Heart at Home- a Self-care Study

This study has been completed.
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier:
NCT01759368
First received: December 20, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention
Heart Failure
Device: Telemonitoring assisted self-care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Heart at Home- Remote Patient Monitoring in the Care of Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by VTT Technical Research Centre of Finland:

Primary Outcome Measures:
  • Number of HF-related Hospital Days [ Time Frame: From baseline until the end of the study at six months ] [ Designated as safety issue: No ]
    Number of heart failure related hospital days


Secondary Outcome Measures:
  • Death [ Time Frame: From baseline until the end of the study at six months ] [ Designated as safety issue: No ]
    Death from any cause

  • Heart Transplant [ Time Frame: From baseline until the end of the study at six months ] [ Designated as safety issue: No ]
    Heart transplant operation or listing for transplant operation

  • P-proBNP [ Time Frame: From baseline until the end of the study at six months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of visits to nurse's reception


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Change in plasma concentrations of creatinine, natrium, and potassium


Enrollment: 94
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759368

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

No publications provided

Responsible Party: VTT Technical Research Centre of Finland
ClinicalTrials.gov Identifier: NCT01759368     History of Changes
Other Study ID Numbers: HUSHAH
Study First Received: December 20, 2012
Results First Received: August 7, 2014
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014