AsthmaPERCASTHMANCT05642728
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
A study testing Case management follow-up program in people with Asthma and Case Management, run by MurciaSalud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Case Management, Telemedicine
- What is being tested?
- Case management follow-up program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2022to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read more
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
- Being tested
- Case management follow-up program
- Keywords
- asthma, case manager, telemedicine, exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case management follow-up programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Case management group | Experimental | Not described Receives: Other: Case management follow-up program |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From baseline to 12 months
Secondary outcomes (5)
Median of electronic prescription withdrawal at 12 months
To assess adherence, the percentage of withdrawal of inhaled glucocorticoid e-prescriptions will be measured.
Measured: At 12 months
Median 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. 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
Measured: At 6 and 12 months
Median 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. Median AQLQ score at 6 and 12 months compared with control group and baseline.
Measured: At 6 and 12 months
Median 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. Median FeNO value at 6 and 12 months compared with control group and baseline.
Measured: At 6 and 12 months
Median blood eosinophil count at 12 months
Median blood eosinophil count at 12 months compared with control group and baseline.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start15 Oct 2022
- Primary completion15 May 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MurciaSalud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Manuel Castilla Martinez, MurciaSalud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642728
- Sponsor's protocol ID
- PERCASTHMA STUDY
- Acronym
- PERCASTHMA
- Status last verified
- Nov 2024
- First submitted
- 30 Nov 2022
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05642728
- Acronym / sponsor ID
- PERCASTHMA / PERCASTHMA STUDY
- Conditions
- Asthma, Case Management, Telemedicine
- Keywords
- asthma, case manager, telemedicine, exacerbations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MurciaSaludOther government
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case management group | Experimental | Other: Case management follow-up program |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Previous diagnosis of bronchial asthma according to GEMA 5.4 criteria.
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case management follow-up programThe 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. | Other | Case management group |
Primary outcome
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
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
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
5 secondary outcomes
Median of electronic prescription withdrawal at 12 months
Time frame: At 12 months
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
Median AQLQ score at 6 and 12 months
Time frame: At 6 and 12 months
Median FeNO value at 6 and 12 months
Time frame: At 6 and 12 months
Median blood eosinophil count at 12 months
Time frame: At 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management follow-up program in people with Asthma and Case Management, run by MurciaSalud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median ACT score at 6 and 12 months compared with control group and baseline (time frame: At 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.