Heart at Home- a Self-care Study
Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Espoo, Finlandia
- VTT Technical Research Centre of Finland
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Aktywny komparator: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of HF-related Hospital Days
Ramy czasowe: 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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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Death
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- HUSHAH
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