Chronic DiseaseNCT05696730
Holistic Wellbeing in COPD: Communication About Sexuality (COSY)
A study testing Communication intervention about sexuality in people with COPD in people with Chronic Disease and Lung Diseases, Obstructive, run by University of Zurich at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
- What is being tested?
- Communication intervention about sexuality in people with COPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Mar 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Zurich / Epidemiology, Biostatistics and Prevention Institute
Zurich, 8001
About this study
Official title: Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
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).
Read the 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.
- Being tested
- Communication intervention about sexuality in people with COPD
- Keywords
- Quality of life, COPD, Intimacy and sexuality, Communication intervention, Physical activity, Randomized controlled trial
- Medical subject headings
- Chronic Disease, Lung Diseases, Obstructive, Respiration Disorders, Pulmonary Disease, Chronic Obstructive, Sexuality, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication intervention about sexuality in people with COPDOther
COSY is a communication intervention which consists of one face to face counselling (75 min) and two 30-min telephone call counselling.
Patients assigned to the intervention group will get the COSY communication intervention with a special focus on the positive impact of sexuality on wellbeing plus specific motivation for physical activity. Together with the patient, a personalized re-enforcement instrument, the COSY-Compass, is elaborated to set individual goals and motivation for physical activity over the whole intervention period (3 months).
Participants will learn to understand the positive effect of regular physical activity on physical, mental, and cognitive wellbeing and a more fulfilling sex life as well as get inspiration about the spectrum and possible expressions and manifestations of caring and intimacy with oneself.
| Study group | Role | What they receive |
|---|---|---|
| Communication intervention about sexuality in people with COPD | Experimental | 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. Receives: Other: Communication intervention about sexuality in people with COPD |
| 30 minutes counselling and intervention material per request after the RCT | No intervention | Usual care. Participants will have the possibility to receive a brief version of the intervention on request (30 minutes counselling and intervention material) at the end of the 3-months follow-up assessment visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in old age (CASP-12)
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)
Measured: Change from baseline to 3 months
Secondary outcomes (7)
Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty)
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)
Measured: Change from baseline to 3 months, measured during 1 week
Functional exercise capacity (1-min Sit-to-Stand [STS] test)
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
Measured: Change from baseline to 3 months
COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales)
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
Measured: Change from baseline to 3 months
COPD-specific health status / Symptoms (COPD Assessment Test; CAT)
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)
Measured: Change from baseline to 3 months
Health status (Feeling Thermometer; FT)
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)
Measured: Change from baseline to 3 months
Exacerbations of COPD (event based, patient reported)
The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Measured: At 3-months follow-up assessment visit
Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)
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
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start21 Mar 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the control or intervention group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anja Frei, University of Zurich
- Investigators
- Anja Frei, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696730
- Sponsor's protocol ID
- COSY
- Status last verified
- Nov 2024
- First submitted
- 13 Jan 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dalla Lana K, Frei A, Radtke T, Braun J, Puhan MA, Steurer-Stey C. Communication About Sexuality (COSY) Encourages Physical Activity in COPD: A Randomised Trial. Int J Chron Obstruct Pulmon Dis. 2025 Oct 30;20:3535-3544. doi: 10.2147/COPD.S539514. eCollection 2025.
PubMed 41189719
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05696730
- Acronym / sponsor ID
- COSY
- Keywords
- Quality of life, COPD, Intimacy and sexuality, Communication intervention, Physical activity, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the control or intervention group.
| Arm | Type | Receives |
|---|---|---|
| Communication intervention about sexuality in people with COPD | Experimental | Other: Communication intervention about sexuality in people with COPDCommunication 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. |
| 30 minutes counselling and intervention material per request after the RCT | No intervention | –Usual care. Participants will have the possibility to receive a brief version of the intervention on request (30 minutes counselling and intervention material) at the end of the 3-months follow-up assessment visit. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication intervention about sexuality in people with COPDCOSY is a communication intervention which consists of one face to face counselling (75 min) and two 30-min telephone call counselling. Patients assigned to the intervention group will get the COSY communication intervention with a special focus on the positive impact of sexuality on wellbeing plus specific motivation for physical activity. Together with the patient, a personalized re-enforcement instrument, the COSY-Compass, is elaborated to set individual goals and motivation for physical activity over the whole intervention period (3 months). Participants will learn to understand the positive effect of regular physical activity on physical, mental, and cognitive wellbeing and a more fulfilling sex life as well as get inspiration about the spectrum and possible expressions and manifestations of caring and intimacy with oneself. | Other | Communication intervention about sexuality in people with COPD |
Primary outcome
Quality of life in old age (CASP-12)
Time frame: 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)
7 secondary outcomes
Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty)
Time frame: Change from baseline to 3 months, measured during 1 week
Functional exercise capacity (1-min Sit-to-Stand [STS] test)
Time frame: Change from baseline to 3 months
COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales)
Time frame: Change from baseline to 3 months
COPD-specific health status / Symptoms (COPD Assessment Test; CAT)
Time frame: Change from baseline to 3 months
Health status (Feeling Thermometer; FT)
Time frame: Change from baseline to 3 months
Exacerbations of COPD (event based, patient reported)
Time frame: At 3-months follow-up assessment visit
Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)
Time frame: Change from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 41189719Dalla Lana K, Frei A, Radtke T, Braun J, Puhan MA, Steurer-Stey C. Communication About Sexuality (COSY) Encourages Physical Activity in COPD: A Randomised Trial. Int J Chron Obstruct Pulmon Dis. 2025 Oct 30;20:3535-3544. doi: 10.2147/COPD.S539514. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anja Frei, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication intervention about sexuality in people with COPD in people with Chronic Disease and Lung Diseases, Obstructive, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in old age (CASP-12) (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.