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Completed

NCT Number: 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

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.

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Key information

Conditions

Asthma Bronchial Diseases Case Management Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Los Arcos del Mar Menor

San Javier, Murcia, 30739, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

  2. Median of total and severe exacerbations at 12 months

    Time frame: From baseline to 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

  3. Median healthcare resources use at 12 months

    Time frame: From baseline to 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

Secondary outcomes

  1. Median of electronic prescription withdrawal at 12 months

    Time frame: At 12 months

    To assess adherence, the percentage of withdrawal of inhaled glucocorticoid e-prescriptions will be measured.

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

    Time frame: 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. Median 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

  3. Median AQLQ score at 6 and 12 months

    Time frame: 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. Median AQLQ score at 6 and 12 months compared with control group and baseline.

  4. Median FeNO value at 6 and 12 months

    Time frame: 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. Median FeNO value at 6 and 12 months compared with control group and baseline.

  5. Median blood eosinophil count at 12 months

    Time frame: At 12 months

    Median blood eosinophil count at 12 months compared with control group and baseline.

Sponsors and collaborators

Lead sponsor

MurciaSalud

Other Gov

Registry information

Official study 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.

Acronym: PERCASTHMA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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