Illness Expectations in COPD (ASPECTO-BPCO)

The Role of Expectations in Chronic Obstructive Pulmonary Disease (COPD) - Development and Validation of a New Tool

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Psychological Questionnaires

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Eleonora Volpato, PhD; Phone Number: 3293782692; Email: eleonora.volpato@unicatt.it
• Study Contact Backup: Name: Eleonora Volpato; Phone Number: 3293782692; Email: eleonora.volpato@unicatt.it

Study Locations

• Italy
  • Milan, Italy, 20148
    • Recruiting
    • Don Gnocchi Foundation
    • Contact: Eleonora Volpato; Phone Number: 3293782692; Email: eleonora.volpato@unicatt.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Obstructive Pulmonary Disease Expectations Questionnaire	A questionnaire composed of 27 items, designed by us, asking the patient to assess their disease expectations for the next 3 months. Each item is rated on a 7-point Likert scale, allowing for a nuanced evaluation of the patient's perceptions and expectations. Scores range from 27 to 189. A higher score indicates a worse illness perception. A questionnaire composed of 27 items, designed by us, asking the patient to assess their disease expectations for the next 3 months. Each item is rated on a 7-point Likert scale, allowing for a nuanced evaluation of the patient's perceptions and expectations. Scores range from 27 to 189. A higher score indicates a worse illness perception.	From October 2023 to January 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socio-demographic variables	Gender, age, smoking status, and number of cigarettes smoked per day. Additionally, factors such as family history of respiratory diseases, alcohol use (frequency), physical activity (frequency and type), level of education, marital status, onset of initial symptoms, and date of diagnosis will be considered.	From October 2023 to January 2025
Body Mass Index	kg/m^2	From October 2023 to January 2025
Medical data	parameters from respiratory function tests (particularly Forced Vital Capacity (FVC) and Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO), arterial blood gas analysis) will be recorded. These data will be extracted from the latest available medical report and therefore from the last pulmonary visit conducted as part of routine clinical practice (please note that medical visits paid for by this project are not included).	From October 2023 to January 2025
Brief Illness Perception Questionnaire	The BIPQ is self-report questionnaire consisting of 8 items, rated on a 10-point Likert scale, investigates perceptions of illness (representations of cause, consequence, identity, control, duration), and requires the patient to nominate 3 factors they believe triggered the illness. The total score is calculated by summing the scores of all items, with a possible range of 0-80. Higher scores indicate worse illness perception. <42 indicating low experienced threat, 42-49 indicating moderate experienced threat, and ≥50 indicating high experienced threat in patients with a recently acquired spinal cord injury.	From October 2023 to January 2025
Illness Cognition Questionnaire	The ICG is a 18-item questionnaire that contains three 6-item scales related to the factors helplessness, acceptance and perceived benefits, each with a scoring range of 6-24 Helplessness (items 1, 5, 7, 9, 12, 15), Acceptance (items 2, 3, 10, 13, 14, 17), and Perceived Benefits (items 4, 6, 8, 11, 16, 18).	From October 2023 to January 2025
Chronic Obstructive Pulmonary Disease Assessment TEST	The CAT is a self-report questionnaire consisting of 8 items, rated on a 6-point Likert scale, where patients are asked to rate COPD impact on their quality of life. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life. Scores <10 have a low impact, 10-20 medium, 21-30 high and >30 very high impact	From October 2023 to January 2025
Pharmacological Therapy	A list of the medications taken by the patient.	From October 2023 to January 2025
Comorbidities	A list of the major illness suffered from the patient.	From October 2023 to January 2025
Exacerbations and hospitalizations	frequency of exacerbations and hospitalizations over the past year	From October 2023 to January 2025

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: July 13, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 13, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Chronic Illness; Clinical Psychology; Rehabilitation Psychology
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: FDG 88-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No