Holistic well-being in COPD includes communication about sexuality: the COSY study (COmmunication about SexualitY)
Summary description of the study
Human sexuality is a universal component of life and a crucial factor for quality of life. Sexuality problems are common among older and chronically ill individuals, such as those affected by COPD, and impact quality of life. A comprehensive assessment of quality of life that does not consider sexuality is therefore incomplete. We have developed a COPD-specific communication tool called COSY (COmmunication about SexualitY in COPD) to overcome these communication barriers and help appropriately and respectfully address sexual activity. The aim of this project is to investigate the effectiveness of the COSY communication intervention on quality of life and the maintenance of regular physical activity in people with COPD over a period of three months. We plan to include 160 individuals affected by COPD in the study and invite them to two study visits at the University of Zurich for data collection over a period of three months. Data collection will be conducted using standardized questionnaires, a short physical performance test, and wearing a motion sensor for nine days. After the first study visit, we will randomly assign participants either to the intervention group or to the control group (chance: 50% to 50%). Participants in the intervention group will receive the COSY communication intervention and will be invited to three additional conversation appointments: a personal conversation at the University of Zurich (approximately 75 minutes) and two telephone conversations (approximately 30 minutes each). The intervention will be conducted by experienced professionals with expertise in COPD disease management and coaching. Participants in the control group will receive no intervention and will only participate in data collection. At the end of the research project, they will have the opportunity to receive a shortened intervention.
(BASEC)
Intervention under investigation
Participants in the intervention group will be invited to three individual conversations with an experienced healthcare professional in the field of lung diseases during the first four weeks of the intervention.
The aim of the first personal COSY conversation (duration approximately 75 minutes) is to appropriately and respectfully address the topic of sexuality and intimacy in relation to COPD. Assessing confidence, motivational factors, and barriers to maintaining physical activity is part of this conversation. What a fulfilling intimate and sexual life means varies greatly from person to person. The COSY conversation guide takes this central aspect into account and shows the affected individuals, among other things, a selection of ideas and possible needs through imagery. The aspect that some participants do not live in a partnership is always considered. If restrictions in the desired intimate life are due to the lung disease, helpful and established approaches will be discussed and presented in the form of concrete measures. The individually desired goal, the concrete measures, supportive elements, and a plan B when difficulties arise will be collaboratively developed and documented in a personal COSY motivation document (COSY-Kompass). A central approach in the conversation will be the motivation to maintain regular physical activity. The desire for a fulfilling or more fulfilling intimate and sexual life may serve as an additional motivator for regular exercise. Participants will be asked to regularly use and fill out the collaboratively developed COSY-Kompass throughout the three-month study period. This document is intended to support them at home and continually remind them why they should engage in regular physical activity and what personally motivates them to become and remain physically fit.
One and three weeks later, telephone conversations will take place (approximately 30 minutes each). Using the COSY-Kompass, the past days will be reflected upon together and possible adjustments will be discussed. Assessing your confidence, motivational factors, and barriers to maintaining your physical activity is part of this conversation.
(BASEC)
Disease under investigation
Individuals with chronic obstructive pulmonary disease (COPD)
(BASEC)
- Diagnosis of chronic obstructive pulmonary disease (COPD) - Age: at least 60 years old - Sufficient knowledge of the German language to understand the study materials (BASEC)
Exclusion criteria
- Unstable COPD at the time of study inclusion (worsening of COPD within the last 4 weeks that required a change in therapy; increase in inhalation, use of cortisone tablets and/or antibiotic administration) - Other unstable illness at the time of study inclusion (unstable heart or cardiovascular disease) - Diagnosis of severe depression (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Epidemiology, Biostatistics and Prevention Institute, University of Zurich
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Claudia Steurer-Stey
+41 44 634 43 60
claudia.steurer-stey@clutteruzh.chUniversität Zürich und mediX Gruppenpraxis Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
22.12.2022
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Holistic wellbeing in COPD: The communication about Sexuality (COSY) randomized controlled trial (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
information-teilnehmende.pdfLink to the results in the primary register
not available