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Completed

NCT Number: NCT05696730

Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

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).

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Key information

Conditions

Chronic Disease Behavior Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Disease Respiratory Tract Diseases Sexual Behavior Sexuality

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich / Epidemiology, Biostatistics and Prevention Institute

Zurich, 8001, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention about sexuality in people with COPD

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

    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)

  2. Functional exercise capacity (1-min Sit-to-Stand [STS] test)

    Time frame: 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

  3. COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales)

    Time frame: 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

  4. COPD-specific health status / Symptoms (COPD Assessment Test; CAT)

    Time frame: 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)

  5. Health status (Feeling Thermometer; FT)

    Time frame: 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)

  6. Exacerbations of COPD (event based, patient reported)

    Time frame: 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

  7. Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)

    Time frame: 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

Other outcomes

  1. Experience and feedback with the counselling program of the health professionals

    Time frame: At 3-months follow-up assessment visit

    Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)

  2. Experience and satisfaction with the counselling program of the participants

    Time frame: At 3-months follow-up assessment visit

    Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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