Heart at Home- a Self-care Study

• ClinicalTrials.gov Identifier: NCT01759368
• Recruitment Status: Completed
• First Posted: January 3, 2013
• Results First Posted: September 17, 2014
• Last Update Posted: September 17, 2014
• Sponsor: VTT Technical Research Centre of Finland
• Collaborator: Helsinki University Central Hospital
• Information provided by (Responsible Party): VTT Technical Research Centre of Finland

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Device: Telemonitoring assisted self-care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 94 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients
• Study Start Date: October 2010
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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
No Intervention: 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

Outcome Measures

Primary Outcome Measures :

1. Number of HF-related Hospital Days [ Time Frame: From baseline until the end of the study at six months ]
   Number of heart failure related hospital days

Secondary Outcome Measures :

1. Death [ Time Frame: From baseline until the end of the study at six months ]
   Death from any cause
2. Heart Transplant [ Time Frame: From baseline until the end of the study at six months ]
   Heart transplant operation or listing for transplant operation
3. P-proBNP [ Time Frame: 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.
4. EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores [ Time Frame: 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.
5. Left Ventricular Ejection Fraction [ Time Frame: 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
6. Utilization of Health Care Resources [ Time Frame: From baseline until the end of the study at six months ]
   Number of visits to nurse's reception

Other Outcome Measures:

1. Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study [ Time Frame: From baseline to the end of the study at six months ]
   Change in plasma concentrations of creatinine, natrium, and potassium

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Finland

VTT Technical Research Centre of Finland

Espoo, Finland

Sponsors and Collaborators

VTT Technical Research Centre of Finland

Helsinki University Central Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vuorinen AL, Leppänen J, Kaijanranta H, Kulju M, Heliö T, van Gils M, Lähteenmäki J. Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial. J Med Internet Res. 2014 Dec 11;16(12):e282. doi: 10.2196/jmir.3651.

• Responsible Party: VTT Technical Research Centre of Finland
• ClinicalTrials.gov Identifier: NCT01759368
• Other Study ID Numbers: HUSHAH
• First Posted: January 3, 2013
• Results First Posted: September 17, 2014
• Last Update Posted: September 17, 2014
• Last Verified: September 2014

Keywords provided by VTT Technical Research Centre of Finland:

self-care, heart failure, telemonitoring, health care utilization

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases