Chronic Disease Clinical Trial
Official title:
Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
NCT number | NCT05696730 |
Other study ID # | COSY |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 21, 2023 |
Est. completion date | July 31, 2024 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Zurich / Epidemiology, Biostatistics and Prevention Institute | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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 |
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