Holistic Wellbeing in COPD: The Communication About Sexuality (COSY) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Quality of life in old age (CASP-12)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of life in old age (CASP-12)
时间窗: Change from baseline to 3 months
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)
次要结局
- 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)
- 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)
- 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)
- Exacerbations of COPD (event based, patient reported)(At 3-months follow-up assessment visit)
- Symptoms of anxiety and depression (Hospital Anxiety and Depression Scale; HADS)(Change from baseline to 3 months)
研究者
Anja Frei
Principal Investigator
University of Zurich