Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001504202
Ethics application status
Approved
Date submitted
16/07/2018
Date registered
6/09/2018
Date last updated
6/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of patient knowledge, treatment utilisation and severity of hidradenitis suppurativa following dermatology nurse education program: A randomised cross-over study
Scientific title
Comparison of patient knowledge, treatment utilisation and severity of hidradenitis suppurativa following dermatology nurse education program: A randomised cross-over study
Secondary ID [1] 294611 0
None
Universal Trial Number (UTN)
U1111-1217-5205
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hidradenitis suppurativa 308857 0
Condition category
Condition code
Skin 307779 307779 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention employed in this project is a nurse-led education session provided by a highly experienced dermatology clinical nurse, to take place in the dermatology outpatient department at Princess Alexandra Hospital.
The sessions will be individualised to each participant but, in general, will provide education about the nature of the condition, how/when/where to apply topical medications and dressings (with demonstration), modification of lifestyle factors known to contribute to hidradenitis suppurativa severity (eg weight loss and smoking cessation) and pain management.
Each session will take an estimated 45-60 minutes and will be followed up by a phone call several weeks later to address any questions or concerns that have arisen.

The sessions will not be recorded

Although the individual topics covered in the nurse-led education session is often discussed in the dermatology clinic during a standard consultation as part of standard care. An individualised hour-long session specifically devoted to education is not provided as standard.
By providing this additional education as an adjunct to standard therapy, we hope to demonstrate improvement in patient outcomes relating to the measures described earlier.
Intervention code [1] 301871 0
Treatment: Other
Comparator / control treatment
Participants will be allocated randomly using a randomisation sequence generated by Microsoft Excel using random block sizes of two (2). Randomisation and allocation of participants will be performed by the dermatology nurse who will be administering the education sessions.
Allocations will be concealed from the researchers who will be analysing the collected data.
Participants allocated to the intervention group will be provided with the education session whilst participants allocated to the control session will not receive any additional education. At the 8-week mark of the project, the groups will switch so that the participants initially allocated to the control group will then be provided with the education session. Nil further education sessions will be provided to the (original) intervention group.
Control group
Active

Outcomes
Primary outcome [1] 306767 0
Change in self-management and empowerment as measured by the HEIQ score
Timepoint [1] 306767 0
1. 8 weeks post-randomisation
2. 16 weeks post-randomisation
Primary outcome [2] 306768 0
Change in quality of life as assessed by the DLQI score
Timepoint [2] 306768 0
1. 8 weeks post-randomisation
2. 16 weeks post-randomisation
Secondary outcome [1] 349537 0
Quantity of medications used as recorded in patient diaries
Timepoint [1] 349537 0
1. 8 weeks post-randomisation
2. 16 weeks post-randomisation

Eligibility
Key inclusion criteria
• Patients with severe hidradenitis suppurativa (HS) who attend the Princess Alexandra Hospital HS Multidisciplinary clinic.
• Primary language is English
• Aged 18 years or older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Primary language other than English
• Unable/unwilling to provide consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed to the intervention provider.
Allocation is concealed to other investigators with the aid of central randomisation via computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated randomly using a randomisation sequence generated by Microsoft Excel using random block sizes of two (2).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The design is similar to a cross-over study in that the arms switch at the halfway point of the trial. However, as the initial intervention group have already received the education and cannot 'unlearn' this, they cannot truly be their own control. The study aims to determine whether the group who receive the education only in the second half of the trial 'catches up' to the group who initially received the intervention.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2018
Actual
Date of last participant enrolment
Anticipated
25/09/2018
Actual
Date of last data collection
Anticipated
15/01/2019
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11445 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 23460 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 299227 0
Self funded/Unfunded
Name [1] 299227 0
Dr Bradley Miller
Country [1] 299227 0
Australia
Funding source category [2] 300417 0
Hospital
Name [2] 300417 0
Dermatology Dept
Country [2] 300417 0
Australia
Funding source category [3] 300586 0
Self funded/Unfunded
Name [3] 300586 0
Dr Erin McMeniman
Country [3] 300586 0
Australia
Primary sponsor type
Individual
Name
Dr Bradley Miller
Address
Dermatology Department
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba, ALQ, Australia
4102
Country
Australia
Secondary sponsor category [1] 298498 0
None
Name [1] 298498 0
Address [1] 298498 0
Country [1] 298498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300152 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 300152 0
Metro South Human Research Ethics Committee | Centres for Health Research
Metro South Hospital and Health Service
Level 7 TRI, 37 Kent Street WOOLLOONGABBA QLD 4102
Ethics committee country [1] 300152 0
Australia
Date submitted for ethics approval [1] 300152 0
29/03/2018
Approval date [1] 300152 0
21/06/2018
Ethics approval number [1] 300152 0
HREC/18/QPAH/182

Summary
Brief summary
Hidradenitis suppurativa (HS) is a long-term, inflammatory skin condition of unknown cause affecting the sweat/scent glands in the skin, predominantly located in the groin, axillae and under the breasts. Patients can experience painful boil-like nodules in addition to discharging wound tracts which are difficult to heal. Consequently, this HS can cause severe long-term pain in addition to serious psychological effects such as depression, anxiety and social withdrawal. HS severity is graded according to the Hurley system which calculates a grade based on the numbers of inflammatory nodules, in addition to the presence of sinus tracts and abscesses. To manage their symptoms, many patients require immunosuppressant medications and extensive surgery to remove the affected tissue. In such cases, application of topical medications as well as effective dressings can be a challenge. To date, specialised nurse-led education programs have not been trialled in cases of HS, despite their proven benefit in other dermatological conditions. This pilot study aims to evaluate the efficacy of a personalised dermatology-led education program for patients with hidradenitis suppurativa.

Participants will be allocated randomly using a randomisation sequence generated by Microsoft Excel using random block sizes of two (2). Randomisation and allocation of participants will be performed by the dermatology nurse who will be administering the education sessions.
Allocations will be concealed from the researchers who will be analysing the collected data.
Participants allocated to the intervention group will be provided with the education session whilst participants allocated to the control session will not receive any additional education. At the 8-week mark of the project, the groups will switch so that the participants initially allocated to the control group will then be provided with the education session. Nil further education sessions will be provided to the (original) intervention group.
Intervention:
The intervention employed in this project is a nurse-led education session provided by a highly experienced dermatology clinical nurse, to take place in the dermatology outpatient department at Princess Alexandra Hospital.
The sessions will be individualised to each participant but, in general, will provide education about:
• The nature of the condition
• Effective application of topical medications and dressings (with demonstration)
• Modification of lifestyle factors known to contribute to hidradenitis suppurativa severity (eg weight loss and smoking cessation)
• Pain management
Each session will take an estimated 45-60 minutes and participants will be offered the opportunity to contact the dermatology nurse 4-6 weeks later to address any questions or concerns that have arisen.
The sessions will not be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82714 0
Dr Bradley Miller
Address 82714 0
Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 82714 0
Australia
Phone 82714 0
+61731762882
Fax 82714 0
+61731767344
Email 82714 0
[email protected]
Contact person for public queries
Name 82715 0
Bradley Miller
Address 82715 0
Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 82715 0
Australia
Phone 82715 0
+61731762882
Fax 82715 0
+61731767344
Email 82715 0
[email protected]
Contact person for scientific queries
Name 82716 0
Bradley Miller
Address 82716 0
Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102
Country 82716 0
Australia
Phone 82716 0
+61731762882
Fax 82716 0
+61731767344
Email 82716 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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