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

NCT ID: NCT05642728

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-10-15

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.

Conditions

Asthma; Case Management; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Case management group

Group Type: EXPERIMENTAL

Case management follow-up program

Intervention Type: OTHER

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Case management follow-up program

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MurciaSalud

OTHER_GOV

Sponsor Role: lead

Responsible Party

Manuel Castilla Martinez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Los Arcos del Mar Menor

San Javier, Murcia, Spain

Countries

Spain

Other Identifiers

PERCASTHMA STUDY

Identifier Type: -

Identifier Source: org_study_id