Clinical trial NCT05696730: Holistic Wellbeing in COPD: Communication About Sexuality (COSY)
Official title: Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Lung Diseases, Obstructive
Respiratory Disease
Keywords: Quality of life
COPD
Intimacy and sexuality
Communication intervention
Physical activity
Randomized controlled trial
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the control or intervention group.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quality of life in old age (CASP-12)
timeFrame: Change from baseline to 3 months
Secondary outcomes:
measure: Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty)
timeFrame: Change from baseline to 3 months, measured during 1 week
measure: Functional exercise capacity (1-min Sit-to-Stand [STS] test)
timeFrame: Change from baseline to 3 months
measure: COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales)
timeFrame: Change from baseline to 3 months
measure: COPD-specific health status / Symptoms (COPD Assessment Test; CAT)
timeFrame: Change from baseline to 3 months
measure: Health status (Feeling Thermometer; FT)
timeFrame: Change from baseline to 3 months
measure: Exacerbations of COPD (event based, patient reported)
timeFrame: At 3-months follow-up assessment visit
measure: Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)
timeFrame: Change from baseline to 3 months
Other outcomes:
measure: Experience and feedback with the counselling program of the health professionals
timeFrame: At 3-months follow-up assessment visit
measure: Experience and satisfaction with the counselling program of the participants
timeFrame: At 3-months follow-up assessment visit
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich / Epidemiology, Biostatistics and Prevention Institute
Study officials:
affiliation: University of Zurich
name: Anja Frei, PhD
role: PRINCIPAL_INVESTIGATOR
References: