Heart at Home- a Self-care Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759368
• Other study ID #: HUSHAH
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: September 15, 2014
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2014
• Source: VTT Technical Research Centre of Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• 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

Locations

Country	Name	City	State
Finland	VTT Technical Research Centre of Finland	Espoo

Sponsors (2)

Lead Sponsor	Collaborator
VTT Technical Research Centre of Finland	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study	Change in plasma concentrations of creatinine, natrium, and potassium	From baseline to the end of the study at six months	No
Primary	Number of HF-related Hospital Days	Number of heart failure related hospital days	From baseline until the end of the study at six months	No
Secondary	Death	Death from any cause	From baseline until the end of the study at six months	No
Secondary	Heart Transplant	Heart transplant operation or listing for transplant operation	From baseline until the end of the study at six months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Utilization of Health Care Resources	Number of visits to nurse's reception	From baseline until the end of the study at six months	No