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Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider (i-tech PPC)

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tele-visit
Sponsored by
AGIR à Dom
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring tele-visit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider. Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion Exclusion Criteria: Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring Unacceptable level of mask leakage Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom. Patient considered by the investigator to be unfit for a tele-visit

Sites / Locations

  • AGIR à dom.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

tele-visit by HCP

home visit by HCP

Arm Description

Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year

Standard care : patients receive an annual CPAP home visit by HCP technician

Outcomes

Primary Outcome Measures

To compare CPAP compliance between the two management modalities
CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report

Secondary Outcome Measures

To compare overall patient satisfaction between the two management modalities
The Consumer Satisfaction Questionnaire (CSQ-8) mean score between intervention and control groups, after the CPAP (tele-)visit follow-up . The overall score is calculated by adding the respondent's evaluation score (item evaluation) for each item on the scale. For the CSQ-8 version, the scores therefore range from 8 to 32, with higher values indicating greater satisfaction.
To compare the impact on daytime sleepiness between the two management modalities
Epworth Sleepiness Scale (ESS) mean score between intervention and control group. All items are assumed to be integers (0-3). The ESS score is the sum of 8 item scores. 0-10 = normal range of sleepiness in healthy adults 11 to 14 = mild sleepiness 15 to 17 = moderate sleepiness 18 to 24 = severe sleepiness
To compare impact on quality of life between the two management modalities
The EuroQol 5 Dimensions - 5 levels (EQ5D-5L) questionnaire mean score between intervention and control group, adjusted on the baseline score. it's composed of two parts : A visual analog scale (20 cm line, graduated from 0 to 100 where patient indicates his or her current state of health, 0 being the worst and 100 the best) the completion of 5 items evaluating mobility, autonomy, daily activities, pain or discomfort and anxiety or depression. indicating no problem indicating slight problems indicating moderate problems indicating severe problems indicating unable to/extreme problems Each state is referred to by a 5-digit code.
To compare CPAP compliance in medium term between the two management modalities
CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report
To compare impact on CPAP continuation between the two management modalities
Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants
To compare treatment effectiveness between the two management modalities
Apnea Hypopnea Index (AHI) mean between intervention and control group. AHI corresponds to the number of apneas and hypopneas per hour of sleep, collected on the CPAP remote monitoring report.
To compare treatment quality on mask leakage between the two management modalities
Leakage mean level between intervention and control group
To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities
The Side-Effects to CPAP treatment Inventory (SECI) mean score between the intervention and control group. Each of the 15 items relating to side effects associated with CPAP treatment has three subscales: frequency, breadth of the side effect, and impact on CPAP use. For each subscale, the patient will complete a five-point Likert-type scale, so the possible range for each subscale is 15 to 75. A higher score indicates greater frequency of side effects, greater breadth of side effects, and greater intensity of side effects.
To compare follow-up impact in addition to the annual visit between the two management modalities
Mean number of calls and visits made per patient between control and intervention group
To evaluate failed visits number between the two care modalities
Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...)
To evaluate patient satisfaction with tele-visits
The Televisit Satisfaction Questionnaire (TSQ) mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.
To evaluate technician satisfaction with tele-visits
The Televisit Satisfaction Questionnaire (TSQ) questionnaire mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.

Full Information

First Posted
November 18, 2022
Last Updated
July 20, 2023
Sponsor
AGIR à Dom
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1. Study Identification

Unique Protocol Identification Number
NCT05653804
Brief Title
Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider
Acronym
i-tech PPC
Official Title
Impact of Tele-visit Versus Home Visit by Home Care Provider on Compliance With Continuous Positive Airway Pressure (CPAP) Therapy of Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGIR à Dom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)
Detailed Description
Obstructive sleep apnea (OSA) syndrome is a chronic respiratory pathology affecting 4% of french adult population and reference treatment for moderate to severe forms of obstructive sleep apnea syndrome (OSA) is continuous positive airway pressure (CPAP). However, CPAP treatment is binding, so nearly a quarter of patients abandoning treatment at 1 year and nearly half of them at 3 years. Support for these patients on CPAP must therefore be optimal and seek patient satisfaction; HCP (Home Care Provider) plays an important role in this follow-up. Since 2018 in France, teleconsultation entered on common law but was little used. The pandemic has disrupted the habits of care and patients monitoring by developing remote monitoring. Home Care Providers (HCP) have also been forced to organize remote monitoring, particularly for the annual follow-up visit (technical tele-visit). The impact of the annual follow-up visits of HCP by tele-visit has never been clinically evaluated. If its clinical relevance were demonstrated and patient satisfaction confirmed, this follow-up modality could become, like telecare, a new standard for the follow-up of patients on CPAP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
tele-visit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, interventional, randomized controlled, open-label, single-center, multi-site
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tele-visit by HCP
Arm Type
Experimental
Arm Description
Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year
Arm Title
home visit by HCP
Arm Type
No Intervention
Arm Description
Standard care : patients receive an annual CPAP home visit by HCP technician
Intervention Type
Procedure
Intervention Name(s)
tele-visit
Intervention Description
The remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data.
Primary Outcome Measure Information:
Title
To compare CPAP compliance between the two management modalities
Description
CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report
Time Frame
Over the 3 months (tele)visit follow-up
Secondary Outcome Measure Information:
Title
To compare overall patient satisfaction between the two management modalities
Description
The Consumer Satisfaction Questionnaire (CSQ-8) mean score between intervention and control groups, after the CPAP (tele-)visit follow-up . The overall score is calculated by adding the respondent's evaluation score (item evaluation) for each item on the scale. For the CSQ-8 version, the scores therefore range from 8 to 32, with higher values indicating greater satisfaction.
Time Frame
Immediately after the (tele-)visit follow-up
Title
To compare the impact on daytime sleepiness between the two management modalities
Description
Epworth Sleepiness Scale (ESS) mean score between intervention and control group. All items are assumed to be integers (0-3). The ESS score is the sum of 8 item scores. 0-10 = normal range of sleepiness in healthy adults 11 to 14 = mild sleepiness 15 to 17 = moderate sleepiness 18 to 24 = severe sleepiness
Time Frame
At 3 months after (tele-)visit follow-up
Title
To compare impact on quality of life between the two management modalities
Description
The EuroQol 5 Dimensions - 5 levels (EQ5D-5L) questionnaire mean score between intervention and control group, adjusted on the baseline score. it's composed of two parts : A visual analog scale (20 cm line, graduated from 0 to 100 where patient indicates his or her current state of health, 0 being the worst and 100 the best) the completion of 5 items evaluating mobility, autonomy, daily activities, pain or discomfort and anxiety or depression. indicating no problem indicating slight problems indicating moderate problems indicating severe problems indicating unable to/extreme problems Each state is referred to by a 5-digit code.
Time Frame
At 3 months after (tele-)visit follow-up
Title
To compare CPAP compliance in medium term between the two management modalities
Description
CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report
Time Frame
Over the 12 months (tele)visit follow-up
Title
To compare impact on CPAP continuation between the two management modalities
Description
Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants
Time Frame
Over the 12 months (tele)visit follow-up
Title
To compare treatment effectiveness between the two management modalities
Description
Apnea Hypopnea Index (AHI) mean between intervention and control group. AHI corresponds to the number of apneas and hypopneas per hour of sleep, collected on the CPAP remote monitoring report.
Time Frame
Over the 12 months (tele)visit follow-up
Title
To compare treatment quality on mask leakage between the two management modalities
Description
Leakage mean level between intervention and control group
Time Frame
Over the 3 months (tele)visit follow-up
Title
To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities
Description
The Side-Effects to CPAP treatment Inventory (SECI) mean score between the intervention and control group. Each of the 15 items relating to side effects associated with CPAP treatment has three subscales: frequency, breadth of the side effect, and impact on CPAP use. For each subscale, the patient will complete a five-point Likert-type scale, so the possible range for each subscale is 15 to 75. A higher score indicates greater frequency of side effects, greater breadth of side effects, and greater intensity of side effects.
Time Frame
Over the 3 months (tele)visit follow-up
Title
To compare follow-up impact in addition to the annual visit between the two management modalities
Description
Mean number of calls and visits made per patient between control and intervention group
Time Frame
Over the 12 months (tele)visit follow-up
Title
To evaluate failed visits number between the two care modalities
Description
Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...)
Time Frame
Over the 12 months (tele)visit follow-up
Title
To evaluate patient satisfaction with tele-visits
Description
The Televisit Satisfaction Questionnaire (TSQ) mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.
Time Frame
Immediately after the (tele-)visit follow-up
Title
To evaluate technician satisfaction with tele-visits
Description
The Televisit Satisfaction Questionnaire (TSQ) questionnaire mean score 14 items, rated between 1 and 5 by the patient. The sum of the items corresponds to a score ranging from 14 to 70.
Time Frame
Immediately after the (tele-)visit follow-up
Other Pre-specified Outcome Measures:
Title
To evaluate patient overall satisfaction regarding clinical study participation
Description
Survey Satisfaction
Time Frame
Over the 3 months (tele)visit follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider. Compliance with CPAP ≥ 4h/night and AHI ≤ 5 events/hour on machine report for the 3 months prior to inclusion Exclusion Criteria: Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring Unacceptable level of mask leakage Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom. Patient considered by the investigator to be unfit for a tele-visit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline Socquet
Phone
0763236615
Email
p.socquet@agiradom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Christian BOREL, PhD
Organizational Affiliation
AGIR à Dom
Official's Role
Principal Investigator
Facility Information:
Facility Name
AGIR à dom.
City
Meylan
ZIP/Postal Code
38240
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline PERINET MARQUET
Email
p.perinet-marquet@agiradom.com
First Name & Middle Initial & Last Name & Degree
Jean-Christian Borel
First Name & Middle Initial & Last Name & Degree
Pauline Perinet-Marquet
First Name & Middle Initial & Last Name & Degree
Sandra Journet

12. IPD Sharing Statement

Learn more about this trial

Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider

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