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Trial registered on ANZCTR


Registration number
ACTRN12623000158662
Ethics application status
Approved
Date submitted
31/01/2023
Date registered
16/02/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
16/02/2023
Date results information initially provided
28/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the IMpact of Alopecia Areata (AA) on PatIents’ and CaregiverS’ in Australia (MARISSA)
Scientific title
Assessing the IMpact of Alopecia Areata (AA) on PatIents’ and CaregiverS’ in Australia (MARISSA)
Secondary ID [1] 308869 0
B7981083
Universal Trial Number (UTN)
Trial acronym
MARISSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia Areata 328858 0
Condition category
Condition code
Inflammatory and Immune System 325855 325855 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is an observational study with no treatment intervention.
Data will be collected through a one-time cross-sectional survey (one timepoint)
The survey will use online screening questions to verify participants’ eligibility and invite potential participants to take part in the study by completing bespoke questionnaires. Caregivers can also opt in their dependant (12-17 years of age) to participate.
Recruitment is expected to take eight weeks (starting in March 2023) to reach the sample size. Invitation to participate is going to be done by the AAAF (Alopecia Areata Australian Foundation) online channels.
The survey takes 30 minutes to complete.

The following variables are going to be collected per participant:

1) Adult patient questionnaire
The survey will collect information on the following from adult patients with AA:
Socio-demographic characteristics (for adolescent respondents, this information will
be provided by the caregiver):
Age;
Sex;
Race and ethnicity;
Highest level of education completed;
Employment status;
State of residence;
Household income in the previous year.
Bank account details
AA Medical history. (eg, symptoms onset, medically confirmed diagnosis, family
history)
Experience with AA;
Treatment.
Self-reported satisfaction with treatment.
Coping mechanisms.
Impact of AA on work
Scalp Hair Assessment PRO™.
AAPPO;
AASIS
WPAI/WPAI+CIQ;
HADS.

2) Dependant adolescent patient questionnaire
The survey will collect information on the following from adolescent patients with AA:
AA Medical history (eg, symptoms onset, medically confirmed diagnosis, family
history);
Experience with AA;
HRQoL.
Scalp Hair Assessment PRO™.
AAPPO;
WPAI/WPAI+CIQ;
HADS.

3) Caregiver survey

a) Dyadic caregivers’ questionnaire
For caregivers of adolescents who will participate in the survey, the survey will collect the
following information:
Caregiver socio-demographics:
Age;
Sex;
Race and ethnicity;
Highest level of education completed;
Employment status;
State of residence;
Household income in the previous year.
Bank account details
Relationship with the AA adolescent;
Socio-demographic characteristics of AA adolescent;
Age;
Sex;
Race and ethnicity;
Highest level of education completed;
Employment status;
State of residence;
Household income in the previous year.
Treatment (same variables as in the patient survey);
Caregiver’s experience with adolescent’s AA;
Caregiver’s treatment to cope with adolescent’s AA;
Impact of adolescent’s AA on caregiver’s work.
HRQoL:
WPAI/WPAI+CIQ;
HADS
QLCCDQ

b) Non-dyadic caregivers’ questionnaire
For caregivers of adolescents who refuse or are unable to participate in the survey, the
following information will be collected, in addition to the dyadic caregivers’ survey:
AA Medical history. (eg, symptoms onset, medically confirmed diagnosis, family
history)
Experience with AA (same variables as in the patient survey);
Intervention code [1] 325312 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333683 0
Severity of Alopecia Areata among patients assessed using Scalp Hair Assessment PRO™ validated instrument.
Timepoint [1] 333683 0
Point in time for participants recruited over 8 weeks
Primary outcome [2] 333855 0
Impact of Alopecia Areata among patients assessed using AAPPO validated instrument
Timepoint [2] 333855 0
Point in time for participants recruited over 8 weeks
Primary outcome [3] 333856 0
Symptoms of Alopecia Areata among adult patients assessed using AAPPO validated instrument.
Timepoint [3] 333856 0
Point in time for participants recruited over 8 weeks
Secondary outcome [1] 417941 0
Describe socio-demographic and clinical characteristics of patients with AA assessed using socio-demographic characteristic bespoke survey developed for the study.
Timepoint [1] 417941 0
Point in time for participants recruited over 8 weeks
Secondary outcome [2] 418112 0
Describe socio-demographic and clinical characteristics of caregivers of adolescents 12 to 17 years of age with AA assessed using socio-demographic characteristic bespoke survey developed for the study.
Timepoint [2] 418112 0
Point in time for participants recruited over 8 weeks
Secondary outcome [3] 418486 0
PRIMARY OUTCOME
Depression and anxiety among Alopecia Areata patients assessed using HADS validated instrument.
Timepoint [3] 418486 0
Point in time for participants recruited over 8 weeks
Secondary outcome [4] 418487 0
PRIMARY OUTCOME
Productivity Alopecia Areata patients assessed using WPAI+CIQ validated instrument.
Timepoint [4] 418487 0
Point in time for participants recruited over 8 weeks
Secondary outcome [5] 418488 0
PRIMARY OUTCOME
Impact of dependent's Alopecia Areata on parental perception of health outcomes using QLCCDQ validated instrument.
Timepoint [5] 418488 0
Point in time for participants recruited over 8 weeks.

