ANZCTR - Registration

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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]

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

Condition category

Condition code

Skin

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]

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]

Change in self-management and empowerment as measured by the HEIQ score

Timepoint [1]

1. 8 weeks post-randomisation
2. 16 weeks post-randomisation

Primary outcome [2]

Change in quality of life as assessed by the DLQI score

Timepoint [2]

1. 8 weeks post-randomisation
2. 16 weeks post-randomisation

Secondary outcome [1]

Quantity of medications used as recorded in patient diaries

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Bradley Miller

Address [1]

Dermatology Department
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba, ALQ, Australia
4102

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Dermatology Dept

Address [2]

Building 7
199 Ipswich Road,
Woolloongabba QLD, Australia
4102

Country [2]

Australia

Funding source category [3]

Self funded/Unfunded

Name [3]

Dr Erin McMeniman

Address [3]

Dermatology Department
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba, ALQ, Australia
4102

Country [3]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro South Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

29/03/2018

Approval date [1]

21/06/2018

Ethics approval number [1]

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

Dr Bradley Miller

Address

Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731762882

Fax

+61731767344

bradleymiller026@gmail.com

Contact person for public queries

Name

Bradley Miller

Address

Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731762882

Fax

+61731767344

bradleymiller026@gmail.com

Contact person for scientific queries

Name

Bradley Miller

Address

Dermatology Department
Building 7, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba
QLD 4102

Country

Australia

Phone

+61731762882

Fax

+61731767344

bradleymiller026@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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