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NCT Number: NCT06509308

Illness Expectations in COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Don Gnocchi Foundation

Milan, 20148, Italy

Location status: Recruiting

Location contact

Eleonora Volpato

CONTACT

[email protected]

3293782692

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological questionnaires

Other

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.

Primary outcomes

  1. Chronic Obstructive Pulmonary Disease Expectations Questionnaire

    Time frame: From October 2023 to January 2025

    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.

Secondary outcomes

  1. Socio-demographic variables

    Time frame: From October 2023 to January 2025

    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.

  2. Body Mass Index

    Time frame: From October 2023 to January 2025

    kg/m^2

  3. Medical data

    Time frame: From October 2023 to January 2025

    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).

  4. Brief Illness Perception Questionnaire

    Time frame: From October 2023 to January 2025

    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.

  5. Illness Cognition Questionnaire

    Time frame: From October 2023 to January 2025

    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).

  6. Chronic Obstructive Pulmonary Disease Assessment TEST

    Time frame: From October 2023 to January 2025

    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

  7. Pharmacological Therapy

    Time frame: From October 2023 to January 2025

    A list of the medications taken by the patient.

  8. Comorbidities

    Time frame: From October 2023 to January 2025

    A list of the major illness suffered from the patient.

  9. Exacerbations and hospitalizations

    Time frame: From October 2023 to January 2025

    frequency of exacerbations and hospitalizations over the past year

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonora Volpato

CONTACT

[email protected]

3293782692

Eleonora Volpato, PHD

CONTACT

[email protected]

3293782692

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: ASPECTO-BPCO

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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