Clinical trial NCT06240078: Impact of COPD on Sexual Health, Loneliness, and Well-being
Official title: Impact of Chronic Obstructive Pulmonary Disease (COPD) on Sexual Health, Loneliness, and Well-being: A Cross-sectional Study of Prevalence and Associated Variables in Individuals With and Without COPD
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pulmonary Disease, Chronic Obstructive
Sexual Health
Loneliness
Well-Being, Psychological
Keywords: COPD
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
First posted: 2024-02-02
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include individuals aged 40 years or older, encompassing both men and women. The primary focus will be on individuals diagnosed with Chronic Obstructive Pulmonary Disease (COPD), recruited from relevant websites and social media, primarily through the Danish Lung Association platform (www.lungeforeningen.dk). Additionally, a COPD-free control group, carefully matched in age, gender, and relationship status, will serve as a reference group. This control group plays a crucial role in identifying COPD-specific challenges. Most non-COPD individuals will be recruited via the 'Aeldresagen.dk' platform. All participants must be capable and willing to complete a public online questionnaire. The study's diverse demographic ensures a comprehensive exploration of COPD-related factors.

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).

Eligibility criteria: Participant inclusion is based upon the reported information provided by the study participants:

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
* ≥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
* Spouse or partner with 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

Primary outcomes:
measure: Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)
timeFrame: Day 1
Secondary outcomes:
measure: Loneliness according to The UCLA Loneliness Scale
timeFrame: Day 1
measure: Well-being according to EQ-5D-5L Health related quality of life according to the EQ-5D-5L
timeFrame: Day 1
measure: Anxiety and depression according to HADS
timeFrame: Day 1
measure: Relationship satisfaction according to The Couples Satisfaction Index
timeFrame: Day 1
measure: Sexual distress according to The Sexual Distress Scale
timeFrame: Day 1
measure: COPD-impact on health according to CAT
timeFrame: Day 1
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital, part of Lillebaelt Hospital
state: Region Of Southern Denmark
Study officials:
affiliation: Vejle Hospital, Lillebaelt Hospital
name: Anders L. Ottesen, D.M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: