ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Seizures

Condition category

Condition code

Neurological

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]

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]

Quality of life, as measured by EQ-5D and QoLIE-31

Timepoint [1]

At time of initial first seizure clinic appointment (primary timepoint), 6 months and 12 months.

Primary outcome [2]

Effect of seizure on work productivity, as measured by WPAI

Timepoint [2]

At time of initial first seizure clinic appointment (primary timepoint), 6 months and 12 months.

Primary outcome [3]

Effect of first seizure on Informal Care Needs, as measured by the Informal Care Needs questionnaire

Timepoint [3]

At time of initial first seizure clinic appointment (primary timepoint), and 6- and 12-months.

Secondary outcome [1]

Indirect costs of first seizures will be assessed in terms of economic impact, derived from effect on work productivity, via WPAI.

Timepoint [1]

At time of initial first seizure clinic appointment and 6- and 12-months.

Secondary outcome [2]

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]

At time of initial first seizure clinic appointment and 6- and 12-months.

Secondary outcome [3]

Effect of first seizure on self-rated anxiety and depression, as rated by the Hospital Anxiety and Depression Scale (HADS).

Timepoint [3]

At time of initial first seizure clinic appointment, 6 months and 12 months.

Secondary outcome [4]

Assess out of pocket costs of first seizure (e.g., attending hospital, clinic appointments, medications) via the Out of Pocket Costs questionnaire.

Timepoint [4]

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?

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]

The Alfred - Melbourne

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Box Hill Hospital - Box Hill

Recruitment hospital [4]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [5]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3050 - Parkville

Recruitment postcode(s) [3]

3128 - Box Hill

Recruitment postcode(s) [4]

3084 - Heidelberg

Recruitment postcode(s) [5]

3065 - Fitzroy

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded - Investigator initiated

Address [1]

Dr Emma Foster
Central Clinical School, Monash University
Level 6, 99 Commercial Road, Melbourne VIC 3000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health

Ethics committee address [1]

55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/08/2019

Approval date [1]

14/02/2020

Ethics approval number [1]

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

A/Prof Zanfina Ademi

Address

School of Public Health and Preventive Medicine
553 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61399030444

Fax

[email protected]

Contact person for public queries

Name

Emma Foster

Address

Central Clinical School
Monash University
Level 6, 99 Commercial Road,
Melbourne VIC 3004

Country

Australia

Phone

+61390762497

Fax

[email protected]

Contact person for scientific queries

Name

Emma Foster

Address

Central Clinical School
Monash University
Level 6, 99 Commercial Road,
Melbourne VIC 3004

Country

Australia

Phone

+61390762497

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Prospective multisite cohort study of patient-reported outcomes in adults with new-onset seizures.	2022	https://dx.doi.org/10.1002/epi4.12571

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically