Clinical trial NCT05642728: Impact of a PERsonalized CAse MAnagement Program for the Follow-up of Moderate and Severe aSTHma Patients on Exacerbations, Health Resource Use and Asthma Control: PERCASTHMA STUDY
Official title: Impact of a Personalised Tele-case Management Follow-up Programme on Asthma Control, Exacerbations and Use of Healthcare Resources in Moderate and Severe Asthmatics: PERCASTHMA Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Case Management
Telemedicine
Keywords: asthma
case manager
telemedicine
exacerbations
Lead sponsor: MurciaSalud
Sponsor class: OTHER_GOV
First posted: 2022-12-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial is to learn about the impact of the implementation of an intervention-based case management follow-up program during periods of clinical worsening or poor adherence in patients with moderate and severe asthma.

Patients will be randomized into two arms: a case management follow-up group and a control group that will follow-up according to routine care practice. A single masking (outcomes assessor) was performed. Researchers will compare the response on exacerbations, health resource use and asthma control between the two groups during a one-year follow-up. Outcomes on pulmonary function, quality of life, adherence to treatment, pulmonary inflammation parameters and systemic corticosteroid use will also be studied. Additionally, other baseline clinical characteristics and events of the previous year will be collected retrospectively for all patients.

The study was evaluated and approved by a local ethics committee.

All study participants will receive an asthma education session with review of inhaler technique and training in the use of self-management action plans. Only participants in the case management follow-up group will periodically send asthma control (ACT) and adherence (TAI) questionnaires to the case manager. If not completed, the case manager will contact the patient by telephone to determine the degree of asthma control and adherence. The case manager will also monitor the withdrawal of drugs on the electronic prescription. The patient will contact the case manager via a mobile app, phone or email if needed due to worsening symptoms or need for self-management support. With this information, the case manager will make decisions based on personalized medical instructions prepared by the pulmonologist at the baseline visit, which will be reviewed according to evolution.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Previous diagnosis of bronchial asthma according to GEMA 5.4 criteria.

  • Follow-up for at least 6 months in an asthma unit and absence of relevant uncontrolled comorbidities.
* Classified as moderate or severe asthma according to therapeutic step at the beginning of the study, as defined by GEMA 5.4.
* Signed informed consent form.

Exclusion Criteria:

* Simultaneous presence of other diseases that may simulate asthma symptoms (COPD, left heart failure, functional dyspnea/hyperventilation syndrome, inducible laryngeal obstruction...).
* Severe psychosocial problems or any other clinical situation that prevents the signature of the informed consent and/or the follow-up proposed in the study.
* Lack of minimum technological knowledge for the use of monitoring tools.

Primary outcomes:
measure: Median ACT score at 6 and 12 months compared with control group and baseline
timeFrame: At 6 and 12 months
measure: Median of total and severe exacerbations at 12 months
timeFrame: From baseline to 12 months
measure: Median healthcare resources use at 12 months
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Median of electronic prescription withdrawal at 12 months
timeFrame: At 12 months
measure: Median pre-bronchodilator forced expiratory volume in the first second (pre-bronchodilator FEV1) and zscore at 6 and 12 months
timeFrame: At 6 and 12 months
measure: Median AQLQ score at 6 and 12 months
timeFrame: At 6 and 12 months
measure: Median FeNO value at 6 and 12 months
timeFrame: At 6 and 12 months
measure: Median blood eosinophil count at 12 months
timeFrame: At 12 months
Other outcomes:
Locations:
city: San Javier
country: Spain
facility: Hospital Los Arcos del Mar Menor
state: Murcia
Study officials:
References: