A Psychological Intervention to Promote Acceptance and Adherence to Non-Invasive Ventilation (NIV) in People With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D)
研究概览
简要总结
This study aims to analyze the impact of a brief psychological support intervention in the promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of this intervention on both physical and psychological well-being, and consequently, a reduction of health costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age> or =18 years
- •the voluntary participation to the Study
- •inpatients or outpatients
- •subjects with Chronic Obstructive Pulmonary Disease (COPD), from moderate (GOLD 2- 50% ≤ FEV1 <80% pred.) to severe (GOLD 3- 30% ≤ FEV1 <50%pred.) (FEV1= Forced Expiratory Volume in the 1st Second)
排除标准
- •refusal of the Informant Consent
- •pregnancy
- •subjects affected by oncological or psychiatric illnesses
- •immune depressive condition as the principal condition
- •usage of antidepressant drugs
研究组 & 干预措施
Psychological Intervention
In addition to the standard care, subjects are participating in a brief psychological support, which will include elements of psychological well-being's promotion and cognitive restructuring exercises (mindfulness).
干预措施: Psychological Intervention (Behavioral)
Videos
The subjects assigned in the Control Group watch some videos relating to the management of their disease.
干预措施: Videos (Behavioral)
结局指标
主要结局
Change from baseline in Quality of Life (QoL) in COPD patients at 3, 6 and 12 months as measured by EuroQoL (EQ5D)
时间窗: Baseline + After 3, 6 and 12 months following the recruitment
EuroQoL or EQ5D, a simple and short questionnaire consists of two distinct sections: the first in which there are five items (mobility, self-care, usual activities, pain / discomfort, anxiety / depression), concerning the status of health of the subject, which is required to indicate the severity level; the second section includes a visual-analogue scale instead represented graphically as a thermometer graduated from 0 (worst possible health status) to 100 (best possible health state), on which the respondent must indicate the level of perceived health at the time. All subjects will be assigned to psychometric assessment.
次要结局
- Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by a modified version of the Beliefs About Medicine Questionnaire (BMQ)(Baseline + After 3, 6 and 12 months following the recruitment)
- Change from baseline in acceptance NIV in COPD patients at 3, 6 and 12 months as measured by weekly means and standard deviations of hours of use of Non Invasive Ventilation (NIV)(Baseline + After 3, 6 and 12 months following the recruitment)