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Illness Expectations in COPD

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06509308
Acronym
ASPECTO-BPCO
Enrollment
200
Registered
2024-07-19
Start date
2023-10-30
Completion date
2025-01-31
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, Clinical Psychology, Rehabilitation Psychology, Chronic Illness

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.

Interventions

Patients will be asked to complete a series of questionnaires regarding disease expectations, cognitions, and representations of their health status. Additionally, sociodemographic data and clinical variables will be collected from medical records.

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic Obstructive Pulmonary Disease Expectations QuestionnaireFrom October 2023 to January 2025A 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.

Secondary

MeasureTime frameDescription
Body Mass IndexFrom October 2023 to January 2025kg/m\^2
Medical dataFrom October 2023 to January 2025parameters 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).
Brief Illness Perception QuestionnaireFrom October 2023 to January 2025The 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.
Illness Cognition QuestionnaireFrom October 2023 to January 2025The 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).
Socio-demographic variablesFrom October 2023 to January 2025Gender, 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.
Pharmacological TherapyFrom October 2023 to January 2025A list of the medications taken by the patient.
ComorbiditiesFrom October 2023 to January 2025A list of the major illness suffered from the patient.
Exacerbations and hospitalizationsFrom October 2023 to January 2025frequency of exacerbations and hospitalizations over the past year
Chronic Obstructive Pulmonary Disease Assessment TESTFrom October 2023 to January 2025The 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

Countries

Italy

Contacts

Primary ContactEleonora Volpato, PHD
eleonora.volpato@unicatt.it3293782692
Backup ContactEleonora Volpato
eleonora.volpato@unicatt.it3293782692

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026