Heart at Home- a Self-care Study

Overview

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.

Full Title of Study: “Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Death
    • Time Frame: From baseline until the end of the study at six months
    • Death from any cause
  • Heart Transplant
    • Time Frame: From baseline until the end of the study at six months
    • Heart transplant operation or listing for transplant operation
  • 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.
  • 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.
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VTT Technical Research Centre of Finland
  • Collaborator
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.