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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma, Case Management, Telemedicine

Intervention / Treatment
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* Other: Case management follow-up program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Previous diagnosis of bronchial asthma according to GEMA 5.2 criteria. Follow-up in an asthma unit for at least 6 months and who do not present relevant uncontrolled comorbidities. Classified as moderate or severe asthma according to therapeutic step at the beginning of the study, as defined by GEMA 5.1. Aptitude for handling the technologies used. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case management group<br> | Other: Case management follow-up program<br>* The case manager will monitor asthma control (asthma control test, ACT) and adherence to treatment with questionnaires (inhaler adherence test, TAI) and electronic prescription withdrawal (e-prescription). The case manager will make decisions based on these results and according to pre-designed medical instructions. In addition, the patient will be able to contact the case manager for advice during periods of worsening symptoms. The patient will contact the case manager via a mobile app with messaging and video call option, as well as a contact phone number and email for consultations.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized asthma exacerbation rate | Accumulated asthma exacerbations during follow-up period compared with control group and baseline | From baseline to 12 months | 
| Annualized hospital admissions, emergency room visits, and unscheduled medical visits for asthma exacerbation rate | Hospital admissions, emergency room visits, and unscheduled medical visits for asthma exacerbation accumulated at the end of the follow-up period compared with control group and baseline | From baseline to 12 months | 
| Average ACT score at 6 and 12 months | ACT is a validated, self-administered questionnaire to assess asthma control in the last 4 weeks. Possible scores range from 5 (worst possible control) to 25 (best possible control). Scores equal to or greater than 20 suggest good asthma control. Average ACT score at 6 and 12 months compared with control group and baseline | At 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of low adherents at 12 months | Low adherence will be considered as electronic prescription withdrawal of less than 70% and/or a TAI score of 45 or lower. Percentage of low adherents at 12 months compared with control group and baseline | At 12 months | 
| Mean change from baseline in pre-bronchodilator forced expiratory volume in the first second (pre-bronchodilator FEV1) and zscore at 6 and 12 months | Lung function was measured according to the SEPAR guidelines. Zscore is a tool to express results of spirometry that facilitates interpretation and comparison between patients with different characteristics. The Z-score indicates how many standard deviations a measured value is from predicted. Mean change from baseline in pre-bronchodilator forced expiratory volume in the first second (pre-bronchodilator FEV1) and zscore at 6 and 12 months compared with control group and baseline | At 6 and 12 months | 
| Average AQLQ score at 6 and 12 months | Asthma Quality of Life Questionnaire (AQLQ) is a validated, self-administered questionnaire to assess quality of life related to asthma. Possible scores range from 1 (worst possible quality of life) to 7 (best possible). The minimum clinically significant change is 0.5 points. Average AQLQ score at 6 and 12 months compared with control group and baseline. | At 6 and 12 months | 
| Mean FeNO value at 6 and 12 months | Exhaled nitric oxide (FeNO) will be measured using NioxVero electrochemical analyser according to standard use technique. FeNO is measured in ppb. Mean FeNO value at 6 and 12 months compared with control group and baseline. | At 6 and 12 months | 
| Mean blood eosinophil count at 12 months | Mean blood eosinophil count at 12 months compared with control group and baseline. | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exacerbations, asthma, case manager, telemedicine