Heart at Home- a Self-care Study
- Conditions
- Heart Failure
- Interventions
- Device: Telemonitoring assisted self-care
- Registration Number
- NCT01759368
- Lead Sponsor
- VTT Technical Research Centre of Finland
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemonitoring assisted self-care 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.
- Primary Outcome Measures
Name Time Method Number of HF-related Hospital Days From baseline until the end of the study at six months Number of heart failure related hospital days
- Secondary Outcome Measures
Name Time Method Death From baseline until the end of the study at six months Death from any cause
Heart Transplant From baseline until the end of the study at six months Heart transplant operation or listing for transplant operation
P-proBNP From baseline until the end of the study at six months Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.
EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores From baseline until the end of the study at six months 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.
Left Ventricular Ejection Fraction From baseline until the end of the study at six months Change in left ventricular ejection fraction from baseline until the end of the study
Utilization of Health Care Resources From baseline until the end of the study at six months Number of visits to nurse's reception
Trial Locations
- Locations (1)
VTT Technical Research Centre of Finland
🇫🇮Espoo, Finland