| Primary | Number of All Causes Deaths and (Unplanned) Hospitalizations | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.46± 1.98
- OG0011.30± 1.85
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Number of events compared using a negative binomial regression model with log link for the expected rate of events (i.e., number of events divided by the effective duration of follow-up). Deaths that occurred during hospitalization with an overnight stay were counted as two events. | negative binomial regression | | =0.80 | | rate ratio | 0.97 | | | 2-Sided | 95 | 0.77 | 1.23 | | | | | Superiority | | |
|
| Primary | Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients) | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Primary | Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients | Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events) | ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score <45; or ii) Mental Component Summary score <35; or iii) combination of Mental Health score <50 plus Mental Component Summary score <40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Time to First Unplanned Hospital Readmission or Death From Any Cause | Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned | | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | All Causes Deaths - Number of Patients Who Died From Any Cause | Number of patients who died from any cause | | Posted | | Count of Participants | | Participants | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Time to Death From Any Cause | Time to death from any cause in the subgroup of patients who died | | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Number of Unplanned Hospitalizations for Any Cause | Number of unplanned hospitalizations for any cause (adjudicated events) | | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause | Composite morbidity-mortality criterion combining the number of cardiovascular unplanned hospitalizations and deaths from cardiovascular cause (adjudicated events) | | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Number of Unplanned Hospitalizations for Heart Failure | Number of unplanned hospitalizations for heart failure (adjudicated events) | | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients | Number of unplanned hospitalizations for heart failure (adjudicated events) | ITT population with New York Heart Association (NYHA) class III or IV at inclusion (N=460 patients) | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients | Number of unplanned hospitalizations for heart failure (adjudicated events) | ITT population with socially isolated status at inclusion (N=216 patients) defined as: either i) SF-36 Mental Health score <45; or ii) Mental Component Summary score <35; or iii) combination of Mental Health score <50 plus Mental Component Summary score <40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications | Posted | | Mean | Standard Deviation | Events | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Time to First Unplanned Hospital Readmission for Heart Failure | Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned | | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Secondary | Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores | Evolution of Quality of Life assessed using absolute changes from baseline of each dimension and both component summary scores of SF-36 questionnaire. Indeed, SF-36 questionnaire include 8 general dimensions and 2 composite scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). They are standardized to range between 0 and 100. Higher scores on all SF-36 scales indicate more favorable levels of functioning and less disability. Thus, higher Physical Functioning scores reflect higher physical functioning. Higher Role Physical scores reflect lower limitations due to physical problems. Higher Bodily Pain scores reflect less bodily pain. Higher General Health scores reflect higher general health perception. Higher Vitality scores reflect higher vitality. Higher Social Functioning scores reflect higher social functioning. Higher Role Emotional scores reflect lower limitations due to emotional problems. Higher Mental Health scores reflect better mental health. | | Posted | | Mean | Standard Deviation | score on a scale | | Between baseline and 12 months and between baseline and 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
|
| Secondary | Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period | Annualized number of unplanned hospitalizations for any cause according to investigators in patients hospitalized at least once during the extension period | | Posted | | Mean | Standard Deviation | Events | | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard Care/Tele-cardiology |
- Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
- Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
| | OG001 | Tele-cardiology/Tele-cardiology | - Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. - Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period. |
| |
| Secondary | Number of Patients Who Died From Any Cause During the Extension Period | Number of patients who died from any cause during the extension period | | Posted | | Count of Participants | | Participants | | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard Care/Tele-cardiology |
- Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
- Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
| | OG001 | Tele-cardiology/Tele-cardiology | - Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. - Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period. |
| |
| Secondary | Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period | Annualized number of unplanned hospitalizations from cardiovascular cause according to investigators in patients hospitalized at least once for cardiovascular cause during the extension period | | Posted | | Mean | Standard Deviation | Events | | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard Care/Tele-cardiology |
- Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
- Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
| | OG001 | Tele-cardiology/Tele-cardiology | - Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. - Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period. |
|
| Secondary | Number of Patients Who Died From Cardiovascular Cause During the Extension Period | Number of patients who died from cardiovascular cause according to investigators during the extension period | | Posted | | Count of Participants | | Participants | | Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months) | | | | ID | Title | Description |
|---|
| OG000 | Standard Care/Tele-cardiology |
- Period 1: Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists.
- Period 2: Patients on standard follow-up during Period 1 were equipped with the Telecardiology Program if they wished and consented to enter the extension period.
| | OG001 | Tele-cardiology/Tele-cardiology | - Period 1: The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. - Period 2: Patients on Telecardiology Program during Period 1 were allowed to continue it until its marketing if they wished and consented to enter the extension period. |
| |
| Post-Hoc | Time to First Unplanned Hospital Readmission or Death From Any Cause in NYHA Class III or IV Patients | Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned | New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Post-Hoc | Time to First Unplanned Hospital Readmission or Death From Any Cause in Socially Isolated Patients | Time to first unplanned hospital readmission (adjudicated events) or death from any cause, whichever occurred first in the subgroup of patients concerned | Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score <45; or ii) Mental Component Summary score <35; or iii) combination of Mental Health score <50 plus Mental Component Summary score <40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission or death from any cause included in the Overall Number of Participants Analyzed' | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Post-Hoc | Time to First Unplanned Hospital Readmission for Heart Failure in NYHA Class III or IV Patients | Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned | New York Heart Association (NYHA) class III or IV at inclusion patients with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |
| Post-Hoc | Time to First Unplanned Hospital Readmission for Heart Failure in Socially Isolated Patients | Time to first unplanned hospital readmission for heart failure (adjudicated events) in the subgroup of patients concerned | Patients with socially isolated status at inclusion defined as: either i) SF-36 Mental Health score <45; or ii) Mental Component Summary score <35; or iii) combination of Mental Health score <50 plus Mental Component Summary score <40; or iv) medical history of depression or mood disorders/alterations; or v) use of concomitant antidepressant medications and with unplanned hospital readmission for heart failure included in the Overall Number of Participants Analyzed' | Posted | | Median | Inter-Quartile Range | days | | 18 months | | | | ID | Title | Description |
|---|
| OG000 | Standard Care | Standard follow-up, with conventional monitoring involving consultations and monitoring by their general practitioners or referring cardiologists | | OG001 | Tele-cardiology Group | The telecardiology program is a combination of a scale, a device asking the patients questions about the symptoms associated with their heart failure, and regular phone calls made by nurses. Automatic algorithms have been built-up in order to detect early the need for a hospitalization due to heart failure. |
| |