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

Obstructive Sleep Apnea Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653804
• Other study ID #: 2022-A02309-34
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: July 2023
• Source: AGIR à Dom
• Contact: Pauline Socquet
• Phone: 0763236615
• Email: p.socquet[@]agiradom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• tele-visit
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.

Locations

Country	Name	City	State
France	AGIR à dom.	Meylan

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To evaluate patient overall satisfaction regarding clinical study participation	Survey Satisfaction	Over the 3 months (tele)visit follow-up
Primary	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	Over the 3 months (tele)visit follow-up
Secondary	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.	Immediately after the (tele-)visit follow-up
Secondary	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	At 3 months after (tele-)visit follow-up
Secondary	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.	At 3 months after (tele-)visit follow-up
Secondary	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	Over the 12 months (tele)visit follow-up
Secondary	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	Over the 12 months (tele)visit follow-up
Secondary	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.	Over the 12 months (tele)visit follow-up
Secondary	To compare treatment quality on mask leakage between the two management modalities	Leakage mean level between intervention and control group	Over the 3 months (tele)visit follow-up
Secondary	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.	Over the 3 months (tele)visit follow-up
Secondary	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	Over the 12 months (tele)visit follow-up
Secondary	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...)	Over the 12 months (tele)visit follow-up
Secondary	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.	Immediately after the (tele-)visit follow-up
Secondary	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.	Immediately after the (tele-)visit follow-up