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| Name | Class |
|---|---|
| Heinen und Löwenstein GmbH & Co. KG | INDUSTRY |
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This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.
54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology.
Primary objective:
Adherence to ventilation in the intervention group versus control group.
Secondary objective:
Comparisons between the control and intervention groups, over time and against each other, in terms of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. Standard care according to clinical standard (technical support by the provider and three hospital follow-up appointments after 2, 6 and after 12 months) with assessment of health status and NIV therapy settings. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. Therapy data from NIV device. |
|
| Telemonitoring | Experimental | Home non-invasive mask ventilation with prisma VENT device. Modem for the daily transmission of specific therapy parameters. An electronic feedback system provides patients with feedback and recommendations on their therapy based on the data submitted. The study center regularly reviews and reacts to all therapy data and other information according to the remote care scheme of intervention. Telemonitoring care patients also receive an SpO2 sensor for monitoring of oxygen saturation. Ambulantory implementation of three blood gas analyses to check the health status after 2, 6 and 12 months. There are no regular routine inpatient stays. Study specific: During visits, recording of HRQOL by SGRQ and S3NIV questionnaires, hospitalizaion and physician visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring Care | Other | NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence [hours/day] | Usage of Ventilator in hours per day | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| QOL [unit] | Health related Quality of Life by SGRQ-Score [higher units represent worse outcome] | Survey at 3 dates: 2, 6 und 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations [Nr] | Number of hospitalizations/physician visits | 12 Months |
| CAT [score] | COPD Assessment Test, Score 0 to 40, higher units represent worse outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gearg Nilius, MD | KEM | Evang. Kliniken Essen-Mitte gGmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evang. Kliniken Essen-Mitte gGmbH | Essen | North Rhine-Westphalia | 45276 | Germany |
All IPD that underlie results in a publication
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Starting 6 months and ending 24 months following article publication,
Investigators whose proposed use of the data has been approved by an independent review commitee identified for this purpose. Proposals may be submitted upt to 24 months following article publication.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Prospective, double-arm, controlled-randomized clinical trial
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| Standard Care | Other | NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems |
|
| Survey at 3 dates: 2, 6 und 12 Months |
| mMRC [score] | Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome | Survey at 3 dates: 2, 6 und 12 Months |
| S3-NIV [score] | S3-NIV questionnaire for the assessment of home NIV, Score 0 to10, lower units represent worse outcome | Survey at 3 dates: 2, 6 und 12 Months |
| PCO2 [mmHg] | Carbon dioxide partial pressure from Blood Gas Analysis | Survey at 3 dates: 2, 6 und 12 Months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |