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EpilepsyNCT03655366

Epidogs International Inventory of Seizure Alert Dogs

An observational study of Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This international research project looks at the reliability of canine seizure alerting behaviour in epilepsy patients. In the first stage an international database to identify the size and composition of the population of seizure alerting dogs has been created. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
Questionnaire for Dog owners and Questionnaire for Dog trainers
How many people
227 participants
Where
1 siteBelgium
Study dates
1 Sep 2017to 1 Jul 2018
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Dog owners (adults and children) with epilepsy

Who may be able to join

  • Adults ( >18 years) diagnosed with epilepsy who live with a dog
  • Children (< 18 years) that have been diagnosed with epilepsy and live with a dog; represented by the parents
  • Epilepsy patients with intellectual disabilities that live with a dog; represented by their legal representative

Who cannot join

  • Participants or their representative must be able to answer questions using our online questionnaire. They must sign the inform consent to access the questionnaire.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Department of Neurology - Ghent University Hospital

    Ghent, Flanders, 9000

Other trials in Belgium

About this study

Official title: Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part 1:International Inventory of Seizure Dogs

This international research project looks at the reliability of canine seizure alerting behaviour in epilepsy patients. In the first stage an international database to identify the size and composition of the population of seizure alerting dogs has been created.

Read the detailed description

The size and composition of the population of seizure alerting dogs is still widely unknown, particularly the population of non-trained alerting dogs. Previously published studies have focused on anecdotal reports, single case studies, or small samples of the population. Some studies do not make a clear distinction between response and alert dogs and/or include only one type of alerting dogs. The objective of this study is to create an international alerting dog database including trained Seizure Alert Dogs (SADs), spontaneously alerting Seizure Response Dogs (SRDs) and spontaneously alerting pet dogs. This information will be used to select a representative sample of the population for subsequent work packages and to perform a descriptive analysis of the population of alerting dogs in and international context. For the database, two questionnaires will be developed: one will be directed to SDR and SAD trainers and a second one to epilepsy patients owning a dog.

Questionnaires

The Trainer Questionnaire will be sent to training organisations via email and will request the following information:

  • Number of active working dogs.
  • Dog demographic information and selection criteria.
  • The type of patient inclusion criteria they use
  • Training methods used.
  • For SRD that spontaneously started anticipating seizures: information about further training that may have been provided.

The questionnaire directed to epilepsy patients owning dogs will be accessible from our website and will collect the following information:

  • Demographic information
  • Information about the seizures
  • Type of dog: SAD or spontaneously alerting SRD or pet dog
  • Approximate date when the dog started alerting, if it's an untrained dog.
  • Demographic information about the dog.
  • Type of alerting behaviour.
  • Monash Canine Personality Questionnaire refined (MCPQ-R): Defines 5 traits of dog personalities.
  • The Monash Dog-Owner Relationship Scale (MDORS) ) that studies the perceived bond between the patient and the dog. It consists of 28 items with a score ranging from 1 to 5 that characterizes the emotional closeness, the dog-owner interaction and the perceive costs of dog ownership (Only for patients older than 18 year old)

Recruitment

Collaboration with epilepsy research groups has been stablished inside and outside the EU (Belgium, UK, US, Italy< Germany and Spain).

A systematic online search was performed to identify all SRD and SAD training organisations across the world. These organisations were contacted via email and telephone (see email example document) and asked to participate in the study by completing the trainer questionnaire and by distributing information about the study and an invitation to participate between their clients.

To reach epileptic owners of non-trained dogs that presumably alert, the following organisations were contacted:

  • Epilepsy support organizations.
  • Medical non-profit organisations
  • Social media groups and forums.
  • neurology departments and epilepsy centers

Milestones

  • To create an international database of alerting dogs (SAD and spontaneously alerting SRD and pet dogs) to be used in subsequent work packages.
  • Descriptive analysis of the population of alerting dogs and their owners.
  • A description of the human-dog relationship between epileptic patients and their dog (separated according to whether the dog is one that alerts or not). A description of "Personality traits" of alerting and non-alerting dogs.
Conditions
Epilepsy
Being tested
Questionnaire for Dog owners, Questionnaire for Dog trainers
Keywords
epilepsy, seizures, seizure alert dogs, seizure response dogs, assistance dogs
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionnaire for Dog ownersOther

    Questionnaire directed to epileptic patients, parents of epileptic children and legal representatives of epileptic patients with intellectual disabilities. It includes questions about demographics, epilepsy diagnosis, seizures, the behavior of their dogs around the time they have a seizure and a validates scale to measure dog personality traits.

  • Questionnaire for Dog trainersOther

    Questionnaire for seizure response and seizure alert dog trainers including information on number of active working dogs, dog demographic information and selection criteria, the type of patient inclusion criteria they use, training methods used.

Study groups in NCT03655366
Study groupRoleWhat they receive
Dog owners with epilepsyEpilepsy patients that own one or more dogs.
Receives: Other: Questionnaire for Dog owners
Training organisationsTrainers of seizure response and seizure alerting dogs.
Receives: Other: Questionnaire for Dog trainers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Descriptive analysis of the population of owners of alerting and non-alerting dogs

    Comparison of the responses from owners of alerting dogs and the responses of owners of non-alerting dogs in terms of type and frequency of seizures, presence or not od pre-ictal symptoms, etc.

    Measured: Until October 2020

Secondary outcomes (2)
  1. Differences in personality traits between alerting and non alerting dogs

    Differences between the scores obtained in the MCPQ-R scale by alerting and non alerting dogs

    Measured: Until October 2020

  2. Differences in human-dog bond between alerting and non alerting dogs

    Differences between the scores obtained in the MDORS scale by alerting and non alerting dogs

    Measured: Until October 2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start1 Sep 2017
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
227 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655366
Sponsor's protocol ID
EC/2017/0934
Status last verified
Aug 2018
First submitted
7 Nov 2017
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dwyer, F., Bennett, P.C., Coleman, G.J., 2006. Development of the Monash Dog Owner Relationship Scale (MDORS). Anthrozoos 19, 243-256.

  • Kirton A, Wirrell E, Zhang J, Hamiwka L. Seizure-alerting and -response behaviors in dogs living with epileptic children. Neurology. 2004 Jun 22;62(12):2303-5. doi: 10.1212/wnl.62.12.2303.

    PubMed 15210902
  • Ley, J.M., Bennett, P.C., Coleman, G.J., 2009a. A refinement and validation of the Monash Canine Personality Questionnaire (MCPQ). Appl. Anim. Behav. Sci. 116, 220-227

  • Inter-rater and test-retest reliability of the Monash Canine Personality Questionnaire-Revised (MCPQ-R)

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Descriptive analysis of the population of owners of alerting and non-alerting dogs (time frame: Until October 2020). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655366, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

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