Clinical trial NCT06229600: REspiratory reHABilitation and PSYchiatric Comorbidities
Official title: Respiratory Rehabilitation and the Impact of Psychiatric Comorbidities
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Respiratory Disease
Keywords: Chronic respiratory insufficiency
Cognitive impairment
Mental Health
COPD
Lung diseases
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On admission (T0), clinical history, admission diagnosis, and current medication history will be collected for all patients admitted for respiratory rehabilitation. All patients will follow their tailored rehabilitation program according to the medical indication. At the time of discharge, they will be classified into six groups (A-F) according to the presence/absence of a psychiatric/cognitive diagnosis and/or pharmacological therapy.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of patients with or without comorbidities of psychiatric/neurocognitive disorders present on discharge from a respiratory rehabilitation program
timeFrame: At one month
Secondary outcomes:
measure: Gender difference
timeFrame: At one month
measure: Response to rehabilitation on disease impact: CAT
timeFrame: At baseline and one month
measure: Response to rehabilitation on motor disability: Barthel Index
timeFrame: At baseline and one month
measure: Response to rehabilitation on frailty: BRASS
timeFrame: At baseline and one month
measure: Response to rehabilitation on dyspnea symptoms: Medical Research Council (MRC)
timeFrame: At baseline and one month
measure: Response to rehabilitation on dyspnea symptoms: Barthel Dyspnoea Index (Bld)
timeFrame: At baseline and one month
measure: Response to rehabilitation on effort tolerance: 6-Minute Walking Test (6MWT)
timeFrame: At baseline and one month
measure: Prevalence of the anamnestic factors in all groups
timeFrame: At baseline
Other outcomes:
Locations:
city: Telese Terme
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Benevento
city: Lumezzane
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Brescia
city: Montescano
country: Italy
facility: Istituti Clinici Scientifici Maugeri
state: Pavia
city: Bari
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Milano
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
Study officials:
affiliation: Istituti Clinici Scientifici Maugeri
name: Michele Vitacca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Luca V, Femminella GD, Leonardini L, Patumi L, Palummeri E, Roba I, Aronni W, Toccoli S, Sforzin S, Denisi F, Basso AM, Ruatta M, Obbia P, Rizzo A, Borgioli M, Eccher C, Farina R, Conforti D, Mercurio L, Salvatore E, Gentile M, Bocchino M, Sanduzzi Zamparelli A, Viceconte G, Gentile I, Ruosi C, Ferrara N, Fabbrocini G, Colao A, Triassi M, Iaccarino G, Liotta G, Illario M. Digital Health Service for Identification of Frailty Risk Factors in Community-Dwelling Older Adults: The SUNFRAIL+ Study Protocol. Int J Environ Res Public Health. 2023 Feb 21;20(5):3861. doi: 10.3390/ijerph20053861.
citation: Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
citation: Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.
citation: Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
citation: Vitacca M, Paneroni M, Baiardi P, De Carolis V, Zampogna E, Belli S, Carone M, Spanevello A, Balbi B, Bertolotti G. Development of a Barthel Index based on dyspnea for patients with respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2016 Jun 7;11:1199-206. doi: 10.2147/COPD.S104376. eCollection 2016.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Blaylock A, Cason CL. Discharge planning predicting patients' needs. J Gerontol Nurs. 1992 Jul;18(7):5-10. doi: 10.3928/0098-9134-19920701-05.
citation: J. E. Cotes, D. J. Chinn, MRC questionnaire (MRCQ) on respiratory symptoms. Occupational Medicine 2007; 57 (5): 388. https://doi.org/10.1093/occmed/kqm051.