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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Median ACT score at 6 and 12 months compared with control group and baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Signed informed consent form.
排除标准
- •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.
研究组 & 干预措施
Case management group
干预措施: Case management follow-up program (Other)
Control group
结局指标
主要结局
Median ACT score at 6 and 12 months compared with control group and baseline
时间窗: 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 healthcare resources use at 12 months
时间窗: 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
Median of total and severe exacerbations at 12 months
时间窗: 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
次要结局
- 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)
研究者
Manuel Castilla Martinez
Principal Investigator
MurciaSalud