Holistic Wellbeing in COPD: Communication About Sexuality (COSY)
- Conditions
- Lung Diseases, ObstructiveChronic DiseaseRespiratory Disease
- Interventions
- Other: Communication intervention about sexuality in people with COPD
- Registration Number
- NCT05696730
- Lead Sponsor
- University of Zurich
- Brief Summary
The aim of this study is to assess the effectiveness of a communication intervention about sexuality on quality of life and other outcomes like physical activity, exercise capacity and health status in people with chronic obstructive pulmonary disease (COPD).
- Detailed Description
Human sexuality is a universal part of living and associated with quality of life and mental and physical health benefits. Improved sexual relationships and sexual activity might also be an intrinsic motivator to stay physically active. However, problems with sexuality and loss of sexual drive are common in older and chronically ill people like persons with chronic obstructive pulmonary disease (COPD). In persons with COPD sexuality is rarely addressed during medical consultations and the topic is not sufficiently researched despite the fact that a thorough assessment of quality of life is incomplete without considering sexuality.
Based on this background, the investigators developed an instrument that supports healthcare professionals to start and shape communication about sexuality: COSY. The COSY intervention consists of four tools (communication leaflet for health care professionals, application guidance, pictorial representation of the spectrum of intimacy for health care professionals, patient information booklet) and aims to sensitize persons with COPD with the topic sexuality.
The aim of this study is to assess the effectiveness of the COSY communication intervention on quality of life and other outcomes like physical activity, exercise capacity and health status in people with COPD.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Age ≥60 years
- Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC)<70% predicted, FEV1<80 % predicted after bronchodilation corresponding to a Global initiative on Obstructive Lung Disease (GOLD) stage II-IV
- Knowledge of German language to understand study material and assessments and being able to give informed consent as documented by signature
- Unstable COPD at the time of recruitment, unstable cardiovascular comorbidities, severe depression, or predicted life expectancy of less than one year, as judged by the referring clinician or the intervention physician
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Communication intervention about sexuality in people with COPD Communication intervention about sexuality in people with COPD Communication intervention. Individual counselling to improve holistic well-being by addressing sexuality and to increase adherence for long-term physical activity given the correlation with sexual activity.
- Primary Outcome Measures
Name Time Method Quality of life in old age (CASP-12) Change from baseline to 3 months The CASP is a validated measure developed specifically to assess quality of life in old age by the total score of the CASP-12 (Control, Autonomy, Self-realization and Pleasure) german short-version of the CASP-19 scale; 12 questions; 4-point Likert-type-scale ranging from 1 (never) to 4 (often)
- Secondary Outcome Measures
Name Time Method Functional exercise capacity (1-min Sit-to-Stand [STS] test) Change from baseline to 3 months The 1-min STS test assesses the number of repetitions that the patient completes the full sit-to-stand movement from a standard chair (i.e. standing up from a chair and sitting down again) during one minute
COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales) Change from baseline to 3 months The CRQ is a validated tool to assess COPD-specific health-related quality of life with four domains: Dyspnea, fatigue, emotional function, mastery domain. The total CRQ contains 20 questions responded to on a 7-point Likert-type scale, ranging from 1 to 7 with lower scores indicating worse HRQoL
Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty) Change from baseline to 3 months, measured during 1 week The C-PPAC is a validated and reliable hybrid tool combining a short patient-reported outcome questionnaire and two activity monitor variables (assessed by the accelerometer ActiGraph®) to measure physical activity in COPD patients in the two domains amount and difficulty; 12 questions; 5-point Likert-type-scale (item scores 0-4, scale 0-100, higher socres indicating higher amonunt of/less difficulty with physical activity)
COPD-specific health status / Symptoms (COPD Assessment Test; CAT) Change from baseline to 3 months The CAT measures the impact of COPD on a person's health status, covering the most burdensome symptoms and limitations of COPD; 8 questions; 6-point Likert-type scale (item scores: 0-5, overall score 0-40 with higher score indicating poorer health status)
Health status (Feeling Thermometer; FT) Change from baseline to 3 months The FT is a visual analogue scale for overall health state ranging from 0 (worst health you can imagine) to 100 (best healthy you can imagine)
Exacerbations of COPD (event based, patient reported) At 3-months follow-up assessment visit The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS) Change from baseline to 3 months The HADS assesses symptoms of anxiety and depression and contains 14 questions responded to on a 4-point Likert-type scale ranging from 0 to 3 with higher scores indicating a higher symptom score
Trial Locations
- Locations (1)
University of Zurich / Epidemiology, Biostatistics and Prevention Institute
🇨🇭Zurich, Switzerland