NCT06509308

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

Same day

First QC Date

April 6, 2024

Last Update Submit

July 13, 2024

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseClinical PsychologyRehabilitation PsychologyChronic Illness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Socio-demographic variables

    From October 2023 to January 2025

  • Body Mass Index

    From October 2023 to January 2025

  • Medical data

    From October 2023 to January 2025

  • Brief Illness Perception Questionnaire

    From October 2023 to January 2025

  • Illness Cognition Questionnaire

    From October 2023 to January 2025

  • +4 more secondary outcomes

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Non-Italian speakers
  • Psychiatric comorbidities
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Don Gnocchi Foundation

Milan, 20148, Italy

RECRUITING

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveChronic Disease

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eleonora Volpato, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 6, 2024

First Posted

July 19, 2024

Study Start

October 30, 2023

Primary Completion

October 30, 2023

Study Completion

January 31, 2025

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations