REspiratory reHABilitation and PSYchiatric Comorbidities

NCT06229600 | Completed

• 1 other identifier: CET 2023-3.11/439.1
• Study Type: observational
• Target: 994
• Locations: 1 country
• Sites: 6

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.

Conditions

Respiratory Disease

Keywords

Chronic respiratory insufficiency; Cognitive impairment; Mental Health; COPD; Lung diseases

Outcome Measures

Primary Outcomes (1)

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

  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

  At one month

Secondary Outcomes (8)

• 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 frailty: BRASS

  At baseline and one month

• Response to rehabilitation on dyspnea symptoms: Medical Research Council (MRC)

  At baseline and one month

Study Arms (6)

Group A

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

Other: Standard rehabilitation

Group B

Patients on medication (psychotropic drugs) without a reported/reported specific psychiatric diagnosis in their clinical history.

Other: Standard rehabilitation

Group C

Patients without a history/reported psychiatric disorder and without specific psychopharmacological therapy.

Other: Standard rehabilitation

Group D

Patients with a history of diagnosed neurocognitive disorder.

Other: Standard rehabilitation

Group E

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.

Other: Standard rehabilitation

Group F

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.

Other: Standard rehabilitation

Interventions

Standard rehabilitation OTHER

Respiratory rehabilitation

Group A; Group B; Group C; Group D; Group E; Group F

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (6)

Istituti Clinici Scientifici Maugeri

Telese Terme, Benevento, Italy

Location

Istituti Clinici Scientifici Maugeri

Lumezzane, Brescia, 25065, Italy

Location

Istituti Clinici Scientifici Maugeri

Montescano, Pavia, Italy

Location

Istituti Clinici Scientifici Maugeri

Bari, Italy

Location

Istituti Clinici Scientifici Maugeri

Milan, Italy

Location

Istituti Clinici Scientifici Maugeri

Pavia, 27100, Italy

Location

Related Publications (8)

• 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.

  PMID: 36900872 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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.

  PMID: 19720809 BACKGROUND

• 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.

  PMID: 2760661 BACKGROUND

• 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.

  PMID: 27354778 BACKGROUND

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 1629535 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Respiration Disorders; Cognitive Dysfunction; Psychological Well-Being; Pulmonary Disease, Chronic Obstructive; Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Vitacca, MD

  Istituti Clinici Scientifici Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 29, 2024
• Study Start: January 2, 2024
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)