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

NCT06240078 | Completed

• 1 other identifier: COPD and sexual health
• Study Type: observational
• Target: 521
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

COPD; sexual distress; sexual health; anxiety; depression; loneliness; chronic; associations

Outcome Measures

Primary Outcomes (1)

• Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)

  The PROMIS® Sexual Function and Satisfaction Measures, version 2.0. Brief Profile (PROMIS SexFS BF v2.0) universally assesses Sexual Function and Satisfaction. A general screener item inquires about sexual activity in the past 30 days. Respondents who have been sexually active answer items covering various domain, e.g. Interest in Sexual Activity, Satisfaction with Sex Life, Orgasm Ability and Pleasure, Erectile Function, Vaginal Discomfort and Lubrication. Most items are gender-nonspecific. Higher scores indicate greater Interest, Satisfaction, Orgasm ability, etc. Each domain's summed raw score is converted to T-scores, standardized to the U.S. general population (mean 50, SD 10). A clinically meaningful cutoff is five points below the population mean. (Weinfurt KP et al. J Sex Med. 2015;12:1961-1974.).

  Day 1

Secondary Outcomes (6)

• Loneliness according to The UCLA Loneliness Scale

  Day 1

• Well-being according to EQ-5D-5L Health related quality of life according to the EQ-5D-5L

  Day 1

• Anxiety and depression according to HADS

  Day 1

• Relationship satisfaction according to The Couples Satisfaction Index

  Day 1

• Sexual distress according to The Sexual Distress Scale

  Day 1

Study Arms (2)

COPD group

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

Non-COPD group

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

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, controled by age, sex, and relationship status, will serve as a reference group. This comparison 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vejle Hospital: lead
• Region of Southern Denmark: collaborator

Study Sites (1)

Vejle Hospital, part of Lillebaelt Hospital

Vejle, Region Syddanmark, 7100, Denmark

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Psychological Well-Being; Anxiety Disorders; Depression; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Anders L. Ottesen, D.M.Sc.

  Vejle Hospital, Lillebaelt Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: February 20, 2024
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

DK (1)