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临床试验/NCT06229600
NCT06229600已完成不适用

Respiratory Rehabilitation and the Impact of Psychiatric Comorbidities

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 994 人开始时间: 2024年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
994
试验地点
1
主要终点
Frequency of patients with or without comorbidities of psychiatric/neurocognitive disorders present on discharge from a respiratory rehabilitation program

研究概览

简要总结

Patients with respiratory insufficiency, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, asthma, bronchiectasis, and, to a lesser extent, other pathologies that result in respiratory insufficiency and require rehabilitation are admitted to in-hospital Respiratory Rehabilitation. Several studies have assessed the impact of comorbidities in the most frequent respiratory diseases such as COPD, asthma, pulmonary fibrosis, and cystic fibrosis in terms of worsening mortality, morbidity, and disease progression.

However, to our knowledge, there is no reliable quantification in Italy of the percentage of the presence of mental disorders (psychiatric/neurodegenerative) according to the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 classification in respiratory patients as well as the prevalence of mental disorders present among patients requiring in-hospital rehabilitation programs.

The study hypothesizes that these disorders are present among patients admitted to rehabilitation centers and that they may impact the final rehabilitation outcome.

详细描述

Patients with respiratory insufficiency, COPD, pulmonary fibrosis, asthma, bronchiectasis, and, to a lesser extent, other pathologies that result in respiratory insufficiency and require rehabilitation are admitted to in-hospital Respiratory Rehabilitation. Several studies have assessed the impact of comorbidities in the most frequent respiratory diseases such as COPD, asthma, pulmonary fibrosis, and cystic fibrosis in terms of worsening mortality, morbidity, and disease progression.

Comorbidities have been studied and assessed by scales such as the COTE, the Charlson comorbidity index (CCI), and the Cumulative Illness Rating Scale (CIRS). These comorbidities assessed predominantly focus on metabolic and cardiovascular aspects and only a small number of studies considered psychiatric comorbidity, mainly depression.

In previous studies depression, anxiety and psychiatric disease were 8th, 14th, and 23rd in frequency as comorbidity.

Other, more evaluated comorbidities were high blood pressure (17%-64.7%), coronary artery disease (19.9%-47.8%), diabetes mellitus (10.2%-45%) osteoarthritis (18%-43.8%), psychiatric conditions (12.1%-33%) and asthma (14.7%-32.5%).

Among psychological/psychiatric/neurodegenerative comorbidities, anxiety, and depression have been more extensively studied, with worse rehabilitation outcomes, more symptoms (especially dyspnoea), less functional exercise capacity, and minor quality of life (QOL). Similarly, patients with COPD and obstructive sleep apnea syndrome (OSAS), as demonstrated in numerous studies, are more frequently affected by neurocognitive disorders.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older than 18 years of age, of either sex, eligible for admission to a Respiratory Rehabilitation Unit and who have signed the informed consent attesting to the patient's voluntary participation.

排除标准

  • Patients unable to read, with significant speech and hearing impairment,or refusing participation.

结局指标

主要结局

Frequency of patients with or without comorbidities of psychiatric/neurocognitive disorders present on discharge from a respiratory rehabilitation program

时间窗: At one month

To quantify the percentage of patients in the study with or without comorbidities of psychiatric/neurocognitive disorders present on discharge from a respiratory rehabilitation pathway as follows: 1. established psychiatric diagnosis and drug therapy 2. drug therapy (psychotropic drugs) without a specific psychiatric diagnosis reported/reported in the history 3. no history/reported psychiatric disorder and no specific psychopharmacological therapy 4. history of diagnosis of neurocognitive disorder 5. absence of history/report of psychiatric disorders and without specific psychopharmacological treatment in inpatients receiving a diagnosis during admission 6. absence of history/report of psychiatric disorders and without specific psychopharmacological therapy on admission who receive a diagnosis during admission for suspected psychiatric/neurocognitive pathology and are discharged with indications for further investigation at the territorial services

次要结局

  • Gender difference(At one month)
  • Response to rehabilitation on disease impact: CAT(At baseline and one month)
  • Response to rehabilitation on motor disability: Barthel Index(At baseline and one month)
  • Response to rehabilitation on dyspnea symptoms: Medical Research Council (MRC)(At baseline and one month)
  • Response to rehabilitation on frailty: BRASS(At baseline and one month)
  • Response to rehabilitation on dyspnea symptoms: Barthel Dyspnoea Index (Bld)(At baseline and one month)
  • Prevalence of the anamnestic factors in all groups(At baseline)
  • Response to rehabilitation on effort tolerance: 6-Minute Walking Test (6MWT)(At baseline and one month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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