Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696730
• Other study ID #: COSY
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: Claudia Steurer-Stey, PhD
• Phone: +41 44 635 39 39
• Email: claudia.steurer-stey[@]uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Other:
• Communication intervention about sexuality in people with COPD
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.

Locations

Country	Name	City	State
Switzerland	University of Zurich / Epidemiology, Biostatistics and Prevention Institute	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Experience and feedback with the counselling program of the health professionals	Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)	At 3-months follow-up assessment visit
Other	Experience and satisfaction with the counselling program of the participants	Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)	At 3-months follow-up assessment visit
Primary	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)	Change from baseline to 3 months
Secondary	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)	Change from baseline to 3 months, measured during 1 week
Secondary	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	Change from baseline to 3 months
Secondary	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	Change from baseline to 3 months
Secondary	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)	Change from baseline to 3 months
Secondary	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)	Change from baseline to 3 months
Secondary	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	At 3-months follow-up assessment visit
Secondary	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	Change from baseline to 3 months