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

NCT05642728 | Completed

• 1 other identifier: PERCASTHMA STUDY
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

asthma; case manager; telemedicine; exacerbations

Outcome Measures

Primary Outcomes (3)

• Median ACT score at 6 and 12 months compared with control group and baseline

  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. Median ACT score at 6 and 12 months compared with control group and baseline

  At 6 and 12 months

• Median of total and severe exacerbations at 12 months

  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

• Median healthcare resources use at 12 months

  Healthcare resource use was defined as the addition of the number of unscheduled medical visits in primary care, emergency department care and hospitalisations. Median use of health resources at 12 months compared with control group and baseline

  From baseline to 12 months

Secondary Outcomes (5)

• Median of electronic prescription withdrawal at 12 months

  At 12 months

• Median pre-bronchodilator forced expiratory volume in the first second (pre-bronchodilator FEV1) and zscore at 6 and 12 months

  At 6 and 12 months

• Median AQLQ score at 6 and 12 months

  At 6 and 12 months

• Median FeNO value at 6 and 12 months

  At 6 and 12 months

• Median blood eosinophil count at 12 months

  At 12 months

Study Arms (2)

Case management group

EXPERIMENTAL

Other: Case management follow-up program

Control group

NO INTERVENTION

Interventions

Case management follow-up program 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.

Case management group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MurciaSalud: lead

Study Sites (1)

Hospital Los Arcos del Mar Menor

San Javier, Murcia, 30739, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: October 15, 2022
• Primary Completion: May 15, 2024
• Study Completion: October 15, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

ES (1)