Heart at Home- a Self-care Study
Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Espoo, Finlandia
- VTT Technical Research Centre of Finland
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-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- diagnosis of systolic heart failure
- NYHA (New York Heart Association) classification > 1
- left ventricular ejection fraction ≤ 35%
- need for a regular control visit
- time from the last visit no longer than 6 months
Exclusion Criteria:
- Patients who were known to enter a major medical operation
- severe comorbidity,
- participation in other clinical trial during last three months-
- poor compliance in terms of familiarity with mobile phone
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
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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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Nessun intervento: 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 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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of HF-related Hospital Days
Lasso di tempo: From baseline until the end of the study at six months
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Number of heart failure related hospital days
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From baseline until the end of the study at six months
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Death
Lasso di tempo: From baseline until the end of the study at six months
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Death from any cause
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From baseline until the end of the study at six months
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Heart Transplant
Lasso di tempo: From baseline until the end of the study at six months
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Heart transplant operation or listing for transplant operation
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From baseline until the end of the study at six months
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P-proBNP
Lasso di tempo: From baseline until the end of the study at six months
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Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
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From baseline until the end of the study at six months
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EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores
Lasso di tempo: From baseline until the end of the study at six months
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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.
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From baseline until the end of the study at six months
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Left Ventricular Ejection Fraction
Lasso di tempo: From baseline until the end of the study at six months
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Change in left ventricular ejection fraction from baseline until the end of the study
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From baseline until the end of the study at six months
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Utilization of Health Care Resources
Lasso di tempo: From baseline until the end of the study at six months
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Number of visits to nurse's reception
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From baseline until the end of the study at six months
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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
Lasso di tempo: From baseline to the end of the study at six months
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Change in plasma concentrations of creatinine, natrium, and potassium
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From baseline to the end of the study at six months
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- HUSHAH
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