NCT05683847

Brief Summary

In December 2019 Vestre Viken Hospital Trust implemented user controlled epilepsy follow-up. Patients receive follow-up questions digitally twice yearly. The questionnaire was made by a multidisciplinary national network of epilepsy experts (EpilepsiNett). Responses to the questionnaire are controlled by an epilepsy nurse, and further follow-up is based on this. Data collected for user controlled follow-up will be matched with data from national registries, investigating whether this type of follow-up influences the patients' clinical course and/or the hospital's and society's use of resources.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

4.1 years

First QC Date

January 4, 2023

Last Update Submit

January 16, 2023

Conditions

Keywords

epilepsypatient reported outcome measuresPROMoutpatient follow-up

Outcome Measures

Primary Outcomes (2)

  • Number of visits to the outpatient clinic before and after implementation of user controlled epilepsy follow-up

    We hypothesize a decline in outpatient clinic visits for the people enrolled in user controlled epilepsy follow-up

    2 years

  • Number of emergency hospitalizations before and after implementation of user controlled epilepsy follow-up

    We hypothesize a decline in emergency hospitalization for the people enrolled in user controlled epilepsy follow-up

    2 years

Study Arms (1)

Adults with epilepsy

User controlled epilepsy follow-up by means of digital patient reported outcome measures (PROM).

Other: User controlled epilepsy follow-up by means of patient reported outcome measures (PROM)

Interventions

Whenever they want to, but minimum every six months, users respond to standardized follow-up questions developed by the experts of EpilepsiNett. This ensures that a broader range of topics are covered, not just those related to seizures and adverse events. The incoming responses are handled by a trained epilepsy nurse, who contact the patient when needed, consulting the responsible medical doctor when needed. If current issues cannot be solved by telephonic contact with the epilepsy nurse and/or responsible medical doctor, the patient is offered an appointment at the outpatient clinic.

Adults with epilepsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults with a diagnosis of epilepsy visiting the outpatient clinic or the Dep. of Neurology in Vestre Viken Hospital Trust.

You may qualify if:

  • Diagnosis of epilepsy. Age\>18 years.

You may not qualify if:

  • Not able to handle the digital tools required for this type of follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drammen Hospital

Drammen, 3004, Norway

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Marte Syvertsen, PhD

    Vestre Viken Hospital Trust

    STUDY CHAIR

Central Study Contacts

Marte Syvertsen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

December 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations