Clinical trial NCT04632836: Consequences of Respiratory Devices on Caregivers (CAP2)
Official title: Consequences of Respiratory Devices on Caregivers: CAP2 Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Keywords: quality of life
Home respiratory equipment
caregivers
Non-invasive ventilation
continuous positive airway pressure
long term oxygen therapy
Lead sponsor: Asten Sante
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Partners of adults patients who have home respiratory devices for chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome or other respiratory insuffisance disease and who share a same household.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)
timeFrame: 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)
Secondary outcomes:
measure: Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
timeFrame: 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)
measure: Patient's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire) for each equipment type
timeFrame: 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)
measure: Partner's quality of life evaluated with study specific questionnaire for each equipment type
timeFrame: 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)
measure: Patient's quality of life evaluated with study specific questionnaire for each equipment type
timeFrame: 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)
measure: Partner's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
timeFrame: 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)
measure: Patient's sleep quality evaluated with PSQI index (Pittsburgh Sleep Quality index) for each equipment
timeFrame: 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)
measure: Partner's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
timeFrame: 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)
measure: Patient's anxiety and humour score evaluated with HADS index (Hospital Anxiety and Depression scale) for each equipment
timeFrame: 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)
measure: Correlation between patient's answers and partner's answers for each questionnaire
timeFrame: statistics through study completion, an average of 6 months
measure: Correlation between patient's answers and his observance
timeFrame: statistics through study completion, an average of 6 months
measure: Correlation between partner's answers and patient's observance
timeFrame: statistics through study completion, an average of 6 months
Other outcomes:
Locations:
city: Isneauville
country: France
facility: Asten Sante
Study officials:
affiliation: APHP-Sorbonne Université, Service des Pathologies du Sommeil (Département R3S) Paris, France
name: Maxime Patout
role: PRINCIPAL_INVESTIGATOR
References: