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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 1
- 主要终点
- Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)
研究概览
简要总结
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.
详细描述
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:
- 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).
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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:
- •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
结局指标
主要结局
Sexual health acording to The PROMIS Sex FS BF (vers. 2.0)
时间窗: Day 1
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.).
次要结局
- COPD-impact on health according to CAT(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)
- Well-being according to EQ-5D-5L Health related quality of life according to the EQ-5D-5L(Day 1)
- Loneliness according to The UCLA Loneliness Scale(Day 1)