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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: MurciaSalud · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2022-10-15
• Primary completion: 2024-05-15
• Completion: 2024-10-15
• First posted: 2022-12-08
• Last updated: 2024-11-26

Locations

1 site across 1 country: Spain