Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

NCT05696730 | Completed

• 1 other identifier: COSY
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Disease; Lung Diseases, Obstructive; Respiratory Disease

Keywords

Quality of life; COPD; Intimacy and sexuality; Communication intervention; Physical activity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty)

  Change from baseline to 3 months, measured during 1 week

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

  Change from baseline to 3 months

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

  Change from baseline to 3 months

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

  Change from baseline to 3 months

• Health status (Feeling Thermometer; FT)

  Change from baseline to 3 months

Other Outcomes (2)

• Experience and feedback with the counselling program of the health professionals

  At 3-months follow-up assessment visit

• Experience and satisfaction with the counselling program of the participants

  At 3-months follow-up assessment visit

Study Arms (2)

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.

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.

Interventions

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.

Communication intervention about sexuality in people with COPD

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University of Zurich / Epidemiology, Biostatistics and Prevention Institute

Zurich, 8001, Switzerland

Location

MeSH Terms

Conditions

Chronic Disease; Lung Diseases, Obstructive; Respiration Disorders; Pulmonary Disease, Chronic Obstructive; Sexuality; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Sexual Behavior; Behavior

Study Officials

• Anja Frei, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the kind of intervention and the organizational structure of the study centre, neither patients nor assessors can be blinded, but data analysts will be blinded to group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to either the control or intervention group.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: March 21, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

CH (1)