Clinical trial NCT06509308: Illness Expectations in COPD
Official title: The Role of Expectations in Chronic Obstructive Pulmonary Disease (COPD) - Development and Validation of a New Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Clinical Psychology
Rehabilitation Psychology
Chronic Illness
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 200
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: The patients involved in the study are from the cardio-respiratory rehabilitation department of the Don Gnocchi Foundation in Milan. They have a confirmed diagnosis of COPD, with the severity level specified according to guidelines (thus, patients with mild, moderate, severe, or very severe COPD are included). Both male and female patients of any age are admitted, provided they are adults. Patients may have other respiratory and non-respiratory conditions, as long as they are documented. Individuals who do not understand the Italian language or who exhibit psychiatric comorbidities or cognitive impairment cannot be included.

Brief summary: This study investigates the impact of expectations on individuals with Chronic Obstructive Pulmonary Disease (COPD) and aims to develop and validate a novel tool to assess these expectations. By understanding the role of expectations, healthcare providers can better tailor interventions and support for COPD patients, ultimately improving their quality of life and treatment outcomes.

Detailed description: This research, carried out at the specialized cardiorespiratory rehabilitation unit of the Don Gnocchi Foundation in Milan, delves into the influence of expectations on individuals living with Chronic Obstructive Pulmonary Disease (COPD). The primary objective is to craft and validate a fresh assessment tool to gauge these expectations. Moreover, the questionnaire is reintroduced to patients after a month, during which additional data, as detailed in the corresponding section, are gathered.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD confirmed by spirometry
* Adults
* Italian speakers
* Ability to complete the required tests
* Informed consent from the patient to participate in the study

Exclusion Criteria:

* Non-Italian speakers
* Psychiatric comorbidities
* Cognitive impairment

Primary outcomes:
measure: Chronic Obstructive Pulmonary Disease Expectations Questionnaire
timeFrame: From October 2023 to January 2025
Secondary outcomes:
measure: Socio-demographic variables
timeFrame: From October 2023 to January 2025
measure: Body Mass Index
timeFrame: From October 2023 to January 2025
measure: Medical data
timeFrame: From October 2023 to January 2025
measure: Brief Illness Perception Questionnaire
timeFrame: From October 2023 to January 2025
measure: Illness Cognition Questionnaire
timeFrame: From October 2023 to January 2025
measure: Chronic Obstructive Pulmonary Disease Assessment TEST
timeFrame: From October 2023 to January 2025
measure: Pharmacological Therapy
timeFrame: From October 2023 to January 2025
measure: Comorbidities
timeFrame: From October 2023 to January 2025
measure: Exacerbations and hospitalizations
timeFrame: From October 2023 to January 2025
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Don Gnocchi Foundation
Study officials:
References:
citation: Pagnini F. The potential role of illness expectations in the progression of medical diseases. BMC Psychol. 2019 Nov 8;7(1):70. doi: 10.1186/s40359-019-0346-4.
citation: Rennard SI. COPD: overview of definitions, epidemiology, and factors influencing its development. Chest. 1998 Apr;113(4 Suppl):235S-241S. doi: 10.1378/chest.113.4_supplement.235s.
citation: Kaptein AA, Scharloo M, Fischer MJ, Snoei L, Cameron LD, Sont JK, Rabe KF, Weinman J. Illness perceptions and COPD: an emerging field for COPD patient management. J Asthma. 2008 Oct;45(8):625-9. doi: 10.1080/02770900802127048.
citation: Evers AW, Kraaimaat FW, van Lankveld W, Jongen PJ, Jacobs JW, Bijlsma JW. Beyond unfavorable thinking: the illness cognition questionnaire for chronic diseases. J Consult Clin Psychol. 2001 Dec;69(6):1026-36.
citation: Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.