Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial.

Area of Science:

• Clinical Trials
• Health Services Research
• Rare Diseases

Background:

• Hereditary angioedema (HAE) attacks pose significant morbidity and mortality risks despite existing treatment guidelines.
• HAE attacks represent a substantial medical challenge and socio-economic burden.
• Current management strategies for HAE attacks require optimization.

Purpose of the Study:

• To evaluate the effectiveness of a dedicated call centre in managing hereditary angioedema (HAE) attacks.
• To compare the morbidity and socio-economic costs of call centre management versus usual practice for HAE attacks.
• To determine if a call centre can reduce hospital admissions for HAE patients.

Main Methods:

• Prospective, cluster-randomised, single-blind, parallel-group, multicentre trial.
• Recruitment of 200 patients with HAE.
• Intervention arm: patients receive an SOS-HAE card for a dedicated call centre providing expert advice and facilitating timely treatment or emergency service referral.

Main Results:

• Primary outcome: number of hospital admissions for HAE attacks.
• Secondary outcomes: socio-economic costs associated with HAE attack management.
• Follow-up duration: 2 years per patient, with assessments every 2 months.

Conclusions:

• The SOS-HAE protocol aims to improve home management of HAE attacks.
• The trial will ascertain if a dedicated call centre reduces HAE attack-related hospital admissions.
• Results are expected to inform healthcare services and patients about reduced socio-economic impacts.