NCT07524023进行中（未招募）不适用
Emotional-distress-based Integrated Care Programme in Patients With Stable COPD - A Feasibility Study (EmoD-2)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in COPD-related emotional distress (CRED)
研究概览
简要总结
The investigators have developed a new counselling service that focuses on the emotional distress experienced by people living with chronic obstructive pulmonary disease (*COPD*). The new programme is led by an advanced practice nursing (*APN*) team. Other professionals are involved in the programme, such as medical staff and physiotherapists. The new counselling service lasts three months. Patients will receive ten counselling sessions with a specialized nurse. The overall objective of the study is to assess the feasibility of the newly developed emotional-distress-based integrated care programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with a confirmed diagnosis of COPD (GOLD 1-4) and existing lung function in the past 12 months
- •Outpatient treatment on the pneumology clinic of the university hospital Zurich. Last consultation within the past 12 months
排除标准
- •Significant changes in symptoms over the past 3 months that exceeded the everyday fluctuations and required intensification of treatment (moderate, severe exacerbations or pneumonia) and no COPD-related hospitalisation in the past 3 months
- •Cognitive impairment (dementia, delirium)
- •Unstable psychiatric situation, i.e., current psychiatric treatment due to personality disorder, schizophrenia, drug use, suicidal tendencies. No exclusion for nicotine and alcohol abuse, anxiety, and depression
- •Not speaking or reading German
- •Intervention via telephone or video call not possible
- •Lung transplant (recipient or candidate)
研究组 & 干预措施
EmoD Intervention
Experimental
干预措施: EmoD Intervention (Other)
结局指标
主要结局
Change in COPD-related emotional distress (CRED)
时间窗: Quantitative data will be collected baseline, in the first month (Baseline measurement, week 0-4), and follow-up, three months after (week 14-17)]
Change in COPD-related emotional distress between baseline and month 3. COPD-related emotional distress will be assessed using the newly developed "COPD-Related Emotional Distress Questionnaire (CRED)", which was developed for CF and COPD patients (publication in progress; former name of the questionnaire: IRED-RESP). The questionnaire includes 36 items and assesses distress related to symptoms, treatment, restrictions in range of mobility and participation in social life, unpredictability of the disease and stigma, using a 5-point Likert scale. Higher scores mean more emotional distress (worse outcome).
次要结局
- Reach: Total number of patients who take up the programme(Four months)
- Reach: Percentage of patients who take part in at least one outpatient intervention(Four months)
- Reach: Reasons for participating in the programme (facilitators and barriers)(Four months)
- Reach: Reasons for ending (prematurely or on schedule) the programme (facilitators and barriers)(Four months)
- Potential effectiveness: Change in depression(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in anxiety(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health-related quality of life (*QoL*)(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Patient satisfaction with programme(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Number of moderate exacerbations within 3 months(Study duration per patient is three months, with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second, measurement will take place in month four (week 14-17).)
- Potential effectiveness: Number of severe exacerbations within 3 months(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Rehospitalisation at day 90(Study duration per patient is three months, with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second, measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour smoking- current status(Study duration per patient is three months, with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second, measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour smoking - ex- smoker(Study duration per patient is three months, with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second, measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour smoking -smoker(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour nutrition - body weight(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour nutrition - body height(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour nutrition - BMI(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour nutrition - NRS(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour physical activity - C-PPAC(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour physical activity - Pulmonary rehabilitation(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour inhalation adherence(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour action plan(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Potential effectiveness: Change in health behaviour oxygen use(Study duration per patient is three months with two measurement points. Baseline measurements will be applied in the first month (week 0-4). Second measurement will take place in month four (week 14-17).)
- Implementation: Percent of programme components carried out according to the intervention manual(Six months)
- Implementation: Acceptability of the programme(Six months)
- Implementation: Appropriateness of the programme(Six months)
- Implementation: Feasibility of the programme(Six months)
研究者
研究点 (1)
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