Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000908831
Ethics application status
Approved
Date submitted
20/10/2020
Date registered
13/07/2021
Date last updated
16/01/2024
Date data sharing statement initially provided
13/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
First seizures in adults: multicentre longitudinal study of patient reported outcome measures
Scientific title
Examining patient quality of life and impact of seizures on work productivity in adults attending a first epileptic seizure clinic
Secondary ID [1] 302564 0
None
Universal Trial Number (UTN)
U1111-1259-8466
Trial acronym
First Seizure PROMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 319443 0
Seizures 319444 0
Condition category
Condition code
Neurological 317412 317412 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To collect patient-reported data regarding work, mood, quality of life, and decisions regarding antiseizure medication adherence, for patients with new-onset seizures. Data is collected at initial first seizure clinic visit, then at 6- and 12-month time points.

- Participants will complete the following questionnaires regarding their first seizure experience: EQ5D, Work Productivity Activity Impairment (WPAI), Informal care needs questionnaire, QoLIE-31, Hospital anxiety and depression scale, Out of pocket costs questionnaire, Treatment gap questionnaire

- Participants will be asked to complete each of the questionnaires described above. It is anticipated this will take 20 minutes over a single session. This will be done at baseline (initial first seizure clinic appointment, if it is within 6 weeks of the index seizure event, and then 6- and 12-months later.

- These assessments will be delivered securely online via REDCap questionnaires.

- These assessments will be self-directed; i.e., participants will self-complete these questionnaires.
Intervention code [1] 318852 0
Not applicable
Comparator / control treatment
The patient reported outcome measures will be compared between patients with a first seizure (both unprovoked and acute symptomatic seizures) and two comparator groups: psychogenic non-epileptic seizures (comparator group 1), and syncope (comparator group 2).
Control group
Active

Outcomes
Primary outcome [1] 325442 0
Quality of life, as measured by EQ-5D and QoLIE-31
Timepoint [1] 325442 0
At time of initial first seizure clinic appointment (primary timepoint), 6 months and 12 months.
Primary outcome [2] 325444 0
Effect of seizure on work productivity, as measured by WPAI
Timepoint [2] 325444 0
At time of initial first seizure clinic appointment (primary timepoint), 6 months and 12 months.
Primary outcome [3] 327852 0
Effect of first seizure on Informal Care Needs, as measured by the Informal Care Needs questionnaire
Timepoint [3] 327852 0
At time of initial first seizure clinic appointment (primary timepoint), and 6- and 12-months.
Secondary outcome [1] 387978 0
Indirect costs of first seizures will be assessed in terms of economic impact, derived from effect on work productivity, via WPAI.
Timepoint [1] 387978 0
At time of initial first seizure clinic appointment and 6- and 12-months.
Secondary outcome [2] 387980 0
Assess factors contributing to ‘treatment gap’, ie) delayed initiation of antiepileptic drugs for those with new diagnosis epilepsy, via the 'Treatment Gap Questionnaire'
Timepoint [2] 387980 0
At time of initial first seizure clinic appointment and 6- and 12-months.
Secondary outcome [3] 396785 0
Effect of first seizure on self-rated anxiety and depression, as rated by the Hospital Anxiety and Depression Scale (HADS).
Timepoint [3] 396785 0
At time of initial first seizure clinic appointment, 6 months and 12 months.
Secondary outcome [4] 396786 0
Assess out of pocket costs of first seizure (e.g., attending hospital, clinic appointments, medications) via the Out of Pocket Costs questionnaire.
Timepoint [4] 396786 0
At time of initial first seizure clinic appointment, 6 months and 12 months.

Eligibility
Key inclusion criteria
- Aged 18 or over
- Attendance to Alfred Health, The Royal Melbourne Hospital, Austin Hospital, Box Hill Hospital, St Vincent's Hospital, or University of Colorado Hospital First Seizure Clinics via Telehealth, telephone, or in person.
- Study group: those with first-ever unprovoked and acute symptomatic seizures.
- Comparison group #1: Psychogenic non-epileptic seizures
- Comparison group #2: Syncope
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Aged 17 or less
- Pre-existing epilepsy diagnosis

