Consequences of Respiratory Devices on Caregivers: CAP2 Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)
研究概览
简要总结
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.
The investigators will examine the impact of home respiratory devices on quality of life in general, sleep quality, anxiety and humour depending on equipment type (Non-invasive ventilation (NIV), continuous positive airway pressure (CPAP) or long-term oxygen therapy (LTOT)) for patients and partners. The investigators will assess the correlation between patient and caregiver's answers. The investigators will assess the correlation between couple's quality of life and adherence to treatment.
To do this, the investigators will use four quality of life questionnaires and the investigators will collect demographic data, medical data and usage report from the equipment.
详细描述
Home respiratory devices improve patients' quality of life and clinical outcomes. However, they bring medical equipment into the bedroom and are used overnight. The aim of this prospective cohort is to assess the quality of life of patient's caregivers.
Patient caregivers' quality of life will be assessed using the WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire).
The investigators expect to enroll 200 patients' partners equipped with non-invasive ventilation, 100 patients' partners equipped with continuous positive airway pressure and 50 patients' partners equipped with long-term oxygen therapy. Patients will be recruited from the cohort of patients already established on home treatment and cared for by Asten Santé.
After consent, patient will receive dedicated questionnaires. During a home visit, home healthcare provider technician will retrieve data from the home device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the patient :
- •Patient with a diagnostic of chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome
- •Home respiratory equipment (NIV, CPAP or LTOT) since more than 3 months, patient and partner who shared the same household
- •patient with medical stable condition
- •patient who consents
- •patient older than 18 years old
- •patient followed at Rouen University Hospital
- •For the partner :
- •patient who consents
- •patient older than 18 years old
排除标准
- •For the patient :
- •Home respiratory equipment for neuromuscular disease
- •Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- •patient not able to consent
- •For the partner :
- •Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship)
- •patient not able to consent
结局指标
主要结局
Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)
时间窗: The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call)
Total quality of life score on WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire). This questionnaire contains 26 items and addresses four quality of life domains. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5) to determine a raw item score. The first and the second questions of the questionnaire are examined separately. For the other questions, the mean score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score . For each domain, the minimum domain score is 4 and the maximum domain score is 20. It corresponds to a minimum scaled score of 0 and a maximum scale score of 100 for each domain. A higher score indicating a higher QOL.
次要结局
- Correlation between partner's answers and patient's observance(statistics through study completion, an average of 6 months)
- Patient's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Patient's quality of life evaluated with study specific questionnaire for each equipment type(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Patient's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Correlation between patient's answers and his observance(statistics through study completion, an average of 6 months)
- Partner's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Partner's quality of life evaluated with study specific questionnaire for each equipment type(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Patient's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Partner's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type(The assessment will take place during the inclusion call (or in the following 10 days, during the respiratory devices provider's visit if the participant was unavailable to answer to the questionnaire during the inclusion call))
- Correlation between patient's answers and partner's answers for each questionnaire(statistics through study completion, an average of 6 months)