
Date of last participant enrolment
Anticipated
2/08/2022
Actual
1/10/2022
Date of last data collection
Anticipated
12/06/2023
Actual
12/06/2023
Sample size
Target
20
Accrual to date
Final
20
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
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
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
11/09/2020
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 to wearing these stockings is low. Ulcers are very costly to patients and health care systems.
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 investigate whether a new clinical decision-aid can improve adherence with wearing compression stockings by using a new questionnaire to inform on each patient’s specific barriers and a decision tree (or algorithm) which will then instruct the clinician how to address each of those barriers. The intent is to guide both novice and experienced clinicians to the next level of care delivery. This questionnaire and algorithm are combined into the Personalised and Multidimensional Compression Assessment and Intervention (PAMCAI) tool. The study will take place within the Gold Coast Hospital and Health Service across two Occupational Therapy Vascular outpatient clinics. The study will also investigate if there are any economic benefits from using this tool.
A pilot study will investigate if the study design is feasible and shows potential to improve adherence. Completion of this phase will allow for any changes to the tool or the research design before the next phase commences (a randomised controlled trial which includes a health economics study and a series of qualitative interviews is planned to explore participant’s experiences and perceptions of the intervention and how they influenced adherence, if they did).
The predicted benefits of conducting this pilot study include opportunity to trial the PAMCAI tool in practice, gaining feedback on usability and potential benefit in influencing adherence to wearing compression stockings. Further, it will provide information on feasibility of recruitment, data gathering, clinician acceptability while allowing for alternations as required prior to conducting a full research design.

The predicted benefits of the overall research design, include health care savings, improved patient outcomes, with the potential to use this tool in multiple settings and by different health disciplines.
Trial website
Trial related presentations / publications
Public notes
A final amendment to the original Ethics and SSA was approved 12.4.23

Contacts
Principal investigator
Name 101078 0
Miss Laila Bar
Address 101078 0
Occupational Therapy, Faculty of Health Science and Medicine, Bond University, Queensland, Australia
Country 101078 0
Australia
Phone 101078 0
+61 0413855090
Fax 101078 0
Email 101078 0
[email protected]
Contact person for public queries
Name 101079 0
Laila Bar
Address 101079 0
Occupational Therapy, Faculty of Health Science and Medicine, Bond University, Queensland, Australia
Country 101079 0
Australia
Phone 101079 0
+61 07 55955530
Fax 101079 0
Email 101079 0
[email protected]
Contact person for scientific queries
Name 101080 0
Laila Bar
Address 101080 0
Occupational Therapy, Faculty of Health Science and Medicine, Bond University, Queensland, Australia
Country 101080 0
Australia
Phone 101080 0
+61 0413855090
Fax 101080 0
Email 101080 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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.