Impact of COPD on Sexual Health, Loneliness, and Well-being

NCT ID: NCT06240078

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 521 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-09-19

Brief Summary

Summary Person-centered care is a hot topic within healthcare, yet communication about patients' sexual health and intimacy issues remain too hot to handle within healthcare. Research indicates that sexual dysfunction and impaired sexual health are frequent among individuals with chronic obstructive pulmonary disease (COPD). Despite patients expecting healthcare professionals to address intimacy issues; these issues are often neglected, since the topic is a taboo.

This study aims to address a gap in observational research by investigating the physical, psychological and social aspects of sexual health in both men and women with and without COPD. The primary hypothesis of this survey-based cross-sectional study is that COPD negatively impacts sexual health, leading to increased loneliness, relationship dissatisfaction, anxiety and/or depression, along with decreased health-related quality of life and well-being in patients. The study seeks to identify associations between impaired sexual health and these factors.

By fostering a new understanding of these aspects, this study is essential to promote person-centered communication about sexual health, addressing the often overlooked needs and concerns of individuals with COPD. Ultimately, the study has the potential to improve sexual health and overall well-being among individuals with COPD, contributing to a more person-centered approach in COPD care.

Detailed Description

Objectives The primary objectives of this study are to assess whether impaired sexual health is more prevalent in individuals with COPD compared to those without COPD and to explore its impact on well-being and health-related quality of life. Additionally, the study aims to comprehend the impact of COPD on sexual health by investigating potential associations among selected physical, psychological, and social factors related to sexual health. This understanding is crucial for guiding future studies on identified associations.

The study will examine the following assumptions:

1. Impaired sexual health, characterized by a higher prevalence of sexual dysfunction, dissatisfaction, and distress, is more frequent in individuals with COPD than in a control group (individuals without COPD, matched by age, gender, and relationship status).

2. COPD has a comprehensive impact on both physical, psychological, and social aspects of sexual health. Impaired sexual health is associated with increased loneliness, relationship dissatisfaction, anxiety and/or depression, as well as decreased health-related quality of life and overall well-being.

Method and materials This study adopts a cross-sectional design, utilizing a patient-reported questionnaire to collect data. The participant pool will encompass individuals aged 40 years or older, including those with COPD and a control group without COPD. The control group will be matched to the COPD sample based on age, gender, and relationship status, enhancing the precision of the exploration of COPD-specific challenges. All participants will be invited to complete a public online questionnaire, with all participants providing electronic informed consent before survey completion.

To explore the impact of COPD on sexual health, including COPD-specific factors, and to assess the perceived effect on quality of life, the questionnaire incorporates various validated instruments. Each instrument will measure a specific aspects related to the physical, psychological, or social dimension of sexual health. Sexual dysfunction and sexual health will be assessed using The PROMIS Sexual Function and Satisfaction Measures (Brief Profile), while emotions and concerns related to sexuality will be identified through The Sexual Distress Scale. Relationship dissatisfaction will be assessed using The Couples Satisfaction Index, loneliness through the UCLA Loneliness Scale, and anxiety/depression via the Hospital Anxiety and Depression Scale. Well-being will be evaluated using the EQ-5D-5L. Individuals with COPD will provide additional insights into the impact of COPD on health through the COPD Assessment Test.

Based on a power calculation (two-sided; p<0.05; power=95%) (26), the study's exploratory approach, and the number of variables, a sample size of minimum 200 participants per group is deemed sufficient to identify associations.

Descriptive statistics, including means, standard deviations, and frequencies, will be employed to report the prevalence of sexual health and summarize data related to COPD-specific challenges. Correlation coefficients will be calculated, and multiple regression analyses will be conducted to identify associations between variables, adjusting for potential confounders. STATA will be used for data analysis. The study results will be reported in accordance with the STROBE guidelines (22).

Conditions

Pulmonary Disease, Chronic Obstructive; Sexual Health; Loneliness; Well-Being, Psychological

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

COPD group

COPD group: Participants with self-reported COPD (Group 1)

No interventions assigned to this group

Non-COPD group

Non-COPD group: Participants without self-reported COPD, but with other chronic diseases. A comparison group (Group 2)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

COPD Population

• Mild to very servere COPD
• ≥40 years old
• Living in Denmark
• Consent to participate the online survey

Control Group:

• Non-COPD, but wit another chronic/longtern disease
• ≥40 years old
• Living in Denmark
• Consent to participate the online survey

Exclusion Criteria

COPD Population:

• Unwilling to participate and complete the online survey
• Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers

Control Group:

• COPD
• Unwilling to participate and complete the online survey
• Inability to participate and answer the survey questions in Danish due to cognitive impairment, servere illness, or reading or language barriers

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region of Southern Denmark

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders L. Ottesen, D.M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Vejle Hospital, Lillebaelt Hospital

Locations

Vejle Hospital, part of Lillebaelt Hospital

Vejle, Region Syddanmark, Denmark

Countries

Denmark

Other Identifiers

COPD and sexual health

Identifier Type: -

Identifier Source: org_study_id