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Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

Primary Purpose

Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Communication intervention about sexuality in people with COPD
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Disease focused on measuring Quality of life, COPD, Intimacy and sexuality, Communication intervention, Physical activity, Randomized controlled trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Zurich / Epidemiology, Biostatistics and Prevention InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Communication intervention about sexuality in people with COPD

30 minutes counselling and intervention material per request after the RCT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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
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
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)
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)
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
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

Full Information

First Posted
January 13, 2023
Last Updated
May 16, 2023
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05696730
Brief Title
Holistic Wellbeing in COPD: Communication About Sexuality (COSY)
Official Title
Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Lung Diseases, Obstructive, Respiratory Disease
Keywords
Quality of life, COPD, Intimacy and sexuality, Communication intervention, Physical activity, Randomized controlled trial

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to either the control or intervention group.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Communication intervention about sexuality in people with COPD
Arm Type
Experimental
Arm Description
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.
Arm Title
30 minutes counselling and intervention material per request after the RCT
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Communication intervention about sexuality in people with COPD
Intervention Description
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 Outcome Measure Information:
Title
Quality of life in old age (CASP-12)
Description
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)
Time Frame
Change from baseline to 3 months
Secondary Outcome Measure Information:
Title
Physical activity (PROactive physical activity in COPD instrument, clinical visit version [C-PPAC]; domains amount and difficulty)
Description
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)
Time Frame
Change from baseline to 3 months, measured during 1 week
Title
Functional exercise capacity (1-min Sit-to-Stand [STS] test)
Description
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
Time Frame
Change from baseline to 3 months
Title
COPD-specific health-related quality of life (Chronic Respiratory Questionnaires [CRQ] Subscales)
Description
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
Time Frame
Change from baseline to 3 months
Title
COPD-specific health status / Symptoms (COPD Assessment Test; CAT)
Description
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)
Time Frame
Change from baseline to 3 months
Title
Health status (Feeling Thermometer; FT)
Description
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)
Time Frame
Change from baseline to 3 months
Title
Exacerbations of COPD (event based, patient reported)
Description
The event-based definition required an increase in symptoms and an increase in dosage of or new prescription of systemic corticosteroids and/or antibiotics
Time Frame
At 3-months follow-up assessment visit
Title
Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)
Description
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
Time Frame
Change from baseline to 3 months
Other Pre-specified Outcome Measures:
Title
Experience and feedback with the counselling program of the health professionals
Description
Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)
Time Frame
At 3-months follow-up assessment visit
Title
Experience and satisfaction with the counselling program of the participants
Description
Semi-structured interview, outcomes will be qualitatively assessed (no scale is used)
Time Frame
At 3-months follow-up assessment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Steurer-Stey, PhD
Phone
+41 44 635 39 39
Email
claudia.steurer-stey@uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Frei, PhD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich / Epidemiology, Biostatistics and Prevention Institute
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Steurer-Stey, MD, PhD
Phone
+41 44 635 39 39
Email
claudia.steurer@uzh.ch
First Name & Middle Initial & Last Name & Degree
Anja Frei, PhD

12. IPD Sharing Statement

Learn more about this trial

Holistic Wellbeing in COPD: Communication About Sexuality (COSY)

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