NCT04632836

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

November 10, 2020

Last Update Submit

July 25, 2022

Conditions

Quality of Life

Keywords

quality of lifeHome respiratory equipmentcaregiversNon-invasive ventilationcontinuous positive airway pressurelong term oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Partner's quality of life score evaluated with WHOQOL-BREF questionnaire (World Health Organization Quality of Life - Brief version questionnaire)

    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.

    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 (11)

  • 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)

  • 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)

  • 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 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)

  • 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)

  • +6 more secondary outcomes

Study Arms (3)

NIV participant (non invasive-ventilation participant)

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)

Other: quality of life questionnaires

CPAP participant (continuous positive airway pressure participant)

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)

Other: quality of life questionnaires

LTOT participant (long term oxygen therapy participant)

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)

Other: quality of life questionnaires

Interventions

quality of life questionnairesOTHER

responses for quality of life questionnaires (WHOQOL-BREF questionnaire, study specific questionnaire, PSQI index, HADS scale)

CPAP participant (continuous positive airway pressure participant)LTOT participant (long term oxygen therapy participant)NIV participant (non invasive-ventilation participant)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asten Sante

Isneauville, France

RECRUITING

Study Officials

  • Maxime Patout

    APHP-Sorbonne Université, Service des Pathologies du Sommeil (Département R3S) Paris, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Dupuis

CONTACT

+33789207533jdupuis@astensante.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2020

First Posted

November 17, 2020

Study Start

January 20, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All specific individual participant data that underlie results in a publication will be made available upon reasonable request to the principal investigator

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will become available at the end of the study for time necessary to published and over a maximum of fifteen years (maximum time to store data on the online platform)
Access Criteria
Upon reasonable request to the principal investigator

Locations

FR(1)