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The effectiveness and cost-effectiveness of seizure dogs

The effectiveness and cost-effectiveness of seizure dogs

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26140
Enrollment
35
Registered
2017-11-28
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory epilepsy Drug-resistant epilepsy Refractaire epilepsie Therapieresistente epilepsie

Interventions

The intervention consists of seizure dogs. The training of these dogs focuses on responding to seizures during or immediately after an epileptic seizure occurs in their human companion. Seizure dogs

Sponsors

Erasmus School of Health Policy and Management institute for Medical Technology Assessment
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Confirmed diagnosis of epilepsy by neurologist with video or EEG confirmation; - Seizures have to be proven epileptic (exclusion of patients with only or mostly psychogenic non-epileptic seizures); - Refractory epilepsy/medication resistant epilepsy (persistent seizures despite the use of at least two AEDs in monotherapy or combination); - Not eligible for epilepsy surgery (or when epilepsy surgery has not resulted in seizure freedom); - Average seizure frequency of at least 2 per week with a maximum seizure free period of 2 weeks (in last 6 months); - High potential risk of injury due to: i) Lack of warning signals prior to seizure (aura); and/or ii) Reduced awareness; and/or iii) Loss of balance; - Minimum age of 18 years old (able to handle the responsibility for taking care of the dog); - Cognitive able to take care of the dog adequately and fill in questionnaire/seizure diary independently (minimum IQ of 70 recommended); - There must be adequate support in the patient’s environment to ensure that the dog’s needs can be met

Exclusion criteria

Exclusion criteria: - Institutionalized; - Currently in possession of a trained epilepsy dog; - Recipient or primary caregivers of recipient are allergic to dogs; - Intention to undergo Nervus Vagus Stimulation or to follow a ketogenic diet during the duration of the study.

Design outcomes

Secondary

MeasureTime frame
Besides the primary outcome measure, the impact of seizure dogs on seizure severity, well-being, health-related quality of life, productivity costs and healthcare resource use (both formal and informal care) will be evaluated.

Primary

MeasureTime frame
The primary outcome of the study will be seizure frequency.

Contacts

Public ContactValérie Wester

Erasmus School of Health Policy and Management

wester@eshpm.eur.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)