REspiratory reHABilitation and PSYchiatric Comorbidities (REHABPSY)

I

Istituti Clinici Scientifici Maugeri SpA

Status

Enrolling

Conditions

Respiratory Disease

Treatments

Other: Standard rehabilitation

Study type

Observational

Funder types

Other

Identifiers

NCT06229600
CET 2023-3.11/439.1

Details and patient eligibility

About

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.

Full description

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. Gender differences in reporting psychiatric and respiratory comorbidity have been previously observed: twice as many psychiatric disorders in women as in men, and with higher levels of anxiety and depression in women than in men. Pulmonary diseases are historically and etiologically related to smoking and unfavorable environmental exposures, two factors that are more present in less affluent social groups, where an increase in psychiatric diseases is known. People with psychiatric diseases and fewer contextual resources also arrive later to be diagnosed with COPD and/or lung cancer, thus leading to a more unfavorable course. Respiratory rehabilitation is for some respiratory diseases the standard of care among non-pharmacological therapies and should possibly lead to a return to a state of health identified as the person's 'well-being'. As recently published in a study conducted by the Italian Health Ministry, only 18% of Italians feel in a state of full well-being, understood as a state of complete physical, mental, and social well-being and not simply the absence of disease', indicating how complex it is to achieve this state, particularly for people with respiratory pathologies. In recent years, therefore, there has been growing scientific evidence that there is a close correlation between mental and physical health to achieve maximum well-being also understood as 'the ability to adapt and self-manage in the face of social, physical and emotional challenges. For some years now, and even more after the recent severe acute respiratory syndrome (SARS)-CoV-2 pandemic outbreak, more and more attention has been paid to psychological and psychiatric disorders, especially anxiety, depression, and substance abuse. Patients admitted to in-hospital respiratory rehabilitation often have complex comorbidities that affect recovery after an acute event. These studies suggest that psychiatric/neurodegenerative pathologies may therefore significantly impact the patient's condition by increasing the risk of developing pulmonary disease, slowing down diagnosis and treatment, and acting as a brake on the possibility of deriving maximum benefit from pharmacological and non-pharmacological treatments such as rehabilitation and the continuation of adequate chronic disease management at home. To our knowledge, there is no reliable quantification in Italy of the percentage of the presence of mental disorders (psychiatric/neurodegenerative) according to the DSM-5 classification in respiratory patients as well as the prevalence of mental disorders present among patients requiring in-hospital rehabilitation treatment. The study hypothesizes that these disorders are present among patients admitted to rehabilitation centers and that they may impact the final rehabilitation outcome for various reasons, including a reduced awareness of one's health condition, greater difficulty in therapeutic adherence, the ability to self-monitor, the reduction of risk factors and a reduced availability of resources. This also results in reduced effectiveness of the education provided. The presence of mental disorders also has a significant impact on family members and caregivers who should ultimately participate in the full implementation of the rehabilitation project. We consider as important to evaluate this aspect as well with this Italian-based survey. With this study we therefore intend to assess in our Institutes how many people arrive with a diagnosis and/or treatment for mental disorders, how many need attention, and how many are identified or suspected to be affected by a psychiatric/neurodegenerative disease during their stay, during routine assessments, collecting clinical history, treatment and comorbidities. Treating the patient as a clinical team with multiple approaches, it can be argued that clinically significant signs and symptoms of psychiatric/neurocognitive disorders are detected with adequate accuracy even in the absence of formal psychiatric assessment, which would make the study unduly burdensome in the setting of interest and could undermine patient acceptance. All adult patients consecutively admitted for a course of Respiratory Rehabilitation - in 12 months - to the Units of Respiratory Rehabilitation belonging to the Department of Pneumology of the Maugeri Scientific Clinical Institutes will be studied. On admission (T0), anthropometric, clinical history (comorbidities measured with CIRS scale, presence of chronic respiratory failure (CRF), oxygen (O2) use, smoking history with number of packs/year, drug therapy, number of respiratory flare-ups per year, number of respiratory hospitalizations per year, days since respiratory index event, admission diagnosis, and current medication history will be collected. Moreover: Frailty assessment: Sunfrail tool (ST) is a questionnaire for measuring frailty among older people. ST is a 9-item questionnaire consisting of nine questions selected from evidence-based tools already used in health services in the European Union and the USA to identify frailty in the bio (physical), psycho (cognitive and psychological), and social domains. The answer can be yes or no. Important is the percentage of yes, and important is frailty. Pulmonary function assessment of forced expiratory volume at one second (FEV1), forced vital capacity (FVC), and FEV1/FVC; if the patient is respiratory insufficient: saturation of oxygen (SatO2) in oxygen/air, oxygen desaturation index (ODI)/h, average night SatO2, and time under 90% oxygen saturation (T<90). Psychological/neuropsychological assessment by the Centre's psychologists only if specifically requested during the rehabilitation program by the relevant clinician. Sleep survey: Insomnia Severity Index. Designed as a brief screening tool for insomnia, the seven-item questionnaire Insomnia Severity Index (ISI) asks respondents to rate the nature and symptoms of their sleep problems using a Likert-type to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). At the time of discharge from rehabilitation, patients will be classified according to the group A-F definition.

Enrollment

2,100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

2,100 participants in 6 patient groups

Group A
Description:
Patients with an established diagnosis according to the DSM-5 classification (DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS - FIFTH EDITION, 2014) and possible drug therapy (24). Schizophrenia spectrum disorders and other psychotic disorders Bipolar disorder and related disorders Depressive disorders Anxiety disorders Obsessive-compulsive disorder and related disorders Disorders related to traumatic and stressful events Dissociative disorders Somatic symptoms and related disorders Nutrition and eating disorders Evacuation disorders Sleep-wake disorders Sexual dysfunctions Gender dysphoria Disruptive behaviour, impulse control and conduct disorder Substance-related and addiction disorders Personality disorders Paraphilia disorders Autism spectrum disorders ADHD
Treatment:
Other: Standard rehabilitation
Group B
Description:
Patients on medication (psychotropic drugs) without a reported/reported specific psychiatric diagnosis in their clinical history.
Treatment:
Other: Standard rehabilitation
Group C
Description:
Patients without a history/reported psychiatric disorder and without specific psychopharmacological therapy.
Treatment:
Other: Standard rehabilitation
Group D
Description:
Patients with a history of diagnosed neurocognitive disorder.
Treatment:
Other: Standard rehabilitation
Group E
Description:
Patients in the practice without a history/report of psychiatric disorders and without specific psychopharmacological treatment on admission who are diagnosed during admission. This is a subgroup of the C group.
Treatment:
Other: Standard rehabilitation
Group F
Description:
Patients in the practice without a history/report of psychiatric disorders and without specific psychopharmacological therapy on admission who are diagnosed during admission for suspected psychiatric/neurocognitive pathology and are discharged with indications for further investigation at the territorial services. This is a subgroup of the C group.
Treatment:
Other: Standard rehabilitation

Trial contacts and locations

6

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Central trial contact

Gundi Steinhilber, MD; Michele Vitacca, MD

Data sourced from clinicaltrials.gov

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