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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
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In the study benefits of using mobile phone assisted remote patient monitoring including self-measurements of blood pressure, heart rate and weight as well as monitoring of personal health status are investigated in the care of heart failure patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring assisted self-care | Active Comparator | Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring. |
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| Control group | No Intervention | Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of heart failure (HF) patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring assisted self-care | Device | Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Number of HF-related Hospital Days | Number of heart failure related hospital days | From baseline until the end of the study at six months |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death from any cause | From baseline until the end of the study at six months |
| Heart Transplant | Heart transplant operation or listing for transplant operation |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study | Change in plasma concentrations of creatinine, natrium, and potassium | From baseline to the end of the study at six months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VTT Technical Research Centre of Finland | Espoo | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25498992 | Derived | Vuorinen AL, Leppanen J, Kaijanranta H, Kulju M, Helio T, van Gils M, Lahteenmaki J. Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial. J Med Internet Res. 2014 Dec 11;16(12):e282. doi: 10.2196/jmir.3651. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Telemonitoring Assisted Self-care | Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring. |
| FG001 | Control Group | Control group received multidisciplinary care that was standard. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Telemonitoring-assisted Self-care | Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of HF-related Hospital Days | Number of heart failure related hospital days | Posted | Mean | Standard Deviation | number of days | From baseline until the end of the study at six months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Telemonitoring Assisted Self-care | Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week. Telemonitoring assisted self-care: The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna-Leena Orsama | VTT Technical Research Centre of Finland | +358408485966 | anna-leena.orsama@vtt.fi |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
| From baseline until the end of the study at six months |
| P-proBNP | Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study. | From baseline until the end of the study at six months |
| EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores | Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed. | From baseline until the end of the study at six months |
| Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction from baseline until the end of the study | From baseline until the end of the study at six months |
| Utilization of Health Care Resources | Number of visits to nurse's reception | From baseline until the end of the study at six months |
| BG001 | Control Group | Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| left ventricular ejection fraction | Mean | Standard Deviation | percentage |
|
| NYHA ( Functional Classification of the New York Heart Association) | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Smoking | Number | participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| NT-proBNP | Plasma concentration of brain natriuretic peptide propeptide | Median | Inter-Quartile Range | ng/l |
|
| OG001 | Control Group | Control group received usual care |
|
|
| Secondary | Death | Death from any cause | Posted | Number | participants | From baseline until the end of the study at six months |
|
|
|
| Secondary | Heart Transplant | Heart transplant operation or listing for transplant operation | Posted | Number | participants | From baseline until the end of the study at six months |
|
|
|
| Secondary | P-proBNP | Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study. | Posted | Median | Inter-Quartile Range | ng/l | From baseline until the end of the study at six months |
|
|
|
| Secondary | EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores | Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed. | Posted | Mean | 95% Confidence Interval | Scores on a scale | From baseline until the end of the study at six months |
|
|
|
| Other Pre-specified | Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study | Change in plasma concentrations of creatinine, natrium, and potassium | Not Posted | From baseline to the end of the study at six months |
| Secondary | Left Ventricular Ejection Fraction | Change in left ventricular ejection fraction from baseline until the end of the study | Posted | Mean | 95% Confidence Interval | percentage unit | From baseline until the end of the study at six months |
|
|
|
| Secondary | Utilization of Health Care Resources | Number of visits to nurse's reception | Posted | Mean | Standard Deviation | number of visits | From baseline until the end of the study at six months |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Control Group | Control group received usual care | 0 | 47 | 0 | 47 |
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| D001519 | Behavior |