Heart at Home- a Self-care Study

Study Overview
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Brief Summary
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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.

Official Title
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Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Telemonitoring assisted self-care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemonitoring assisted self-care<br>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. | Device: Telemonitoring assisted self-care<br>* 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<br>|
| No Intervention: Control group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-care, heart failure, telemonitoring, health care utilization