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Completed

NCT Number: NCT01759368

Heart at Home- a Self-care Study

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.

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Key information

Conditions

Heart Failure Behavior Cardiovascular Diseases Health Behavior Heart Diseases Patient Acceptance of Health Care Treatment Adherence and Compliance

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VTT Technical Research Centre of Finland

Espoo, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring assisted self-care

Device

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

VTT Technical Research Centre of Finland

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 3, 2013
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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