Holistic well-being in COPD includes communication about sexuality: the COSY study (COmmunication about SexualitY)
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Zürich
(BASEC)
Sponsor
Epidemiology, Biostatistics and Prevention Institute, University of Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Claudia Steurer-Stey
+41 44 634 43 60
claudia.steurer-stey@clutteruzh.chUniversität Zürich und mediX Gruppenpraxis Zürich
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
22.12.2022
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Holistic wellbeing in COPD: The communication about Sexuality (COSY) randomized controlled trial (BASEC)
Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie
Zusammenfassung der Ergebnisse
information-teilnehmende.pdfLink zu den Ergebnissen im Primärregister
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