Consequences of Respiratory Devices on Caregivers (CAP2)

Asten Santé

Status: Enrolling

Conditions: Quality of Life

Treatments: Other: quality of life questionnaires

Study type: Observational

Funder types: Industry

Identifiers

NCT04632836

20.06.11.64653 (Registry Identifier)

20-ASTE-01

2020-A01741-38 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

350 participants in 3 patient groups

NIV participant (non invasive-ventilation participant)

Description:

From patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)

Treatment:

Other: quality of life questionnaires

CPAP participant (continuous positive airway pressure participant)

Description:

From patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)

Treatment:

Other: quality of life questionnaires

LTOT participant (long term oxygen therapy participant)

Description:

From patient: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * equipment data (type, indication, parameters, observance, usage data), * medical data (EFR, blood gas, respiratory polygraphy, pulse oxymetry, medical history, smoking status) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire) From partner: * demographics data (date of birth, gender, socio-professional category, education level, morphometric data) * responses of questionnaires (WHOQOL-BREF questionnaire, PSQI index, HADS scale, study specific questionnaire)

Treatment:

Other: quality of life questionnaires