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NCT Number: NCT05653804

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AGIR à dom.

Meylan, 38240, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tele-visit

Procedure

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 outcomes

  1. To compare CPAP compliance between the two management modalities

    Time frame: Over the 3 months (tele)visit follow-up

    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 outcomes

  1. To compare overall patient satisfaction between the two management modalities

    Time frame: Immediately after the (tele-)visit follow-up

    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.

  2. To compare the impact on daytime sleepiness between the two management modalities

    Time frame: At 3 months after (tele-)visit follow-up

    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

  3. To compare impact on quality of life between the two management modalities

    Time frame: At 3 months after (tele-)visit follow-up

    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.

  4. To compare CPAP compliance in medium term between the two management modalities

    Time frame: Over the 12 months (tele)visit follow-up

    CPAP mean compliance between intervention and control group : in hours/day, collected on the CPAP remote monitoring report

  5. To compare impact on CPAP continuation between the two management modalities

    Time frame: Over the 12 months (tele)visit follow-up

    Rate of CPAP removal between intervention and control group ; the number of CPAP unbundling among participants

  6. To compare treatment effectiveness between the two management modalities

    Time frame: Over the 12 months (tele)visit follow-up

    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.

  7. To compare treatment quality on mask leakage between the two management modalities

    Time frame: Over the 3 months (tele)visit follow-up

    Leakage mean level between intervention and control group

  8. To compare occurrence frequency of CPAP-related adverse effect(s) between the two management modalities

    Time frame: Over the 3 months (tele)visit follow-up

    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.

  9. To compare follow-up impact in addition to the annual visit between the two management modalities

    Time frame: Over the 12 months (tele)visit follow-up

    Mean number of calls and visits made per patient between control and intervention group

  10. To evaluate failed visits number between the two care modalities

    Time frame: Over the 12 months (tele)visit follow-up

    Mean number of (tele-)visits requiring a reprogramming (absence, technical problem, last minute deprogramming, home visit...)

  11. To evaluate patient satisfaction with tele-visits

    Time frame: Immediately after the (tele-)visit follow-up

    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.

  12. To evaluate technician satisfaction with tele-visits

    Time frame: Immediately after the (tele-)visit follow-up

    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.

  13. Comparison of the environmental impact associated with the two patient follow-up methods (home visit versus tele-visit)

    Time frame: Over the 12 months (tele)visit follow-up

    Comparison of the carbon emissions generated by each care modality, calculated over the entire patient participation period and expressed in kgCO₂e, considering only the impact of the follow-up method itself, without including the individual use of the CPAP device.

Other outcomes

  1. To evaluate patient overall satisfaction regarding clinical study participation

    Time frame: Over the 3 months (tele)visit follow-up

    Survey Satisfaction

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Registry information

Official study 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

Acronym: i-tech PPC

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2022
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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