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
• Repeated measures analysis using linear mixed models will be used to assess differences in the baseline, 6 and 12 months (change in quality of life, work productivity, and informal care).
• Health Related quality of life will be assessed by generic (5-level EuroQoL Group’s 5-dimension (EQ-5D-5L) and disease specific (QoLIE-31). The EQ-5D-5L is a simple, generic measure of five dimensions of health for economic appraisal: mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus overall self-rated health. The self-rated EQ-5D-5L provides a basis for calculating preference-based health related quality of life and for calculating QALY and for conducting cost-utility analysis in economic evaluations. A valuation algorithm for EQ-5D- 5L is required to generate utility values for the estimation of QALYs. The cross value sets are available for EQ-5D-3L and will be adapted to fit the EQ-5D-5L descriptive system. Where genuine valuation algorithms for the EQ-5D-5L are still missing, interim (crosswalk) value sets, as mention above, will be used.
• Indirect costs of loss of production due to first seizure-related absence from work, or days of inactivity, will be included, using Work Productivity Activity Index (WPAI) questionnaire. Informal carer involvement in care data will be collected using two questions from the Optimising Therapy to Prevent Avoidable Hospital Admissions in the Multi-Morbid Older People: cluster randomised controlled trial (OPERAM-Health economic sub-study). Additionally, we will explore four models to generate value sets for the EQ-5D-5L: linear regression, nonparametric statistics, ordered logistic regression, and item-response theory. We note that nonparametric models have shown a better ability to estimate 5L value sets by using any 3L value set.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
450
Accrual to date
250
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17838 0
The Alfred - Melbourne
Recruitment hospital [2] 17839 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 17840 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 17841 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 19734 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 31694 0
3004 - Melbourne
Recruitment postcode(s) [2] 31695 0
3050 - Parkville
Recruitment postcode(s) [3] 31696 0
3128 - Box Hill
Recruitment postcode(s) [4] 31697 0
3084 - Heidelberg
Recruitment postcode(s) [5] 34373 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 23777 0
United States of America
State/province [1] 23777 0
CO

Funding & Sponsors
Funding source category [1] 306997 0
Self funded/Unfunded
Name [1] 306997 0
Unfunded - Investigator initiated
Country [1] 306997 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Central Clinical School
Level 6, 99 Commercial Road
Melbourne VIC 3000
Australia
Country
Australia
Secondary sponsor category [1] 307562 0
None
Name [1] 307562 0
Address [1] 307562 0
Country [1] 307562 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307129 0
Alfred Health
Ethics committee address [1] 307129 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 307129 0
Australia
Date submitted for ethics approval [1] 307129 0
29/08/2019
Approval date [1] 307129 0
14/02/2020
Ethics approval number [1] 307129 0
SERP: 52538, Alfred HREC: 307/19

Summary
Brief summary
The health economic impact of epilepsy is well-studied, but similar data is lacking for first seizures. First seizures are a common and important neurological disorder, with unprovoked seizures affecting up to 10% of people and acute symptomatic seizures affecting over 3% of people during a lifetime. Establishing the true cost of first seizures is important to fully appreciate their substantial impact on patients, care-givers and society. Some data exists on the direct medical costs of first seizures, that is, the cost of health care utilisation, including hospitalisation, outpatient appointments, investigations and antiepileptic drugs. Far less studied is the indirect costs of seizures and the effect of seizures on patients’ quality of life. We propose to do this by measuring work productivity activity index (WPAI) through absenteeism, presenteeism and early retirement, and informal care needs. Additionally, patient reported outcome measures (PROMS) through validated quality of life surveys including EQ-5D, QoLIE-31 will be collected. In applicable cases, we will consider the reasons guiding initiation of antiepileptic drugs, both from clinicians’ and patients’ perspectives. People with epilepsy have a far higher prevalence of mood disorders compared to the general population. Screening for depression and anxiety via the Hospital Anxiety and Depression Scale (HADS) will help determine the onset of these disorders relative to the onset of the first seizure, and if the patients later develop epilepsy, provide a baseline measure of mood disorders to compare with subsequent evaluations. Flagging mood disorders as early as First Seizure Clinic will also promote earlier diagnosis and management, and this is an important part of providing holistic and comprehensive care. By adding indirect cost data and quality of life data to the literature, we hope to more comprehensively capture the true societal burden of first seizures, as well as to prospectively study the reasons behind decision to initiate or defer antiepileptic drug therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106134 0
A/Prof Zanfina Ademi
Address 106134 0
School of Public Health and Preventive Medicine
553 St Kilda Rd
Melbourne VIC 3004
Country 106134 0
Australia
Phone 106134 0
+61399030444
Fax 106134 0
Email 106134 0
[email protected]
Contact person for public queries
Name 106135 0
Dr Emma Foster
Address 106135 0
Central Clinical School
Monash University
Level 6, 99 Commercial Road,
Melbourne VIC 3004
Country 106135 0
Australia
Phone 106135 0
+61390762497
Fax 106135 0
Email 106135 0
[email protected]
Contact person for scientific queries
Name 106136 0
Dr Emma Foster
Address 106136 0
Central Clinical School
Monash University
Level 6, 99 Commercial Road,
Melbourne VIC 3004
Country 106136 0
Australia
Phone 106136 0
+61390762497
Fax 106136 0
Email 106136 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


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
SourceTitleYear of PublicationDOI
EmbaseProspective multisite cohort study of patient-reported outcomes in adults with new-onset seizures.2022https://dx.doi.org/10.1002/epi4.12571
N.B. These documents automatically identified may not have been verified by the study sponsor.