Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

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).

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Obstructive; Chronic Disease; Respiratory Disease
• Intervention / Treatment: Other: Communication intervention about sexuality in people with 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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8001
    • University of Zurich / Epidemiology, Biostatistics and Prevention Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Communication intervention about sexuality in people with COPD; 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.	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.
No Intervention: 30 minutes counselling and intervention material per request after the RCT; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Anja Frei, PhD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: COPD; Quality of life; Randomized controlled trial; Physical activity; Intimacy and sexuality; Communication intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Lung Diseases; Lung Diseases, Obstructive; Respiratory Tract Diseases; Respiration Disorders; Chronic Disease
• Other Study ID Numbers: COSY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No