Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000599673
Ethics application status
Approved
Date submitted
8/03/2023
Date registered
1/06/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
1/06/2023
Date results information initially provided
4/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of SERIAS: Seizure-Related Impact Assessment Scale
Scientific title
Validation of SERIAS: Seizure-Related Impact Assessment Scale
Secondary ID [1] 309143 0
Nil known
Secondary ID [2] 310696 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SERIAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 329244 0
Condition category
Condition code
Neurological 326202 326202 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
People living with epilepsy will prospectively be enrolled to take part in this study when they attend the hospital epilepsy service (e.g., elective hospital admission to the epilepsy ward, or routine epilepsy outpatient appointment). The study involves completing up to 9 short questionnaires regarding the effect of epilepsy on their work, quality of life, and mood, plus the study questionnaire (SERIAS). Researchers will compare how well SERIAS tracks and measures change compared to existing questionnaires. The questionnaires may be completed online or on paper. They will take around 20 minutes to complete. Participants are then invited to complete the same questionnaires again, 3- and 6-months later. Researchers will also review participant's medical records to mark down the type of epilepsy a person has, how frequently they have seizures, and their current treatment at each time point to see how changes in their underlying epilepsy and treatment translate to changes in their SERIAS responses.

In addition, a subgroup of people will be invited to complete questionnaires at an additional time point, two weeks prior to taking the full-set of baseline questionnaires. The responses from this subgroup with help researchers confirm the test-retest reliability of SERIAS.
Intervention code [1] 325592 0
Not applicable
Comparator / control treatment
All patients enrolled in the study will be administered the same questionnaires for validation of the SERIAS. Covariables, including age, sex, epilepsy type, seizure frequency, antiseizure medication regimen, concomittant mood disorders, will be adjusted for in the analysis.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334078 0
Seizure-related impact as measured by SERIAS
Timepoint [1] 334078 0
Completion of study
Primary outcome [2] 334236 0
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) mean depression score
Timepoint [2] 334236 0
Completion of study
Primary outcome [3] 334237 0
Mean health-related quality of life scores, as measure by a validated epilepsy-specific QoL instrument, the QoLIE-89 and/or -31
Timepoint [3] 334237 0
Completion of study
Secondary outcome [1] 419290 0
Mean antiseizure medication side effect score, as measured by a validated epilepsy-specific instrument, the Liverpool Adverse Events Profile (LAEP).
Timepoint [1] 419290 0
Completion of study
Secondary outcome [2] 422399 0
PRIMARY OUTCOME: Treatment-related impact as measured by SERIAS
Timepoint [2] 422399 0
PRIMARY TIMEPOINT: Completion of study
Secondary outcome [3] 422400 0
PRIMARY OUTCOME: Generalised Anxiety Disorder-7 (GAD-7) mean anxiety score
Timepoint [3] 422400 0
PRIMARY TIMEPOINT: Completion of study
Secondary outcome [4] 422401 0
PRIMARY OUTCOME: Mean health-related quality of life scores, as measure by a validated generic QoL instrument, the EQ5D
Timepoint [4] 422401 0
PRIMARY TIMEPOINT: Completion of study

Eligibility
Key inclusion criteria
- Adults aged 18 years and over with confirmed epilepsy and without PNES
- Able to read and comprehend questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- People aged less than 18 at time of study
- Co-existing intellectual disability that would preclude people from comprehending and completing questionnaires
- Limited English reading proficiency that would preclude people from comprehending and completing questionnaires
- In catatonic / floridly psychotic / post-ictal state at time of questionnaire administration.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Bivariate correlation coefficients between the SERIAS and other relevant instruments will be computed. Psychometric reliability will be computed in the form of Cronbach’s alpha and McDonald’s omega coefficients. Test-retest reliability will be examined using bivariate correlation coefficients between time 1 and time 2.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/03/2023
Date of last participant enrolment
Anticipated
Actual
1/09/2023
Date of last data collection
Anticipated
Actual
13/03/2024
Sample size
Target
50
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313344 0
Commercial sector/Industry
Name [1] 313344 0
LivaNova
Country [1] 313344 0
United States of America
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 315092 0
None
Name [1] 315092 0
Address [1] 315092 0
Country [1] 315092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312566 0
Alfred Health Ethics Committee
Ethics committee address [1] 312566 0
55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 312566 0
Australia
Date submitted for ethics approval [1] 312566 0
Approval date [1] 312566 0
02/03/2023
Ethics approval number [1] 312566 0

Summary
Brief summary
This multisite prospective study will validate the SERIAS (Seizure-Related Impact Assessment Scale) for use in clinical epilepsy research and practice. 50 adult patients attending the Comprehensive Epilepsy Centres at The Alfred and The Royal Melbourne Hospital in Melbourne, Australia, will be consented and enrolled in the study. Participants will complete the novel SERIAS instrument, and a battery of validated instruments to assist with validation. These questionnaires will be completed at baseline, 3-, and 6-month timepoints. A subgroup will also form a test-retest cohort, repeating the instruments within a 2 week period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125114 0
Dr Emma Foster
Address 125114 0
Monash University, Central Clinical School, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 125114 0
Australia
Phone 125114 0
+61 390762497
Fax 125114 0
Email 125114 0
emma.foster@monash.edu
Contact person for public queries
Name 125115 0
Ms Alison Conquest
Address 125115 0
Monash University Central Clinical School, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 125115 0
Australia
Phone 125115 0
+61 390762497
Fax 125115 0
Email 125115 0
alison.conquest@monash.edu
Contact person for scientific queries
Name 125116 0
Ms Alison Conquest
Address 125116 0
Monash University Central Clinical School, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 125116 0
Australia
Phone 125116 0
+61 390762497
Fax 125116 0
Email 125116 0
alison.conquest@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This dataset will contain sensitive health information. Use outside this SERIAS study is not permitted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.