Heart at Home- a Self-care Study

Not Applicable

Completed

• Conditions: Heart Failure

• 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

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-30
• Study First Posted: 2013-01-03
• Results First Submitted: 2014-08-07
• Status Verified: 2014-09
• Results First Submitted QC: 2014-09-15
• Last Update Submitted: 2014-09-15
• Results First Posted: 2014-09-17
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
Death	From baseline until the end of the study at six months	Death from any cause

Trial Locations

Locations (1)

VTT Technical Research Centre of Finland; 🇫🇮 Espoo, Finland