Chronic Obstructive Pulmonary DiseaseASPECTO-BPCONCT06509308
Illness Expectations in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Psychological Questionnaires
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Non-Italian speakers
- Psychiatric comorbidities
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Don Gnocchi Foundation
Milan, 20148
Eleonora Volpato, 3293782692, eleonora.volpato@unicatt.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Psychological Questionnaires
- Keywords
- Chronic Obstructive Pulmonary Disease, Clinical Psychology, Rehabilitation Psychology, Chronic Illness
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological QuestionnairesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From October 2023 to January 2025
Secondary outcomes (9)
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.
Measured: From October 2023 to January 2025
Body Mass Index
kg/m^2
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: From October 2023 to January 2025
Pharmacological Therapy
A list of the medications taken by the patient.
Measured: From October 2023 to January 2025
Comorbidities
A list of the major illness suffered from the patient.
Measured: From October 2023 to January 2025
Exacerbations and hospitalizations
frequency of exacerbations and hospitalizations over the past year
Measured: From October 2023 to January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start30 Oct 2023
- Primary completion30 Oct 2023
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Volpato, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509308
- Sponsor's protocol ID
- FDG 88-18
- Acronym
- ASPECTO-BPCO
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31703607Rennard 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.
PubMed 9552012Kaptein 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.
PubMed 18951252Evers 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.
PubMed 11777106Broadbent 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.
PubMed 16731240
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Expectations in Chronic Obstructive Pulmonary Disease (COPD) - Development and Validation of a New Tool
- ClinicalTrials.gov ID
- NCT06509308
- Acronym / sponsor ID
- ASPECTO-BPCO / FDG 88-18
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Clinical Psychology, Rehabilitation Psychology, Chronic Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Non-Italian speakers
- Psychiatric comorbidities
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological QuestionnairesPatients 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. | Other | – |
Primary outcome
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.
9 secondary outcomes
Socio-demographic variables
Time frame: From October 2023 to January 2025
Body Mass Index
Time frame: From October 2023 to January 2025
Medical data
Time frame: From October 2023 to January 2025
Brief Illness Perception Questionnaire
Time frame: From October 2023 to January 2025
Illness Cognition Questionnaire
Time frame: From October 2023 to January 2025
Chronic Obstructive Pulmonary Disease Assessment TEST
Time frame: From October 2023 to January 2025
Pharmacological Therapy
Time frame: From October 2023 to January 2025
Comorbidities
Time frame: From October 2023 to January 2025
Exacerbations and hospitalizations
Time frame: From October 2023 to January 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Results publication: PubMed 31703607Pagnini 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.
- Results publication: PubMed 9552012Rennard 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.
- Results publication: PubMed 18951252Kaptein 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.
- Results publication: PubMed 11777106Evers 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.
- Results publication: PubMed 16731240Broadbent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Volpato, PHD (3293782692, eleonora.volpato@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Obstructive Pulmonary Disease Expectations Questionnaire (time frame: From October 2023 to January 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06509308, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.