No registrations found.
ID
Source
Brief title
Health condition
Severe asthma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient satisfaction
Secondary outcome
- Safety of home treatment
- Adherence to treatment with biologicals during self administration
- ACQ, AQLQ/EQ5D5L and Health care utilisation
- Cost-effectiveness
- Motivation and selfmanagement behaviour (PAM)
Background summary
Background
Increasing numbers of patients with severe asthma are treated with biologicals (monoclonal antibodies) (anti IL-5, anti IgE, anti IL-4/IL-13). Currently these biologicals are administrated in the hospital (day care). Recently some of the biologicals are approved for home administration. Existing research, concerning home treatment for other chronic diseases, suggests improved patient satisfaction. We aim to evaluate home treatment of biologicals for severe asthma in an observational (before-after) study in three tertiary severe asthma centres in the Netherlands.
Objective:
1.To evaluate patient experience and satisfaction in home treatment with biologicals for severe asthma compared to in hospital treatment.
2. To compare two different strategies in starting home treatment with biologicals for severe asthma.
Both groups will start treatment with biologicals in hospital day care for the first 4 months. After evaluating response to therapy;
a. group 1: Patients start direct independent self-administration at home for 8 months.
b. group 2: Patients are supported by a specialized nurse for the first 4 months of home treatment, followed by self-administration for the remaining study period.
(Reslizumab will be supported by a nurse for the complete study period, because of the intravenous administration)
2. To evaluate the efficiency of home treatment compared to in hospital treatment (based on motivation, self-management behaviour and health care utilisation of severe asthma patients and the practical feasibility and costs of the home treatment service provided by the hospitals).
All patients are trained on drug administration and observed for appropriate technique, following a standardized education protocol, before home therapy.
Study objective
Home administration of monocolonal antibodies for severe asthma improves patient satisfaction
Study design
.
Inclusion criteria
Inclusion criteria
- >18 yr
- Valid criteria for starting treatment with biologicals for severe asthma, according to international guidelines (ERS/ATS)
- Home treatment will only be started when a positive response to therapy is found, during the first evaluation after four months
Exclusion criteria
No
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7807 |
| Other | METC ZWH : METCZWH 19-030 |