Eligibility
Key inclusion criteria
Patient survey
• Self-reported medically confirmed diagnosis of AA for at least 3 months before the survey completion date (assessed via online screener)
• For adolescents aged 12-17 years old, consent from parents/guardians and assent from the patients (assent form 12-14 years and 15-17 years) will be required, this will be obtained sequentially).

Caregiver survey
• Parent or legal guardian of a patient aged 12-17 years with self-reported medically confirmed diagnosis of AA for at least 3 months before the survey completion date
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a medical diagnosis of any form of cancer in the past 5 years or with a medical diagnosis of androgenetic alopecia (AGA) and patient or dependant with a self-reported medically confirmed diagnosis of AA for less than 3 months before the survey completion date
Adolescents can only participate if caregiver has provided contact details on adolescent behalf

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis plan will be delivered once final ethics approval has been given and recruitment has commenced. Summary statistics will be developed for both entire patient sample and caregiver sample separately. Means, medians, minimum/maximum and SDs will be reported for continuous characteristics and frequency counts and percentages will be reported for categorical variables.
A copy of summary statistics will be provided to participants following the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/04/2023
Actual
27/04/2023
Date of last participant enrolment
Anticipated
28/06/2023
Actual
26/07/2023
Date of last data collection
Anticipated
28/06/2023
Actual
27/07/2023
Sample size
Target
400
Accrual to date
Final
428
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313089 0
Commercial sector/Industry
Name [1] 313089 0
Pfizer Australia Pty Ltd
Country [1] 313089 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Pfizer Australia Pty Ltd
Address
51, Barrack Place, Clarence Street, Sydney, 2000, NSW, Australia
Country
Australia
Secondary sponsor category [1] 314779 0
None
Name [1] 314779 0
Address [1] 314779 0
Country [1] 314779 0
Other collaborator category [1] 282533 0
Commercial sector/Industry
Name [1] 282533 0
IQVIA Solutions Pty Ltd
Address [1] 282533 0
Level 8, 201 Pacific Highway
St Leonards NSW 2065
Country [1] 282533 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312334 0
Bellberry Limited
Ethics committee address [1] 312334 0
123 Glen Osmond Rd, Eastwood SA 5063
Ethics committee country [1] 312334 0
Australia
Date submitted for ethics approval [1] 312334 0
29/11/2022
Approval date [1] 312334 0
30/03/2023
Ethics approval number [1] 312334 0
2022-11-1301

Summary
Brief summary
This is a one-time cross-sectional, online study, consisting in a patient survey and a patient caregiver survey. Adult and adolescent patients with AA, and the caregivers of adolescent AA patients (dyadic and non-dyadic caregivers), will be recruited to participate in the survey. The surveys will assess the psychosocial and life impacts and disease burden associated with AA.
In order to increase sample size for the caregiver survey, caregivers will be allowed to participate in the survey even if their dependant adolescent with AA refuses or is unable to participate (ie, non-dyadic caregiver). Additional information about the adolescent with AA will be provided by the non-dyadic caregiver compared to the dyadic caregiver.
The survey will use online screening questions to verify participants’ eligibility and invite potential participants to take part in the study.
After consenting, data will be collected in the patient survey via a bespoke questionnaire on patient/caregiver characteristics (e.g., age, sex, socioeconomic status, race, and ethnicity), self-reported medical and treatment history, satisfaction with treatment, and validated instruments on disease severity and impact, psychosocial disorders, disease specific quality of life, and work and classroom productivity and impairment.

IQVIA will collaborate with the Alopecia Areata Australia Foundation (AAAF) to recruit eligible patients with AA and caregivers, defined by inclusion and exclusion criteria below. The AAAF has nationally representative sample of AA patients and caregivers in their network. Participants will be invited to participate online via the AAAF’s closed Facebook page via post and via the AAAF newsletter distributed by email among AAAF registrants. until the sample size is met.
AAAF was founded in 2010 with the purpose of improving the lives of people living with AA and their families in Australia.
Recruitment is expected to last 8 weeks or until recruitment target is reached.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124294 0
Mrs Maureen Hitschfeld
Address 124294 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124294 0
Australia
Phone 124294 0
+61423641270
Fax 124294 0
Email 124294 0
[email protected]
Contact person for public queries
Name 124295 0
Maureen Hitschfeld
Address 124295 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124295 0
Australia
Phone 124295 0
+61423641270
Fax 124295 0
Email 124295 0
[email protected]
Contact person for scientific queries
Name 124296 0
Maureen Hitschfeld
Address 124296 0
IQVIA Solutions Australia Pty Ltd, Level 8, 141 Walker Street North Sydney NSW 2060 Australia
Country 124296 0
Australia
Phone 124296 0
+61423641270
Fax 124296 0
Email 124296 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
No IPD will be publicly available.


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.